List of Excipients in API ZOLEDRONIC ACID

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Excipients in NDA-approved (novel) drugs containing ZOLEDRONIC ACID

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Company	Tradename	Ingredient	NDC	Excipient	Potential Generic Entry
Novartis Pharmaceuticals Corporation	RECLAST	zoledronic acid	0078-0435	MANNITOL
Novartis Pharmaceuticals Corporation	RECLAST	zoledronic acid	0078-0435	SODIUM CITRATE
Novartis Pharmaceuticals Corporation	RECLAST	zoledronic acid	0078-0435	WATER
Hospira Inc	ZOLEDRONIC ACID	zoledronic acid	0409-4229	MANNITOL
Hospira Inc	ZOLEDRONIC ACID	zoledronic acid	0409-4229	SODIUM CHLORIDE
Hospira Inc	ZOLEDRONIC ACID	zoledronic acid	0409-4229	SODIUM CITRATE
>Company	>Tradename	>Ingredient	>NDC	>Excipient	>Potential Generic Entry

Excipients in ANDA-approved (generic) drugs containing ZOLEDRONIC ACID

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Company	Ingredient	NDC	Excipient
Hikma Pharmaceuticals USA Inc	zoledronic acid	0143-9642	MANNITOL
Hikma Pharmaceuticals USA Inc	zoledronic acid	0143-9642	SODIUM CITRATE
Hikma Pharmaceuticals USA Inc	zoledronic acid	0143-9642	WATER
Hospira Inc	zoledronic acid	0409-4215	MANNITOL
Hospira Inc	zoledronic acid	0409-4215	SODIUM CITRATE
Hospira Inc	zoledronic acid	0409-4215	WATER
>Company	>Ingredient	>NDC	>Excipient

Detailed excipient profiles for ZOLEDRONIC ACID

Excipient focus: MANNITOL

ZOLEDRONIC ACID drug variants containing MANNITOL

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Company	Ingredient	NDC
Novartis Pharmaceuticals Corporation	zoledronic acid	0078-0435
Hikma Pharmaceuticals USA Inc	zoledronic acid	0143-9642
Hospira Inc	zoledronic acid	0409-4215
Hospira Inc	zoledronic acid	0409-4228
Hospira Inc	zoledronic acid	0409-4229
Northstar RxLLC	zoledronic acid	16714-815
>Company	>Ingredient	>NDC

ZOLEDRONIC ACID drug variants not containing MANNITOL

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Company	Ingredient	NDC
>Company	>Ingredient	>NDC

Excipient focus: SODIUM CHLORIDE

ZOLEDRONIC ACID drug variants containing SODIUM CHLORIDE

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Company	Ingredient	NDC
Hospira Inc	zoledronic acid	0409-4229
Sagent Pharmaceuticals	zoledronic acid	25021-826
>Company	>Ingredient	>NDC

ZOLEDRONIC ACID drug variants not containing SODIUM CHLORIDE

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Company	Ingredient	NDC
Novartis Pharmaceuticals Corporation	zoledronic acid	0078-0435
Hikma Pharmaceuticals USA Inc	zoledronic acid	0143-9642
Hospira Inc	zoledronic acid	0409-4215
Hospira Inc	zoledronic acid	0409-4228
Northstar RxLLC	zoledronic acid	16714-815
Accord Healthcare Inc	zoledronic acid	16729-242
>Company	>Ingredient	>NDC

Excipient focus: SODIUM CITRATE

ZOLEDRONIC ACID drug variants containing SODIUM CITRATE

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Company	Ingredient	NDC
Novartis Pharmaceuticals Corporation	zoledronic acid	0078-0435
Hikma Pharmaceuticals USA Inc	zoledronic acid	0143-9642
Hospira Inc	zoledronic acid	0409-4215
Hospira Inc	zoledronic acid	0409-4228
Hospira Inc	zoledronic acid	0409-4229
Northstar RxLLC	zoledronic acid	16714-815
>Company	>Ingredient	>NDC

ZOLEDRONIC ACID drug variants not containing SODIUM CITRATE

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Company	Ingredient	NDC
Eugia US LLC	zoledronic acid	55150-283
>Company	>Ingredient	>NDC

Excipient focus: TRISODIUM CITRATE DIHYDRATE

ZOLEDRONIC ACID drug variants containing TRISODIUM CITRATE DIHYDRATE

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Company	Ingredient	NDC
Eugia US LLC	zoledronic acid	55150-283
>Company	>Ingredient	>NDC

ZOLEDRONIC ACID drug variants not containing TRISODIUM CITRATE DIHYDRATE

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Company	Ingredient	NDC
Novartis Pharmaceuticals Corporation	zoledronic acid	0078-0435
Hikma Pharmaceuticals USA Inc	zoledronic acid	0143-9642
Hospira Inc	zoledronic acid	0409-4215
Hospira Inc	zoledronic acid	0409-4228
Hospira Inc	zoledronic acid	0409-4229
Northstar RxLLC	zoledronic acid	16714-815
>Company	>Ingredient	>NDC

Excipient focus: WATER

ZOLEDRONIC ACID drug variants containing WATER

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Company	Ingredient	NDC
Novartis Pharmaceuticals Corporation	zoledronic acid	0078-0435
Hikma Pharmaceuticals USA Inc	zoledronic acid	0143-9642
Hospira Inc	zoledronic acid	0409-4215
Hospira Inc	zoledronic acid	0409-4228
Hospira Inc	zoledronic acid	0409-4229
Northstar RxLLC	zoledronic acid	16714-815
>Company	>Ingredient	>NDC

ZOLEDRONIC ACID drug variants not containing WATER

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Company	Ingredient	NDC
Fresenius Kabi USA LLC	zoledronic acid	63323-966
Gland Pharma Limited	zoledronic acid	68083-135
>Company	>Ingredient	>NDC

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