List of Excipients in API gemcitabine

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Excipients in NDA-approved (novel) drugs containing gemcitabine

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Company	Tradename	Ingredient	NDC	Excipient	Potential Generic Entry
Hospira Inc	GEMCITABINE	gemcitabine	0409-0181	HYDROCHLORIC ACID
Hospira Inc	GEMCITABINE	gemcitabine	0409-0181	SODIUM HYDROXIDE
Hospira Inc	GEMCITABINE	gemcitabine	0409-0181	WATER
>Company	>Tradename	>Ingredient	>NDC	>Excipient	>Potential Generic Entry

Excipients in ANDA-approved (generic) drugs containing gemcitabine

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Company	Ingredient	NDC	Excipient
Hikma Pharmaceuticals USA Inc	gemcitabine	0143-9340	HYDROCHLORIC ACID
Hikma Pharmaceuticals USA Inc	gemcitabine	0143-9340	SODIUM HYDROXIDE
Hikma Pharmaceuticals USA Inc	gemcitabine	0143-9340	WATER
>Company	>Ingredient	>NDC	>Excipient

Detailed excipient profiles for gemcitabine

Excipient focus: ALCOHOL

gemcitabine drug variants containing ALCOHOL

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Company	Ingredient	NDC
Accord Healthcare Inc	gemcitabine	16729-391
BluePoint Laboratories	gemcitabine	68001-342
>Company	>Ingredient	>NDC

gemcitabine drug variants not containing ALCOHOL

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Company	Ingredient	NDC
Hikma Pharmaceuticals USA Inc	gemcitabine	0143-9340
Hikma Pharmaceuticals USA Inc	gemcitabine	0143-9394
Hospira Inc	gemcitabine	0409-0181
>Company	>Ingredient	>NDC

Excipient focus: FD&C BLUE NO. 1

gemcitabine drug variants containing FD&C BLUE NO. 1

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Company	Ingredient	NDC
Janssen Biotech Inc	gemcitabine intravesical	57894-225
>Company	>Ingredient	>NDC

gemcitabine drug variants not containing FD&C BLUE NO. 1

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Company	Ingredient	NDC
Hikma Pharmaceuticals USA Inc	gemcitabine	0143-9340
Hikma Pharmaceuticals USA Inc	gemcitabine	0143-9394
Hospira Inc	gemcitabine	0409-0181
>Company	>Ingredient	>NDC

Excipient focus: HYDROCHLORIC ACID

gemcitabine drug variants containing HYDROCHLORIC ACID

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Company	Ingredient	NDC
Hikma Pharmaceuticals USA Inc	gemcitabine	0143-9340
Hikma Pharmaceuticals USA Inc	gemcitabine	0143-9394
Hospira Inc	gemcitabine	0409-0181
>Company	>Ingredient	>NDC

gemcitabine drug variants not containing HYDROCHLORIC ACID

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Company	Ingredient	NDC
Dr Reddy's Laboratories Limited	gemcitabine	55111-686
Bedford Laboratories	gemcitabine	55390-391
Avyxa Pharma LLC	gemcitabine	83831-122
>Company	>Ingredient	>NDC

Excipient focus: MANNITOL

gemcitabine drug variants containing MANNITOL

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Company	Ingredient	NDC
Hikma Pharmaceuticals USA Inc	gemcitabine	0143-9394
Hospira Inc	gemcitabine	0409-0185
Hospira Inc	gemcitabine	0409-0187
>Company	>Ingredient	>NDC

gemcitabine drug variants not containing MANNITOL

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Company	Ingredient	NDC
Hikma Pharmaceuticals USA Inc	gemcitabine	0143-9340
Hospira Inc	gemcitabine	0409-0181
Accord Healthcare Inc	gemcitabine	16729-391
>Company	>Ingredient	>NDC

Excipient focus: POLYETHYLENE GLYCOL 300

gemcitabine drug variants containing POLYETHYLENE GLYCOL 300

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Company	Ingredient	NDC
Accord Healthcare Inc	gemcitabine	16729-391
BluePoint Laboratories	gemcitabine	68001-342
>Company	>Ingredient	>NDC

gemcitabine drug variants not containing POLYETHYLENE GLYCOL 300

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Company	Ingredient	NDC
Hikma Pharmaceuticals USA Inc	gemcitabine	0143-9340
Hikma Pharmaceuticals USA Inc	gemcitabine	0143-9394
Hospira Inc	gemcitabine	0409-0181
>Company	>Ingredient	>NDC

Excipient focus: POLYETHYLENE GLYCOL 8000

gemcitabine drug variants containing POLYETHYLENE GLYCOL 8000

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Company	Ingredient	NDC
Janssen Biotech Inc	gemcitabine intravesical	57894-225
>Company	>Ingredient	>NDC

gemcitabine drug variants not containing POLYETHYLENE GLYCOL 8000

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Company	Ingredient	NDC
Hikma Pharmaceuticals USA Inc	gemcitabine	0143-9340
Hikma Pharmaceuticals USA Inc	gemcitabine	0143-9394
Hospira Inc	gemcitabine	0409-0181
>Company	>Ingredient	>NDC

Excipient focus: POLYETHYLENE OXIDE 600000

gemcitabine drug variants containing POLYETHYLENE OXIDE 600000

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Company	Ingredient	NDC
Janssen Biotech Inc	gemcitabine intravesical	57894-225
>Company	>Ingredient	>NDC

gemcitabine drug variants not containing POLYETHYLENE OXIDE 600000

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Company	Ingredient	NDC
Hikma Pharmaceuticals USA Inc	gemcitabine	0143-9340
Hikma Pharmaceuticals USA Inc	gemcitabine	0143-9394
Hospira Inc	gemcitabine	0409-0181
>Company	>Ingredient	>NDC

Excipient focus: POVIDONE K30

gemcitabine drug variants containing POVIDONE K30

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Company	Ingredient	NDC
Janssen Biotech Inc	gemcitabine intravesical	57894-225
>Company	>Ingredient	>NDC

gemcitabine drug variants not containing POVIDONE K30

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Company	Ingredient	NDC
Hikma Pharmaceuticals USA Inc	gemcitabine	0143-9340
Hikma Pharmaceuticals USA Inc	gemcitabine	0143-9394
Hospira Inc	gemcitabine	0409-0181
>Company	>Ingredient	>NDC

Excipient focus: PROPYLENE GLYCOL

gemcitabine drug variants containing PROPYLENE GLYCOL

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Company	Ingredient	NDC
Accord Healthcare Inc	gemcitabine	16729-391
BluePoint Laboratories	gemcitabine	68001-342
>Company	>Ingredient	>NDC

gemcitabine drug variants not containing PROPYLENE GLYCOL

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Company	Ingredient	NDC
Hikma Pharmaceuticals USA Inc	gemcitabine	0143-9340
Hikma Pharmaceuticals USA Inc	gemcitabine	0143-9394
Hospira Inc	gemcitabine	0409-0181
>Company	>Ingredient	>NDC

Excipient focus: SODIUM ACETATE

gemcitabine drug variants containing SODIUM ACETATE

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Company	Ingredient	NDC
Hikma Pharmaceuticals USA Inc	gemcitabine	0143-9394
Hospira Inc	gemcitabine	0409-0185
Hospira Inc	gemcitabine	0409-0187
>Company	>Ingredient	>NDC

gemcitabine drug variants not containing SODIUM ACETATE

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Company	Ingredient	NDC
Hikma Pharmaceuticals USA Inc	gemcitabine	0143-9340
Hospira Inc	gemcitabine	0409-0181
Accord Healthcare Inc	gemcitabine	16729-391
>Company	>Ingredient	>NDC

Excipient focus: SODIUM CHLORIDE

gemcitabine drug variants containing SODIUM CHLORIDE

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Company	Ingredient	NDC
Sun Pharmaceutical Industries Inc	gemcitabine	62756-073
>Company	>Ingredient	>NDC

gemcitabine drug variants not containing SODIUM CHLORIDE

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Company	Ingredient	NDC
Hikma Pharmaceuticals USA Inc	gemcitabine	0143-9340
Hikma Pharmaceuticals USA Inc	gemcitabine	0143-9394
Hospira Inc	gemcitabine	0409-0181
>Company	>Ingredient	>NDC

Excipient focus: SODIUM HYDROXIDE

gemcitabine drug variants containing SODIUM HYDROXIDE

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Company	Ingredient	NDC
Hikma Pharmaceuticals USA Inc	gemcitabine	0143-9340
Hikma Pharmaceuticals USA Inc	gemcitabine	0143-9394
Hospira Inc	gemcitabine	0409-0181
>Company	>Ingredient	>NDC

gemcitabine drug variants not containing SODIUM HYDROXIDE

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Company	Ingredient	NDC
Dr Reddy's Laboratories Limited	gemcitabine	55111-686
Bedford Laboratories	gemcitabine	55390-391
Accord Healthcare Inc	gemcitabine hydrochloride	16729-092
>Company	>Ingredient	>NDC

Excipient focus: UREA

gemcitabine drug variants containing UREA

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Company	Ingredient	NDC
Janssen Biotech Inc	gemcitabine intravesical	57894-225
>Company	>Ingredient	>NDC

gemcitabine drug variants not containing UREA

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Company	Ingredient	NDC
Hikma Pharmaceuticals USA Inc	gemcitabine	0143-9340
Hikma Pharmaceuticals USA Inc	gemcitabine	0143-9394
Hospira Inc	gemcitabine	0409-0181
>Company	>Ingredient	>NDC

Excipient focus: WATER

gemcitabine drug variants containing WATER

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Company	Ingredient	NDC
Hikma Pharmaceuticals USA Inc	gemcitabine	0143-9340
Hospira Inc	gemcitabine	0409-0181
Sagent Pharmaceuticals	gemcitabine	25021-239
>Company	>Ingredient	>NDC

gemcitabine drug variants not containing WATER

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Company	Ingredient	NDC
Hikma Pharmaceuticals USA Inc	gemcitabine	0143-9394
Hospira Inc	gemcitabine	0409-0185
Hospira Inc	gemcitabine	0409-0187
>Company	>Ingredient	>NDC

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