List of Excipients in API varenicline
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Excipients in NDA-approved (novel) drugs containing varenicline
| Company | Tradename | Ingredient | NDC | Excipient | Potential Generic Entry |
|---|---|---|---|---|---|
| Oyster Point Pharma | TYRVAYA | varenicline | 73521-030 | HYDROCHLORIC ACID | |
| Oyster Point Pharma | TYRVAYA | varenicline | 73521-030 | SODIUM CHLORIDE | |
| Oyster Point Pharma | TYRVAYA | varenicline | 73521-030 | SODIUM HYDROXIDE | |
| Oyster Point Pharma | TYRVAYA | varenicline | 73521-030 | SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE | |
| Oyster Point Pharma | TYRVAYA | varenicline | 73521-030 | SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS | |
| Oyster Point Pharma | TYRVAYA | varenicline | 73521-030 | WATER | |
| Pfizer Laboratories Div Pfizer Inc | CHANTIX | varenicline tartrate | 0069-0468 | ANHYDROUS DIBASIC CALCIUM PHOSPHATE | |
| >Company | >Tradename | >Ingredient | >NDC | >Excipient | >Potential Generic Entry |
Excipients in ANDA-approved (generic) drugs containing varenicline
Detailed excipient profiles for varenicline
Excipient focus: ANHYDROUS DIBASIC CALCIUM PHOSPHATE
varenicline drug variants containing ANHYDROUS DIBASIC CALCIUM PHOSPHATE
varenicline drug variants not containing ANHYDROUS DIBASIC CALCIUM PHOSPHATE
Excipient focus: BUTYLATED HYDROXYANISOLE
varenicline drug variants containing BUTYLATED HYDROXYANISOLE
| Company | Ingredient | NDC |
|---|---|---|
| Glenmark Pharmaceuticals Inc USA | varenicline tartrate | 68462-893 |
| >Company | >Ingredient | >NDC |
varenicline drug variants not containing BUTYLATED HYDROXYANISOLE
Excipient focus: CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS
varenicline drug variants containing CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS
| 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 drug variants not containing CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS
Excipient focus: CELLULOSE, MICROCRYSTALLINE
varenicline drug variants containing CELLULOSE, MICROCRYSTALLINE
varenicline drug variants not containing CELLULOSE, MICROCRYSTALLINE
Excipient focus: CROSCARMELLOSE SODIUM
varenicline drug variants containing CROSCARMELLOSE SODIUM
varenicline drug variants not containing CROSCARMELLOSE SODIUM
| Company | Ingredient | NDC |
|---|---|---|
| Oyster Point Pharma | varenicline | 73521-030 |
| >Company | >Ingredient | >NDC |
Excipient focus: FD&C BLUE NO. 2
varenicline drug variants containing FD&C BLUE NO. 2
varenicline drug variants not containing FD&C BLUE NO. 2
Excipient focus: FERRIC OXIDE RED
varenicline drug variants containing FERRIC OXIDE RED
| Company | Ingredient | NDC |
|---|---|---|
| Camber Pharmaceuticals Inc | varenicline tartrate | 31722-678 |
| >Company | >Ingredient | >NDC |
varenicline drug variants not containing FERRIC OXIDE RED
Excipient focus: FERRIC OXIDE YELLOW
varenicline drug variants containing FERRIC OXIDE YELLOW
| Company | Ingredient | NDC |
|---|---|---|
| Lupin Pharmaceuticals Inc | varenicline | 70748-126 |
| Camber Pharmaceuticals Inc | varenicline tartrate | 31722-678 |
| American Health Packaging | varenicline tartrate | 60687-648 |
| >Company | >Ingredient | >NDC |
varenicline drug variants not containing FERRIC OXIDE YELLOW
Excipient focus: GLYCERYL DIBEHENATE
varenicline drug variants containing GLYCERYL DIBEHENATE
| Company | Ingredient | NDC |
|---|---|---|
| Mylan Pharmaceuticals Inc | varenicline | 0378-5089 |
| >Company | >Ingredient | >NDC |
varenicline drug variants not containing GLYCERYL DIBEHENATE
Excipient focus: HYDROCHLORIC ACID
varenicline drug variants containing HYDROCHLORIC ACID
| Company | Ingredient | NDC |
|---|---|---|
| Oyster Point Pharma | varenicline | 73521-030 |
| >Company | >Ingredient | >NDC |
varenicline drug variants not containing HYDROCHLORIC ACID
Excipient focus: HYDROXYPROPYL CELLULOSE
varenicline drug variants containing HYDROXYPROPYL CELLULOSE
varenicline drug variants not containing HYDROXYPROPYL CELLULOSE
Excipient focus: HYPROMELLOSE
varenicline drug variants containing HYPROMELLOSE
varenicline drug variants not containing HYPROMELLOSE
Excipient focus: HYPROMELLOSE 2910
varenicline drug variants containing HYPROMELLOSE 2910
varenicline drug variants not containing HYPROMELLOSE 2910
Excipient focus: HYPROMELLOSES
varenicline drug variants containing HYPROMELLOSES
| 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 drug variants not containing HYPROMELLOSES
Excipient focus: MAGNESIUM STEARATE
varenicline drug variants containing MAGNESIUM STEARATE
varenicline drug variants not containing MAGNESIUM STEARATE
Excipient focus: MALTODEXTRIN
varenicline drug variants containing MALTODEXTRIN
varenicline drug variants not containing MALTODEXTRIN
Excipient focus: MANNITOL
varenicline drug variants containing MANNITOL
| Company | Ingredient | NDC |
|---|---|---|
| Mylan Pharmaceuticals Inc | varenicline | 0378-5089 |
| >Company | >Ingredient | >NDC |
varenicline drug variants not containing MANNITOL
Excipient focus: MICROCRYSTALLINE CELLULOSE 302
varenicline drug variants containing MICROCRYSTALLINE CELLULOSE 302
| Company | Ingredient | NDC |
|---|---|---|
| Leading Pharma LLC | varenicline tartrate | 69315-402 |
| >Company | >Ingredient | >NDC |
varenicline drug variants not containing MICROCRYSTALLINE CELLULOSE 302
Excipient focus: POLYETHYLENE GLYCOL
varenicline drug variants containing POLYETHYLENE GLYCOL
varenicline drug variants not containing POLYETHYLENE GLYCOL
Excipient focus: POLYETHYLENE GLYCOL 400
varenicline drug variants containing POLYETHYLENE GLYCOL 400
| 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 drug variants not containing POLYETHYLENE GLYCOL 400
Excipient focus: POLYETHYLENE GLYCOLS
varenicline drug variants containing POLYETHYLENE GLYCOLS
| Company | Ingredient | NDC |
|---|---|---|
| Carilion Materials Management | varenicline tartrate | 68151-4952 |
| Carilion Materials Management | varenicline tartrate | 68151-4953 |
| >Company | >Ingredient | >NDC |
varenicline drug variants not containing POLYETHYLENE GLYCOLS
Excipient focus: SILICON DIOXIDE
varenicline drug variants containing SILICON DIOXIDE
varenicline drug variants not containing SILICON DIOXIDE
Excipient focus: SODIUM CHLORIDE
varenicline drug variants containing SODIUM CHLORIDE
| Company | Ingredient | NDC |
|---|---|---|
| Oyster Point Pharma | varenicline | 73521-030 |
| >Company | >Ingredient | >NDC |
varenicline drug variants not containing SODIUM CHLORIDE
Excipient focus: SODIUM HYDROXIDE
varenicline drug variants containing SODIUM HYDROXIDE
| Company | Ingredient | NDC |
|---|---|---|
| Oyster Point Pharma | varenicline | 73521-030 |
| >Company | >Ingredient | >NDC |
varenicline drug variants not containing SODIUM HYDROXIDE
Excipient focus: SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE
varenicline drug variants containing SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE
| Company | Ingredient | NDC |
|---|---|---|
| Oyster Point Pharma | varenicline | 73521-030 |
| >Company | >Ingredient | >NDC |
varenicline drug variants not containing SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE
Excipient focus: SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS
varenicline drug variants containing SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS
| Company | Ingredient | NDC |
|---|---|---|
| Oyster Point Pharma | varenicline | 73521-030 |
| >Company | >Ingredient | >NDC |
varenicline drug variants not containing SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS
Excipient focus: SODIUM STEARYL FUMARATE
varenicline drug variants containing SODIUM STEARYL FUMARATE
| Company | Ingredient | NDC |
|---|---|---|
| A-S Medication Solutions | varenicline | 50090-6446 |
| A-S Medication Solutions | varenicline | 50090-6447 |
| Golden State Medical Supply Inc | varenicline | 51407-755 |
| Apotex Corp | varenicline | 60505-3613 |
| Bryant Ranch Prepack | varenicline | 72162-2218 |
| Bryant Ranch Prepack | varenicline | 72162-2219 |
| >Company | >Ingredient | >NDC |
varenicline drug variants not containing SODIUM STEARYL FUMARATE
Excipient focus: STEARIC ACID
varenicline drug variants containing STEARIC ACID
| 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 drug variants not containing STEARIC ACID
Excipient focus: TALC
varenicline drug variants containing TALC
| Company | Ingredient | NDC |
|---|---|---|
| Lupin Pharmaceuticals Inc | varenicline | 70748-126 |
| Par Pharmaceutical Inc | varenicline tartrate | 49884-155 |
| American Health Packaging | varenicline tartrate | 60687-648 |
| >Company | >Ingredient | >NDC |
varenicline drug variants not containing TALC
Excipient focus: TITANIUM DIOXIDE
varenicline drug variants containing TITANIUM DIOXIDE
varenicline drug variants not containing TITANIUM DIOXIDE
| Company | Ingredient | NDC |
|---|---|---|
| Oyster Point Pharma | varenicline | 73521-030 |
| Rebel Distributors Corp | varenicline tartrate | 21695-633 |
| >Company | >Ingredient | >NDC |
Excipient focus: TRIACETIN
varenicline drug variants containing TRIACETIN
varenicline drug variants not containing TRIACETIN
Excipient focus: WATER
varenicline drug variants containing WATER
| Company | Ingredient | NDC |
|---|---|---|
| Oyster Point Pharma | varenicline | 73521-030 |
| >Company | >Ingredient | >NDC |
varenicline drug variants not containing WATER
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ISSN: 2162-2639
Privacy and Cookies
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DrugPatentWatch Alternatives
LOE / Generic Entry Opportunies 2024 - 2025
NCE-1 Patent Challenge Dates 2024 - 2025
Trigger-based marketing for the life sciences
Get DrugPatentWatch Business Intelligence Reports at Amazon.com
DrugChatter - AI-based answers to questions about drugs
RxJam - HIPAA-ready chat for life sciences
Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2024, www.DrugPatentWatch.com.
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