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Amytal Sodium

AMYTAL SODIUM CII (amobarbital sodium) FOR INJECTION, USP Vials CAUTION: These products are to be used under the direction of a physician. The intravenous administration of AMYTAL SODIUM (amobarbital sodium) FOR INJECTION, USP carries with it the potential dangers inherent in the intravenous use of any potent hypnotic.

Approved
Approval ID

a2523317-e071-4e04-9d9f-9053286e0ce2

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jul 1, 2020

Manufacturers
FDA

Bausch Health US, LLC

DUNS: 831922468

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

amobarbital sodium

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0187-4303
Product Classification
G
Generic Name
amobarbital sodium
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateJuly 1, 2020
FDA Product Classification

INGREDIENTS (1)

AMOBARBITAL SODIUMActive
Quantity: 0.5 g in 5 mL
Code: G0313KNC7D
Classification: ACTIB

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Amytal Sodium - FDA Drug Approval Details