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Last Updated: April 18, 2024

List of Excipients in API varenicline tartrate

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Excipients in NDA-approved (novel) drugs containing varenicline tartrate

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Company	Tradename	Ingredient	NDC	Excipient	Potential Generic Entry
Pfizer Laboratories Div Pfizer Inc	CHANTIX	varenicline tartrate	0069-0468	ANHYDROUS DIBASIC CALCIUM PHOSPHATE
Pfizer Laboratories Div Pfizer Inc	CHANTIX	varenicline tartrate	0069-0468	CELLULOSE, MICROCRYSTALLINE
Pfizer Laboratories Div Pfizer Inc	CHANTIX	varenicline tartrate	0069-0468	CROSCARMELLOSE SODIUM
Pfizer Laboratories Div Pfizer Inc	CHANTIX	varenicline tartrate	0069-0468	FD&C BLUE NO. 2
Pfizer Laboratories Div Pfizer Inc	CHANTIX	varenicline tartrate	0069-0468	HYPROMELLOSE
Pfizer Laboratories Div Pfizer Inc	CHANTIX	varenicline tartrate	0069-0468	MAGNESIUM STEARATE
>Company	>Tradename	>Ingredient	>NDC	>Excipient	>Potential Generic Entry

Excipients in ANDA-approved (generic) drugs containing varenicline tartrate

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Company	Ingredient	NDC	Excipient
Major Pharmaceuticals	varenicline tartrate	0904-7413	CELLULOSE, MICROCRYSTALLINE
Major Pharmaceuticals	varenicline tartrate	0904-7413	CROSCARMELLOSE SODIUM
Major Pharmaceuticals	varenicline tartrate	0904-7413	HYPROMELLOSE 2910
Major Pharmaceuticals	varenicline tartrate	0904-7413	MALTODEXTRIN
Major Pharmaceuticals	varenicline tartrate	0904-7413	POLYETHYLENE GLYCOL
Major Pharmaceuticals	varenicline tartrate	0904-7413	STEARIC ACID
>Company	>Ingredient	>NDC	>Excipient

Detailed excipient profiles for varenicline tartrate

Excipient focus: ANHYDROUS DIBASIC CALCIUM PHOSPHATE

varenicline tartrate drug variants containing ANHYDROUS DIBASIC CALCIUM PHOSPHATE

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Company	Ingredient	NDC
Pfizer Laboratories Div Pfizer Inc	varenicline tartrate	0069-0468
Rebel Distributors Corp	varenicline tartrate	21695-633
Ajanta Pharma USA Inc	varenicline tartrate	27241-173
Camber Pharmaceuticals Inc	varenicline tartrate	31722-678
AvKARE	varenicline tartrate	42291-927
Aphena Pharma Solutions - Tennessee LLC	varenicline tartrate	43353-899
>Company	>Ingredient	>NDC

varenicline tartrate drug variants not containing ANHYDROUS DIBASIC CALCIUM PHOSPHATE

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Company	Ingredient	NDC
Major Pharmaceuticals	varenicline tartrate	0904-7413
Medley Pharmaceuticals Limited	varenicline tartrate	42934-104
Par Pharmaceutical Inc	varenicline tartrate	49884-155
American Health Packaging	varenicline tartrate	60687-648
Carilion Materials Management	varenicline tartrate	68151-4952
Carilion Materials Management	varenicline tartrate	68151-4953
>Company	>Ingredient	>NDC

Excipient focus: BUTYLATED HYDROXYANISOLE

varenicline tartrate drug variants containing BUTYLATED HYDROXYANISOLE

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Company	Ingredient	NDC
Glenmark Pharmaceuticals Inc USA	varenicline tartrate	68462-893
>Company	>Ingredient	>NDC

varenicline tartrate drug variants not containing BUTYLATED HYDROXYANISOLE

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Company	Ingredient	NDC
Pfizer Laboratories Div Pfizer Inc	varenicline tartrate	0069-0468
Major Pharmaceuticals	varenicline tartrate	0904-7413
Rebel Distributors Corp	varenicline tartrate	21695-633
Ajanta Pharma USA Inc	varenicline tartrate	27241-173
Camber Pharmaceuticals Inc	varenicline tartrate	31722-678
AvKARE	varenicline tartrate	42291-927
>Company	>Ingredient	>NDC

Excipient focus: CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS

varenicline tartrate drug variants containing CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS

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Company	Ingredient	NDC
Medley Pharmaceuticals Limited	varenicline tartrate	42934-104
Carilion Materials Management	varenicline tartrate	68151-4952
Carilion Materials Management	varenicline tartrate	68151-4953
>Company	>Ingredient	>NDC

varenicline tartrate drug variants not containing CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS

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Company	Ingredient	NDC
Pfizer Laboratories Div Pfizer Inc	varenicline tartrate	0069-0468
Major Pharmaceuticals	varenicline tartrate	0904-7413
Rebel Distributors Corp	varenicline tartrate	21695-633
Ajanta Pharma USA Inc	varenicline tartrate	27241-173
Camber Pharmaceuticals Inc	varenicline tartrate	31722-678
AvKARE	varenicline tartrate	42291-927
>Company	>Ingredient	>NDC

Excipient focus: CELLULOSE, MICROCRYSTALLINE

varenicline tartrate drug variants containing CELLULOSE, MICROCRYSTALLINE

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Company	Ingredient	NDC
Pfizer Laboratories Div Pfizer Inc	varenicline tartrate	0069-0468
Major Pharmaceuticals	varenicline tartrate	0904-7413
Rebel Distributors Corp	varenicline tartrate	21695-633
Ajanta Pharma USA Inc	varenicline tartrate	27241-173
AvKARE	varenicline tartrate	42291-927
Medley Pharmaceuticals Limited	varenicline tartrate	42934-104
>Company	>Ingredient	>NDC

varenicline tartrate drug variants not containing CELLULOSE, MICROCRYSTALLINE

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Company	Ingredient	NDC
Camber Pharmaceuticals Inc	varenicline tartrate	31722-678
Leading Pharma LLC	varenicline tartrate	69315-402
>Company	>Ingredient	>NDC

Excipient focus: CROSCARMELLOSE SODIUM

varenicline tartrate drug variants containing CROSCARMELLOSE SODIUM

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Company	Ingredient	NDC
Pfizer Laboratories Div Pfizer Inc	varenicline tartrate	0069-0468
Major Pharmaceuticals	varenicline tartrate	0904-7413
Rebel Distributors Corp	varenicline tartrate	21695-633
Ajanta Pharma USA Inc	varenicline tartrate	27241-173
Camber Pharmaceuticals Inc	varenicline tartrate	31722-678
AvKARE	varenicline tartrate	42291-927
>Company	>Ingredient	>NDC

varenicline tartrate drug variants not containing CROSCARMELLOSE SODIUM

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Company	Ingredient	NDC
>Company	>Ingredient	>NDC

Excipient focus: FD&C BLUE NO. 2

varenicline tartrate drug variants containing FD&C BLUE NO. 2

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Company	Ingredient	NDC
Pfizer Laboratories Div Pfizer Inc	varenicline tartrate	0069-0468
Aphena Pharma Solutions - Tennessee LLC	varenicline tartrate	43353-899
A-S Medication Solutions	varenicline tartrate	50090-0995
A-S Medication Solutions	varenicline tartrate	50090-4481
A-S Medication Solutions	varenicline tartrate	50090-4482
American Health Packaging	varenicline tartrate	60687-648
>Company	>Ingredient	>NDC

varenicline tartrate drug variants not containing FD&C BLUE NO. 2

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Company	Ingredient	NDC
Major Pharmaceuticals	varenicline tartrate	0904-7413
Rebel Distributors Corp	varenicline tartrate	21695-633
Ajanta Pharma USA Inc	varenicline tartrate	27241-173
Camber Pharmaceuticals Inc	varenicline tartrate	31722-678
AvKARE	varenicline tartrate	42291-927
Medley Pharmaceuticals Limited	varenicline tartrate	42934-104
>Company	>Ingredient	>NDC

Excipient focus: FERRIC OXIDE RED

varenicline tartrate drug variants containing FERRIC OXIDE RED

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Company	Ingredient	NDC
Camber Pharmaceuticals Inc	varenicline tartrate	31722-678
>Company	>Ingredient	>NDC

varenicline tartrate drug variants not containing FERRIC OXIDE RED

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Company	Ingredient	NDC
Pfizer Laboratories Div Pfizer Inc	varenicline tartrate	0069-0468
Major Pharmaceuticals	varenicline tartrate	0904-7413
Rebel Distributors Corp	varenicline tartrate	21695-633
Ajanta Pharma USA Inc	varenicline tartrate	27241-173
AvKARE	varenicline tartrate	42291-927
Medley Pharmaceuticals Limited	varenicline tartrate	42934-104
>Company	>Ingredient	>NDC

Excipient focus: FERRIC OXIDE YELLOW

varenicline tartrate drug variants containing FERRIC OXIDE YELLOW

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Company	Ingredient	NDC
Camber Pharmaceuticals Inc	varenicline tartrate	31722-678
American Health Packaging	varenicline tartrate	60687-648
>Company	>Ingredient	>NDC

varenicline tartrate drug variants not containing FERRIC OXIDE YELLOW

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Company	Ingredient	NDC
Pfizer Laboratories Div Pfizer Inc	varenicline tartrate	0069-0468
Major Pharmaceuticals	varenicline tartrate	0904-7413
Rebel Distributors Corp	varenicline tartrate	21695-633
Ajanta Pharma USA Inc	varenicline tartrate	27241-173
AvKARE	varenicline tartrate	42291-927
Medley Pharmaceuticals Limited	varenicline tartrate	42934-104
>Company	>Ingredient	>NDC

Excipient focus: HYDROXYPROPYL CELLULOSE

varenicline tartrate drug variants containing HYDROXYPROPYL CELLULOSE

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Company	Ingredient	NDC
Par Pharmaceutical Inc	varenicline tartrate	49884-155
American Health Packaging	varenicline tartrate	60687-648
Glenmark Pharmaceuticals Inc USA	varenicline tartrate	68462-893
>Company	>Ingredient	>NDC

varenicline tartrate drug variants not containing HYDROXYPROPYL CELLULOSE

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Company	Ingredient	NDC
Pfizer Laboratories Div Pfizer Inc	varenicline tartrate	0069-0468
Major Pharmaceuticals	varenicline tartrate	0904-7413
Rebel Distributors Corp	varenicline tartrate	21695-633
Ajanta Pharma USA Inc	varenicline tartrate	27241-173
Camber Pharmaceuticals Inc	varenicline tartrate	31722-678
AvKARE	varenicline tartrate	42291-927
>Company	>Ingredient	>NDC

Excipient focus: HYPROMELLOSE

varenicline tartrate drug variants containing HYPROMELLOSE

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Company	Ingredient	NDC
Pfizer Laboratories Div Pfizer Inc	varenicline tartrate	0069-0468
Ajanta Pharma USA Inc	varenicline tartrate	27241-173
Aphena Pharma Solutions - Tennessee LLC	varenicline tartrate	43353-899
A-S Medication Solutions	varenicline tartrate	50090-0995
A-S Medication Solutions	varenicline tartrate	50090-4481
A-S Medication Solutions	varenicline tartrate	50090-4482
>Company	>Ingredient	>NDC

varenicline tartrate drug variants not containing HYPROMELLOSE

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Company	Ingredient	NDC
Major Pharmaceuticals	varenicline tartrate	0904-7413
Rebel Distributors Corp	varenicline tartrate	21695-633
Camber Pharmaceuticals Inc	varenicline tartrate	31722-678
AvKARE	varenicline tartrate	42291-927
Medley Pharmaceuticals Limited	varenicline tartrate	42934-104
Par Pharmaceutical Inc	varenicline tartrate	49884-155
>Company	>Ingredient	>NDC

Excipient focus: HYPROMELLOSE 2910

varenicline tartrate drug variants containing HYPROMELLOSE 2910

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Company	Ingredient	NDC
Major Pharmaceuticals	varenicline tartrate	0904-7413
Camber Pharmaceuticals Inc	varenicline tartrate	31722-678
AvKARE	varenicline tartrate	42291-927
Medley Pharmaceuticals Limited	varenicline tartrate	42934-104
Par Pharmaceutical Inc	varenicline tartrate	49884-155
American Health Packaging	varenicline tartrate	60687-648
>Company	>Ingredient	>NDC

varenicline tartrate drug variants not containing HYPROMELLOSE 2910

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Company	Ingredient	NDC
Pfizer Laboratories Div Pfizer Inc	varenicline tartrate	0069-0468
Rebel Distributors Corp	varenicline tartrate	21695-633
Ajanta Pharma USA Inc	varenicline tartrate	27241-173
Aphena Pharma Solutions - Tennessee LLC	varenicline tartrate	43353-899
A-S Medication Solutions	varenicline tartrate	50090-0995
A-S Medication Solutions	varenicline tartrate	50090-4481
>Company	>Ingredient	>NDC

Excipient focus: HYPROMELLOSES

varenicline tartrate drug variants containing HYPROMELLOSES

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Company	Ingredient	NDC
Carilion Materials Management	varenicline tartrate	68151-4952
Carilion Materials Management	varenicline tartrate	68151-4953
AVALANCHE PHARMACEUTICAL LLC	varenicline tartrate	82582-485
>Company	>Ingredient	>NDC

varenicline tartrate drug variants not containing HYPROMELLOSES

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Company	Ingredient	NDC
Pfizer Laboratories Div Pfizer Inc	varenicline tartrate	0069-0468
Major Pharmaceuticals	varenicline tartrate	0904-7413
Rebel Distributors Corp	varenicline tartrate	21695-633
Ajanta Pharma USA Inc	varenicline tartrate	27241-173
Camber Pharmaceuticals Inc	varenicline tartrate	31722-678
AvKARE	varenicline tartrate	42291-927
>Company	>Ingredient	>NDC

Excipient focus: MAGNESIUM STEARATE

varenicline tartrate drug variants containing MAGNESIUM STEARATE

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Company	Ingredient	NDC
Pfizer Laboratories Div Pfizer Inc	varenicline tartrate	0069-0468
Rebel Distributors Corp	varenicline tartrate	21695-633
Ajanta Pharma USA Inc	varenicline tartrate	27241-173
AvKARE	varenicline tartrate	42291-927
Medley Pharmaceuticals Limited	varenicline tartrate	42934-104
Aphena Pharma Solutions - Tennessee LLC	varenicline tartrate	43353-899
>Company	>Ingredient	>NDC

varenicline tartrate drug variants not containing MAGNESIUM STEARATE

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Company	Ingredient	NDC
Major Pharmaceuticals	varenicline tartrate	0904-7413
Camber Pharmaceuticals Inc	varenicline tartrate	31722-678
Par Pharmaceutical Inc	varenicline tartrate	49884-155
American Health Packaging	varenicline tartrate	60687-648
>Company	>Ingredient	>NDC

Excipient focus: MALTODEXTRIN

varenicline tartrate drug variants containing MALTODEXTRIN

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Company	Ingredient	NDC
Major Pharmaceuticals	varenicline tartrate	0904-7413
Ajanta Pharma USA Inc	varenicline tartrate	27241-173
Medley Pharmaceuticals Limited	varenicline tartrate	42934-104
Par Pharmaceutical Inc	varenicline tartrate	49884-155
American Health Packaging	varenicline tartrate	60687-648
Glenmark Pharmaceuticals Inc USA	varenicline tartrate	68462-893
>Company	>Ingredient	>NDC

varenicline tartrate drug variants not containing MALTODEXTRIN

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Company	Ingredient	NDC
Pfizer Laboratories Div Pfizer Inc	varenicline tartrate	0069-0468
Rebel Distributors Corp	varenicline tartrate	21695-633
Camber Pharmaceuticals Inc	varenicline tartrate	31722-678
AvKARE	varenicline tartrate	42291-927
Aphena Pharma Solutions - Tennessee LLC	varenicline tartrate	43353-899
A-S Medication Solutions	varenicline tartrate	50090-0995
>Company	>Ingredient	>NDC

Excipient focus: MICROCRYSTALLINE CELLULOSE 302

varenicline tartrate drug variants containing MICROCRYSTALLINE CELLULOSE 302

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Company	Ingredient	NDC
Leading Pharma LLC	varenicline tartrate	69315-402
>Company	>Ingredient	>NDC

varenicline tartrate drug variants not containing MICROCRYSTALLINE CELLULOSE 302

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Company	Ingredient	NDC
Pfizer Laboratories Div Pfizer Inc	varenicline tartrate	0069-0468
Major Pharmaceuticals	varenicline tartrate	0904-7413
Rebel Distributors Corp	varenicline tartrate	21695-633
Ajanta Pharma USA Inc	varenicline tartrate	27241-173
Camber Pharmaceuticals Inc	varenicline tartrate	31722-678
AvKARE	varenicline tartrate	42291-927
>Company	>Ingredient	>NDC

Excipient focus: POLYETHYLENE GLYCOL

varenicline tartrate drug variants containing POLYETHYLENE GLYCOL

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Company	Ingredient	NDC
Pfizer Laboratories Div Pfizer Inc	varenicline tartrate	0069-0468
Major Pharmaceuticals	varenicline tartrate	0904-7413
Ajanta Pharma USA Inc	varenicline tartrate	27241-173
AvKARE	varenicline tartrate	42291-927
Aphena Pharma Solutions - Tennessee LLC	varenicline tartrate	43353-899
A-S Medication Solutions	varenicline tartrate	50090-0995
>Company	>Ingredient	>NDC

varenicline tartrate drug variants not containing POLYETHYLENE GLYCOL

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Company	Ingredient	NDC
Rebel Distributors Corp	varenicline tartrate	21695-633
Camber Pharmaceuticals Inc	varenicline tartrate	31722-678
Medley Pharmaceuticals Limited	varenicline tartrate	42934-104
Par Pharmaceutical Inc	varenicline tartrate	49884-155
American Health Packaging	varenicline tartrate	60687-648
Carilion Materials Management	varenicline tartrate	68151-4952
>Company	>Ingredient	>NDC

Excipient focus: POLYETHYLENE GLYCOL 400

varenicline tartrate drug variants containing POLYETHYLENE GLYCOL 400

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Company	Ingredient	NDC
Camber Pharmaceuticals Inc	varenicline tartrate	31722-678
Medley Pharmaceuticals Limited	varenicline tartrate	42934-104
Leading Pharma LLC	varenicline tartrate	69315-402
>Company	>Ingredient	>NDC

varenicline tartrate drug variants not containing POLYETHYLENE GLYCOL 400

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Company	Ingredient	NDC
Pfizer Laboratories Div Pfizer Inc	varenicline tartrate	0069-0468
Major Pharmaceuticals	varenicline tartrate	0904-7413
Rebel Distributors Corp	varenicline tartrate	21695-633
Ajanta Pharma USA Inc	varenicline tartrate	27241-173
AvKARE	varenicline tartrate	42291-927
Aphena Pharma Solutions - Tennessee LLC	varenicline tartrate	43353-899
>Company	>Ingredient	>NDC

Excipient focus: POLYETHYLENE GLYCOLS

varenicline tartrate drug variants containing POLYETHYLENE GLYCOLS

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Company	Ingredient	NDC
Carilion Materials Management	varenicline tartrate	68151-4952
Carilion Materials Management	varenicline tartrate	68151-4953
>Company	>Ingredient	>NDC

varenicline tartrate drug variants not containing POLYETHYLENE GLYCOLS

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Company	Ingredient	NDC
Pfizer Laboratories Div Pfizer Inc	varenicline tartrate	0069-0468
Major Pharmaceuticals	varenicline tartrate	0904-7413
Rebel Distributors Corp	varenicline tartrate	21695-633
Ajanta Pharma USA Inc	varenicline tartrate	27241-173
Camber Pharmaceuticals Inc	varenicline tartrate	31722-678
AvKARE	varenicline tartrate	42291-927
>Company	>Ingredient	>NDC

Excipient focus: SILICON DIOXIDE

varenicline tartrate drug variants containing SILICON DIOXIDE

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Company	Ingredient	NDC
Pfizer Laboratories Div Pfizer Inc	varenicline tartrate	0069-0468
Rebel Distributors Corp	varenicline tartrate	21695-633
Ajanta Pharma USA Inc	varenicline tartrate	27241-173
AvKARE	varenicline tartrate	42291-927
Medley Pharmaceuticals Limited	varenicline tartrate	42934-104
Aphena Pharma Solutions - Tennessee LLC	varenicline tartrate	43353-899
>Company	>Ingredient	>NDC

varenicline tartrate drug variants not containing SILICON DIOXIDE

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Company	Ingredient	NDC
Major Pharmaceuticals	varenicline tartrate	0904-7413
Camber Pharmaceuticals Inc	varenicline tartrate	31722-678
Par Pharmaceutical Inc	varenicline tartrate	49884-155
American Health Packaging	varenicline tartrate	60687-648
>Company	>Ingredient	>NDC

Excipient focus: STEARIC ACID

varenicline tartrate drug variants containing STEARIC ACID

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Company	Ingredient	NDC
Major Pharmaceuticals	varenicline tartrate	0904-7413
Camber Pharmaceuticals Inc	varenicline tartrate	31722-678
Par Pharmaceutical Inc	varenicline tartrate	49884-155
American Health Packaging	varenicline tartrate	60687-648
>Company	>Ingredient	>NDC

varenicline tartrate drug variants not containing STEARIC ACID

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Company	Ingredient	NDC
Pfizer Laboratories Div Pfizer Inc	varenicline tartrate	0069-0468
Rebel Distributors Corp	varenicline tartrate	21695-633
Ajanta Pharma USA Inc	varenicline tartrate	27241-173
AvKARE	varenicline tartrate	42291-927
Medley Pharmaceuticals Limited	varenicline tartrate	42934-104
Aphena Pharma Solutions - Tennessee LLC	varenicline tartrate	43353-899
>Company	>Ingredient	>NDC

Excipient focus: TALC

varenicline tartrate drug variants containing TALC

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Company	Ingredient	NDC
Par Pharmaceutical Inc	varenicline tartrate	49884-155
American Health Packaging	varenicline tartrate	60687-648
>Company	>Ingredient	>NDC

varenicline tartrate drug variants not containing TALC

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Company	Ingredient	NDC
Pfizer Laboratories Div Pfizer Inc	varenicline tartrate	0069-0468
Major Pharmaceuticals	varenicline tartrate	0904-7413
Rebel Distributors Corp	varenicline tartrate	21695-633
Ajanta Pharma USA Inc	varenicline tartrate	27241-173
Camber Pharmaceuticals Inc	varenicline tartrate	31722-678
AvKARE	varenicline tartrate	42291-927
>Company	>Ingredient	>NDC

Excipient focus: TITANIUM DIOXIDE

varenicline tartrate drug variants containing TITANIUM DIOXIDE

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Company	Ingredient	NDC
Pfizer Laboratories Div Pfizer Inc	varenicline tartrate	0069-0468
Major Pharmaceuticals	varenicline tartrate	0904-7413
Ajanta Pharma USA Inc	varenicline tartrate	27241-173
Camber Pharmaceuticals Inc	varenicline tartrate	31722-678
AvKARE	varenicline tartrate	42291-927
Medley Pharmaceuticals Limited	varenicline tartrate	42934-104
>Company	>Ingredient	>NDC

varenicline tartrate drug variants not containing TITANIUM DIOXIDE

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Company	Ingredient	NDC
Rebel Distributors Corp	varenicline tartrate	21695-633
>Company	>Ingredient	>NDC

Excipient focus: TRIACETIN

varenicline tartrate drug variants containing TRIACETIN

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Company	Ingredient	NDC
Pfizer Laboratories Div Pfizer Inc	varenicline tartrate	0069-0468
Major Pharmaceuticals	varenicline tartrate	0904-7413
Camber Pharmaceuticals Inc	varenicline tartrate	31722-678
AvKARE	varenicline tartrate	42291-927
Medley Pharmaceuticals Limited	varenicline tartrate	42934-104
A-S Medication Solutions	varenicline tartrate	50090-4481
>Company	>Ingredient	>NDC

varenicline tartrate drug variants not containing TRIACETIN

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Company	Ingredient	NDC
Rebel Distributors Corp	varenicline tartrate	21695-633
Ajanta Pharma USA Inc	varenicline tartrate	27241-173
Aphena Pharma Solutions - Tennessee LLC	varenicline tartrate	43353-899
Par Pharmaceutical Inc	varenicline tartrate	49884-155
A-S Medication Solutions	varenicline tartrate	50090-0995
A-S Medication Solutions	varenicline tartrate	50090-4482
>Company	>Ingredient	>NDC

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