List of Excipients in API dexmedetomidine

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Excipients in NDA-approved (novel) drugs containing dexmedetomidine

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Company	Tradename	Ingredient	NDC	Excipient	Potential Generic Entry
BioXcel Therapeutics Inc	IGALMI	dexmedetomidine	81092-1120	FD&C BLUE NO. 1
BioXcel Therapeutics Inc	IGALMI	dexmedetomidine	81092-1120	HYDROXYPROPYL CELLULOSE
BioXcel Therapeutics Inc	IGALMI	dexmedetomidine	81092-1120	PEPPERMINT OIL
>Company	>Tradename	>Ingredient	>NDC	>Excipient	>Potential Generic Entry

Excipients in ANDA-approved (generic) drugs containing dexmedetomidine

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Company	Ingredient	NDC	Excipient
Accord Healthcare Inc	dexmedetomidine	16729-239	SODIUM CHLORIDE
Accord Healthcare Inc	dexmedetomidine	16729-239	WATER
Accord Healthcare Inc	dexmedetomidine	16729-432	SODIUM CHLORIDE
>Company	>Ingredient	>NDC	>Excipient

Detailed excipient profiles for dexmedetomidine

Excipient focus: ACETIC ACID

dexmedetomidine 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 drug variants not containing ACETIC ACID

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Company	Ingredient	NDC
Accord Healthcare Inc	dexmedetomidine	16729-239
Accord Healthcare Inc	dexmedetomidine	16729-432
Eugia US LLC	dexmedetomidine	55150-209
>Company	>Ingredient	>NDC

Excipient focus: FD&C BLUE NO. 1

dexmedetomidine drug variants containing FD&C BLUE NO. 1

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Company	Ingredient	NDC
BioXcel Therapeutics Inc	dexmedetomidine	81092-1120
>Company	>Ingredient	>NDC

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

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Company	Ingredient	NDC
Accord Healthcare Inc	dexmedetomidine	16729-239
Accord Healthcare Inc	dexmedetomidine	16729-432
Eugia US LLC	dexmedetomidine	55150-209
>Company	>Ingredient	>NDC

Excipient focus: HYDROXYPROPYL CELLULOSE

dexmedetomidine drug variants containing HYDROXYPROPYL CELLULOSE

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Company	Ingredient	NDC
BioXcel Therapeutics Inc	dexmedetomidine	81092-1120
>Company	>Ingredient	>NDC

dexmedetomidine drug variants not containing HYDROXYPROPYL CELLULOSE

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Company	Ingredient	NDC
Accord Healthcare Inc	dexmedetomidine	16729-239
Accord Healthcare Inc	dexmedetomidine	16729-432
Eugia US LLC	dexmedetomidine	55150-209
>Company	>Ingredient	>NDC

Excipient focus: METHIONINE

dexmedetomidine 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 drug variants not containing METHIONINE

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Company	Ingredient	NDC
Accord Healthcare Inc	dexmedetomidine	16729-239
Accord Healthcare Inc	dexmedetomidine	16729-432
Eugia US LLC	dexmedetomidine	55150-209
>Company	>Ingredient	>NDC

Excipient focus: METHYLPARABEN

dexmedetomidine drug variants containing METHYLPARABEN

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

dexmedetomidine drug variants not containing METHYLPARABEN

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Company	Ingredient	NDC
Accord Healthcare Inc	dexmedetomidine	16729-239
Accord Healthcare Inc	dexmedetomidine	16729-432
Eugia US LLC	dexmedetomidine	55150-209
>Company	>Ingredient	>NDC

Excipient focus: NITROGEN

dexmedetomidine drug variants containing NITROGEN

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

dexmedetomidine drug variants not containing NITROGEN

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Company	Ingredient	NDC
Accord Healthcare Inc	dexmedetomidine	16729-239
Accord Healthcare Inc	dexmedetomidine	16729-432
Eugia US LLC	dexmedetomidine	55150-209
>Company	>Ingredient	>NDC

Excipient focus: PEPPERMINT OIL

dexmedetomidine drug variants containing PEPPERMINT OIL

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Company	Ingredient	NDC
BioXcel Therapeutics Inc	dexmedetomidine	81092-1120
>Company	>Ingredient	>NDC

dexmedetomidine drug variants not containing PEPPERMINT OIL

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Company	Ingredient	NDC
Accord Healthcare Inc	dexmedetomidine	16729-239
Accord Healthcare Inc	dexmedetomidine	16729-432
Eugia US LLC	dexmedetomidine	55150-209
>Company	>Ingredient	>NDC

Excipient focus: POLYETHYLENE GLYCOL

dexmedetomidine drug variants containing POLYETHYLENE GLYCOL

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Company	Ingredient	NDC
BioXcel Therapeutics Inc	dexmedetomidine	81092-1120
>Company	>Ingredient	>NDC

dexmedetomidine drug variants not containing POLYETHYLENE GLYCOL

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Company	Ingredient	NDC
Accord Healthcare Inc	dexmedetomidine	16729-239
Accord Healthcare Inc	dexmedetomidine	16729-432
Eugia US LLC	dexmedetomidine	55150-209
>Company	>Ingredient	>NDC

Excipient focus: PROPYLPARABEN

dexmedetomidine drug variants containing PROPYLPARABEN

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

dexmedetomidine drug variants not containing PROPYLPARABEN

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Company	Ingredient	NDC
Accord Healthcare Inc	dexmedetomidine	16729-239
Accord Healthcare Inc	dexmedetomidine	16729-432
Eugia US LLC	dexmedetomidine	55150-209
>Company	>Ingredient	>NDC

Excipient focus: SODIUM ACETATE

dexmedetomidine 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 drug variants not containing SODIUM ACETATE

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Company	Ingredient	NDC
Accord Healthcare Inc	dexmedetomidine	16729-239
Accord Healthcare Inc	dexmedetomidine	16729-432
Eugia US LLC	dexmedetomidine	55150-209
>Company	>Ingredient	>NDC

Excipient focus: SODIUM CHLORIDE

dexmedetomidine drug variants containing SODIUM CHLORIDE

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Company	Ingredient	NDC
Accord Healthcare Inc	dexmedetomidine	16729-239
Accord Healthcare Inc	dexmedetomidine	16729-432
Eugia US LLC	dexmedetomidine	55150-209
>Company	>Ingredient	>NDC

dexmedetomidine drug variants not containing SODIUM CHLORIDE

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Company	Ingredient	NDC
BioXcel Therapeutics Inc	dexmedetomidine	81092-1120
>Company	>Ingredient	>NDC

Excipient focus: SUCRALOSE

dexmedetomidine drug variants containing SUCRALOSE

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Company	Ingredient	NDC
BioXcel Therapeutics Inc	dexmedetomidine	81092-1120
>Company	>Ingredient	>NDC

dexmedetomidine drug variants not containing SUCRALOSE

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Company	Ingredient	NDC
Accord Healthcare Inc	dexmedetomidine	16729-239
Accord Healthcare Inc	dexmedetomidine	16729-432
Eugia US LLC	dexmedetomidine	55150-209
>Company	>Ingredient	>NDC

Excipient focus: WATER

dexmedetomidine drug variants containing WATER

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Company	Ingredient	NDC
Accord Healthcare Inc	dexmedetomidine	16729-239
Accord Healthcare Inc	dexmedetomidine	16729-432
Eugia US LLC	dexmedetomidine	55150-209
>Company	>Ingredient	>NDC

dexmedetomidine drug variants not containing WATER

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Company	Ingredient	NDC
BioXcel Therapeutics Inc	dexmedetomidine	81092-1120
Hikma Pharmaceuticals USA Inc	dexmedetomidine hcl	0143-9532
Medical Purchasing Solutions LLC	dexmedetomidine hcl	71872-7218
>Company	>Ingredient	>NDC

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