FDA Product

Diazepam

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

Basic Information

Product Name

Diazepam

FDA Product Code

66336-478

Regulatory Information

NDC Product Code

66336-478

Application Number

ANDA077749

Marketing Category

C73584

Effective Date

September 10, 2013

Territorial Authority

USA

FDA Title

DIAZEPAM TABLETS, USP

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

3

Company Information

ManufacturerDispensing Solutions, Inc.

DUNS Number

066070785

Active Ingredients

Quantity: 5 mg in 1 1

Code: Q3JTX2Q7TU

Class Code: ACTIB

CALCIUM STEARATE

Code: 776XM7047L

Class Code: IACT

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

D&C YELLOW NO. 10

Code: 35SW5USQ3G

Class Code: IACT

LACTOSE MONOHYDRATE

Code: EWQ57Q8I5X

Class Code: IACT

CELLULOSE, MICROCRYSTALLINE

Code: OP1R32D61U

Class Code: IACT

CROSCARMELLOSE SODIUM

Code: M28OL1HH48

Class Code: IACT

Active Moieties

DIAZEPAM

Code: Q3JTX2Q7TU

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