List of Excipients in API DEXMEDETOMIDINE HYDROCHLORIDE

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Excipients in NDA-approved (novel) drugs containing DEXMEDETOMIDINE HYDROCHLORIDE

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Company	Tradename	Ingredient	NDC	Excipient	Potential Generic Entry
Henry Schein Inc	PRECEDEX	dexmedetomidine hydrochloride	0404-9938	SODIUM CHLORIDE
Henry Schein Inc	PRECEDEX	dexmedetomidine hydrochloride	0404-9938	WATER
Hospira Inc	PRECEDEX	dexmedetomidine hydrochloride	0409-1454	SODIUM CHLORIDE
>Company	>Tradename	>Ingredient	>NDC	>Excipient	>Potential Generic Entry

Excipients in ANDA-approved (generic) drugs containing DEXMEDETOMIDINE HYDROCHLORIDE

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Company	Ingredient	NDC	Excipient
Hikma Pharmaceuticals USA Inc	dexmedetomidine hydrochloride	0143-9526	SODIUM CHLORIDE
Baxter Healthcare Company	dexmedetomidine hydrochloride	0338-9555	ACETIC ACID
Baxter Healthcare Company	dexmedetomidine hydrochloride	0338-9555	SODIUM ACETATE
>Company	>Ingredient	>NDC	>Excipient

Detailed excipient profiles for DEXMEDETOMIDINE HYDROCHLORIDE

Excipient focus: ACETIC ACID

DEXMEDETOMIDINE HYDROCHLORIDE drug variants containing ACETIC ACID

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Company	Ingredient	NDC
Baxter Healthcare Company	dexmedetomidine hydrochloride	0338-9555
Baxter Healthcare Corporation	dexmedetomidine hydrochloride	43066-561
Fresenius Kabi USA LLC	dexmedetomidine hydrochloride	63323-421
>Company	>Ingredient	>NDC

DEXMEDETOMIDINE HYDROCHLORIDE drug variants not containing ACETIC ACID

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Company	Ingredient	NDC
Hikma Pharmaceuticals USA Inc	dexmedetomidine hydrochloride	0143-9526
Henry Schein Inc	dexmedetomidine hydrochloride	0404-9938
Hospira Inc	dexmedetomidine hydrochloride	0409-1454
>Company	>Ingredient	>NDC

Excipient focus: METHIONINE

DEXMEDETOMIDINE HYDROCHLORIDE drug variants containing METHIONINE

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Company	Ingredient	NDC
Slayback Pharma LLC	dexmedetomidine hydrochloride	71225-126
Slayback Pharma LLC	dexmedetomidine hydrochloride	71225-132
CIVICA INC	dexmedetomidine hydrochloride	72572-127
>Company	>Ingredient	>NDC

DEXMEDETOMIDINE HYDROCHLORIDE drug variants not containing METHIONINE

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Company	Ingredient	NDC
Hikma Pharmaceuticals USA Inc	dexmedetomidine hydrochloride	0143-9526
Baxter Healthcare Company	dexmedetomidine hydrochloride	0338-9555
Henry Schein Inc	dexmedetomidine hydrochloride	0404-9938
>Company	>Ingredient	>NDC

Excipient focus: METHYLPARABEN

DEXMEDETOMIDINE HYDROCHLORIDE drug variants containing METHYLPARABEN

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Company	Ingredient	NDC
Somerset Therapeutics LLC	dexmedetomidine hydrochloride	70069-758
>Company	>Ingredient	>NDC

DEXMEDETOMIDINE HYDROCHLORIDE drug variants not containing METHYLPARABEN

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Company	Ingredient	NDC
Hikma Pharmaceuticals USA Inc	dexmedetomidine hydrochloride	0143-9526
Baxter Healthcare Company	dexmedetomidine hydrochloride	0338-9555
Henry Schein Inc	dexmedetomidine hydrochloride	0404-9938
>Company	>Ingredient	>NDC

Excipient focus: NITROGEN

DEXMEDETOMIDINE HYDROCHLORIDE drug variants containing NITROGEN

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Company	Ingredient	NDC
Somerset Therapeutics LLC	dexmedetomidine hydrochloride	70069-758
>Company	>Ingredient	>NDC

DEXMEDETOMIDINE HYDROCHLORIDE drug variants not containing NITROGEN

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Company	Ingredient	NDC
Hikma Pharmaceuticals USA Inc	dexmedetomidine hydrochloride	0143-9526
Baxter Healthcare Company	dexmedetomidine hydrochloride	0338-9555
Henry Schein Inc	dexmedetomidine hydrochloride	0404-9938
>Company	>Ingredient	>NDC

Excipient focus: PROPYLPARABEN

DEXMEDETOMIDINE HYDROCHLORIDE drug variants containing PROPYLPARABEN

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Company	Ingredient	NDC
Somerset Therapeutics LLC	dexmedetomidine hydrochloride	70069-758
>Company	>Ingredient	>NDC

DEXMEDETOMIDINE HYDROCHLORIDE drug variants not containing PROPYLPARABEN

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Company	Ingredient	NDC
Hikma Pharmaceuticals USA Inc	dexmedetomidine hydrochloride	0143-9526
Baxter Healthcare Company	dexmedetomidine hydrochloride	0338-9555
Henry Schein Inc	dexmedetomidine hydrochloride	0404-9938
>Company	>Ingredient	>NDC

Excipient focus: SODIUM ACETATE

DEXMEDETOMIDINE HYDROCHLORIDE drug variants containing SODIUM ACETATE

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Company	Ingredient	NDC
Baxter Healthcare Company	dexmedetomidine hydrochloride	0338-9555
Baxter Healthcare Corporation	dexmedetomidine hydrochloride	43066-561
Fresenius Kabi USA LLC	dexmedetomidine hydrochloride	63323-421
>Company	>Ingredient	>NDC

DEXMEDETOMIDINE HYDROCHLORIDE drug variants not containing SODIUM ACETATE

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Company	Ingredient	NDC
Hikma Pharmaceuticals USA Inc	dexmedetomidine hydrochloride	0143-9526
Henry Schein Inc	dexmedetomidine hydrochloride	0404-9938
Hospira Inc	dexmedetomidine hydrochloride	0409-1454
>Company	>Ingredient	>NDC

Excipient focus: SODIUM CHLORIDE

DEXMEDETOMIDINE HYDROCHLORIDE drug variants containing SODIUM CHLORIDE

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Company	Ingredient	NDC
Hikma Pharmaceuticals USA Inc	dexmedetomidine hydrochloride	0143-9526
Baxter Healthcare Company	dexmedetomidine hydrochloride	0338-9555
Henry Schein Inc	dexmedetomidine hydrochloride	0404-9938
>Company	>Ingredient	>NDC

DEXMEDETOMIDINE HYDROCHLORIDE drug variants not containing SODIUM CHLORIDE

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Company	Ingredient	NDC
>Company	>Ingredient	>NDC

Excipient focus: WATER

DEXMEDETOMIDINE HYDROCHLORIDE drug variants containing WATER

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Company	Ingredient	NDC
Baxter Healthcare Company	dexmedetomidine hydrochloride	0338-9555
Henry Schein Inc	dexmedetomidine hydrochloride	0404-9938
Hospira Inc	dexmedetomidine hydrochloride	0409-1454
>Company	>Ingredient	>NDC

DEXMEDETOMIDINE HYDROCHLORIDE drug variants not containing WATER

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Company	Ingredient	NDC
Hikma Pharmaceuticals USA Inc	dexmedetomidine hydrochloride	0143-9526
Fresenius Kabi USA LLC	dexmedetomidine hydrochloride	63323-421
Fresenius Kabi USA LLC	dexmedetomidine hydrochloride	63323-671
>Company	>Ingredient	>NDC

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