FDA Product

Alprazolam

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

Basic Information

Product Name

Alprazolam

FDA Product Code

67544-414

Regulatory Information

NDC Product Code

67544-414

Application Number

NDA018276

Marketing Category

C73605

Effective Date

February 5, 2018

Territorial Authority

USA

FDA Title

Alprazolam Tablets, USP CIV

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

1

Company Information

ManufacturerAphena Pharma Solutions - Tennessee, LLC

DUNS Number

128385585

Active Ingredients

Quantity: 0.25 mg in 1 1

Code: YU55MQ3IZY

Class Code: ACTIB

Inactive Ingredients

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

POWDERED CELLULOSE

Code: SMD1X3XO9M

Class Code: IACT

DOCUSATE SODIUM

Code: F05Q2T2JA0

Class Code: IACT

LACTOSE, UNSPECIFIED FORM

Code: J2B2A4N98G

Class Code: IACT

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

SODIUM BENZOATE

Code: OJ245FE5EU

Class Code: IACT

Active Moieties

ALPRAZOLAM

Code: YU55MQ3IZY

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