FDA Product

Phenobarbital

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Product Name

Phenobarbital

FDA Product Code

0603-5165

Regulatory Information

NDC Product Code

0603-5165

Effective Date

August 14, 2021

FDA Title

Phenobarbital Tablets, USP CIVRx only

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

10

Company Information

ManufacturerPar Pharmaceutical, Inc.

DUNS Number

092733690

Active Ingredients

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

CELLULOSE, MICROCRYSTALLINE

Code: OP1R32D61U

Class Code: IACT

Quantity: 16.2 mg in 1 1

Code: YQE403BP4D

Class Code: ACTIB

LACTOSE MONOHYDRATE

Code: EWQ57Q8I5X

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATO

Code: 5856J3G2A2

Class Code: IACT

Active Moieties

PHENOBARBITAL

Code: YQE403BP4D

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