List of Excipients in API palonosetron

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Excipients in NDA-approved (novel) drugs containing palonosetron

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Company	Tradename	Ingredient	NDC	Excipient	Potential Generic Entry
Avyxa Pharma LLC	POSFREA	palonosetron	83831-105	MANNITOL
Avyxa Pharma LLC	POSFREA	palonosetron	83831-105	SODIUM ACETATE
Avyxa Pharma LLC	POSFREA	palonosetron	83831-105	WATER
>Company	>Tradename	>Ingredient	>NDC	>Excipient	>Potential Generic Entry

Excipients in ANDA-approved (generic) drugs containing palonosetron

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Company	Ingredient	NDC	Excipient
NorthStar Rx LLC	palonosetron	16714-834	EDETATE DISODIUM
NorthStar Rx LLC	palonosetron	16714-834	MANNITOL
NorthStar Rx LLC	palonosetron	16714-834	SODIUM ACETATE
>Company	>Ingredient	>NDC	>Excipient

Detailed excipient profiles for palonosetron

Excipient focus: ANHYDROUS CITRIC ACID

palonosetron drug variants containing ANHYDROUS CITRIC ACID

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Company	Ingredient	NDC
Fresenius Kabi USA LLC	palonosetron	63323-673
>Company	>Ingredient	>NDC

palonosetron drug variants not containing ANHYDROUS CITRIC ACID

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Company	Ingredient	NDC
NorthStar Rx LLC	palonosetron	16714-834
DrReddy's Laboratories Limited	palonosetron	55111-694
BluePoint Laboratories	palonosetron	68001-355
>Company	>Ingredient	>NDC

Excipient focus: BUTYLATED HYDROXYANISOLE

palonosetron drug variants containing BUTYLATED HYDROXYANISOLE

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Company	Ingredient	NDC
Helsinn Therapeutics (US) Inc	palonosetron hydrochloride	69639-104
>Company	>Ingredient	>NDC

palonosetron drug variants not containing BUTYLATED HYDROXYANISOLE

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Company	Ingredient	NDC
NorthStar Rx LLC	palonosetron	16714-834
DrReddy's Laboratories Limited	palonosetron	55111-694
Fresenius Kabi USA LLC	palonosetron	63323-673
>Company	>Ingredient	>NDC

Excipient focus: CAPRYLIC/CAPRIC MONO/DI-GLYCERIDES

palonosetron drug variants containing CAPRYLIC/CAPRIC MONO/DI-GLYCERIDES

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Company	Ingredient	NDC
Helsinn Therapeutics (US) Inc	palonosetron hydrochloride	69639-104
>Company	>Ingredient	>NDC

palonosetron drug variants not containing CAPRYLIC/CAPRIC MONO/DI-GLYCERIDES

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Company	Ingredient	NDC
NorthStar Rx LLC	palonosetron	16714-834
DrReddy's Laboratories Limited	palonosetron	55111-694
Fresenius Kabi USA LLC	palonosetron	63323-673
>Company	>Ingredient	>NDC

Excipient focus: CITRIC ACID MONOHYDRATE

palonosetron drug variants containing CITRIC ACID MONOHYDRATE

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Company	Ingredient	NDC
Hospira Inc	palonosetron hydrochloride	0409-2503
Teva Parenteral Medicines Inc	palonosetron hydrochloride	0703-4094
Sandoz Inc	palonosetron hydrochloride	0781-3312
>Company	>Ingredient	>NDC

palonosetron drug variants not containing CITRIC ACID MONOHYDRATE

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Company	Ingredient	NDC
NorthStar Rx LLC	palonosetron	16714-834
DrReddy's Laboratories Limited	palonosetron	55111-694
Fresenius Kabi USA LLC	palonosetron	63323-673
>Company	>Ingredient	>NDC

Excipient focus: EDETATE DISODIUM

palonosetron drug variants containing EDETATE DISODIUM

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Company	Ingredient	NDC
NorthStar Rx LLC	palonosetron	16714-834
DrReddy's Laboratories Limited	palonosetron	55111-694
Fresenius Kabi USA LLC	palonosetron	63323-673
>Company	>Ingredient	>NDC

palonosetron drug variants not containing EDETATE DISODIUM

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Company	Ingredient	NDC
Avyxa Pharma LLC	palonosetron	83831-105
Apotex Corp	palonosetron hydrochloride	60505-6193
Apotex Corp	palonosetron hydrochloride	60505-6439
>Company	>Ingredient	>NDC

Excipient focus: GLYCERIN

palonosetron drug variants containing GLYCERIN

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Company	Ingredient	NDC
Helsinn Therapeutics (US) Inc	palonosetron hydrochloride	69639-104
>Company	>Ingredient	>NDC

palonosetron drug variants not containing GLYCERIN

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Company	Ingredient	NDC
NorthStar Rx LLC	palonosetron	16714-834
DrReddy's Laboratories Limited	palonosetron	55111-694
Fresenius Kabi USA LLC	palonosetron	63323-673
>Company	>Ingredient	>NDC

Excipient focus: GLYCINE

palonosetron drug variants containing GLYCINE

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Company	Ingredient	NDC
Ingenus Pharmaceuticals LLC	palonosetron hydrochloride	50742-485
>Company	>Ingredient	>NDC

palonosetron drug variants not containing GLYCINE

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Company	Ingredient	NDC
NorthStar Rx LLC	palonosetron	16714-834
DrReddy's Laboratories Limited	palonosetron	55111-694
Fresenius Kabi USA LLC	palonosetron	63323-673
>Company	>Ingredient	>NDC

Excipient focus: HYDROCHLORIC ACID

palonosetron drug variants containing HYDROCHLORIC ACID

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Company	Ingredient	NDC
Fresenius Kabi USA LLC	palonosetron	63323-673
Hospira Inc	palonosetron hydrochloride	0409-2503
Teva Parenteral Medicines Inc	palonosetron hydrochloride	0703-4094
>Company	>Ingredient	>NDC

palonosetron drug variants not containing HYDROCHLORIC ACID

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Company	Ingredient	NDC
NorthStar Rx LLC	palonosetron	16714-834
DrReddy's Laboratories Limited	palonosetron	55111-694
BluePoint Laboratories	palonosetron	68001-355
>Company	>Ingredient	>NDC

Excipient focus: MANNITOL

palonosetron drug variants containing MANNITOL

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Company	Ingredient	NDC
NorthStar Rx LLC	palonosetron	16714-834
DrReddy's Laboratories Limited	palonosetron	55111-694
Fresenius Kabi USA LLC	palonosetron	63323-673
>Company	>Ingredient	>NDC

palonosetron drug variants not containing MANNITOL

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Company	Ingredient	NDC
Helsinn Therapeutics (US) Inc	palonosetron hydrochloride	69639-104
>Company	>Ingredient	>NDC

Excipient focus: POLYGLYCERYL-10 OLEATE

palonosetron drug variants containing POLYGLYCERYL-10 OLEATE

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Company	Ingredient	NDC
Helsinn Therapeutics (US) Inc	palonosetron hydrochloride	69639-104
>Company	>Ingredient	>NDC

palonosetron drug variants not containing POLYGLYCERYL-10 OLEATE

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Company	Ingredient	NDC
NorthStar Rx LLC	palonosetron	16714-834
DrReddy's Laboratories Limited	palonosetron	55111-694
Fresenius Kabi USA LLC	palonosetron	63323-673
>Company	>Ingredient	>NDC

Excipient focus: SODIUM ACETATE

palonosetron drug variants containing SODIUM ACETATE

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Company	Ingredient	NDC
NorthStar Rx LLC	palonosetron	16714-834
DrReddy's Laboratories Limited	palonosetron	55111-694
BluePoint Laboratories	palonosetron	68001-355
>Company	>Ingredient	>NDC

palonosetron drug variants not containing SODIUM ACETATE

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Company	Ingredient	NDC
Fresenius Kabi USA LLC	palonosetron	63323-673
Hospira Inc	palonosetron hydrochloride	0409-2503
Teva Parenteral Medicines Inc	palonosetron hydrochloride	0703-4094
>Company	>Ingredient	>NDC

Excipient focus: SODIUM CITRATE

palonosetron drug variants containing SODIUM CITRATE

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Company	Ingredient	NDC
Accord Healthcare Inc	palonosetron hydrochloride	16729-365
Heritage Pharmaceuticals Inc d/b/a Avet Pharmaceuticals Inc	palonosetron hydrochloride	23155-356
Baxter Healthcare Corporation	palonosetron hydrochloride	36000-326
>Company	>Ingredient	>NDC

palonosetron drug variants not containing SODIUM CITRATE

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Company	Ingredient	NDC
NorthStar Rx LLC	palonosetron	16714-834
DrReddy's Laboratories Limited	palonosetron	55111-694
Fresenius Kabi USA LLC	palonosetron	63323-673
>Company	>Ingredient	>NDC

Excipient focus: SODIUM HYDROXIDE

palonosetron drug variants containing SODIUM HYDROXIDE

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Company	Ingredient	NDC
Fresenius Kabi USA LLC	palonosetron	63323-673
Hospira Inc	palonosetron hydrochloride	0409-2503
Teva Parenteral Medicines Inc	palonosetron hydrochloride	0703-4094
>Company	>Ingredient	>NDC

palonosetron drug variants not containing SODIUM HYDROXIDE

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Company	Ingredient	NDC
NorthStar Rx LLC	palonosetron	16714-834
DrReddy's Laboratories Limited	palonosetron	55111-694
BluePoint Laboratories	palonosetron	68001-355
>Company	>Ingredient	>NDC

Excipient focus: TRISODIUM CITRATE DIHYDRATE

palonosetron drug variants containing TRISODIUM CITRATE DIHYDRATE

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Company	Ingredient	NDC
Fresenius Kabi USA LLC	palonosetron	63323-673
Hospira Inc	palonosetron hydrochloride	0409-2503
Teva Parenteral Medicines Inc	palonosetron hydrochloride	0703-4094
>Company	>Ingredient	>NDC

palonosetron drug variants not containing TRISODIUM CITRATE DIHYDRATE

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Company	Ingredient	NDC
NorthStar Rx LLC	palonosetron	16714-834
DrReddy's Laboratories Limited	palonosetron	55111-694
BluePoint Laboratories	palonosetron	68001-355
>Company	>Ingredient	>NDC

Excipient focus: WATER

palonosetron drug variants containing WATER

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Company	Ingredient	NDC
NorthStar Rx LLC	palonosetron	16714-834
DrReddy's Laboratories Limited	palonosetron	55111-694
BluePoint Laboratories	palonosetron	68001-355
>Company	>Ingredient	>NDC

palonosetron drug variants not containing WATER

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Company	Ingredient	NDC
Fresenius Kabi USA LLC	palonosetron	63323-673
Ingenus Pharmaceuticals LLC	palonosetron hydrochloride	50742-485
>Company	>Ingredient	>NDC

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