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ALPRAZOLAM

​ALPRAZOLAM

Approved
Approval ID

bc9dff5c-db3b-4cdf-b0bc-7ef94fd38486

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Sep 18, 2019

Manufacturers
FDA

Direct_Rx

DUNS: 079254320

Products 1

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

ALPRAZOLAM

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code61919-379
Application NumberANDA078491
Product Classification
M
Marketing Category
C73584
G
Generic Name
ALPRAZOLAM
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 18, 2019
FDA Product Classification

INGREDIENTS (8)

DOCUSATE SODIUMInactive
Code: F05Q2T2JA0
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
ALPRAZOLAMActive
Quantity: 0.25 mg in 1 1
Code: YU55MQ3IZY
Classification: ACTIB

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ALPRAZOLAM - FDA Drug Approval Details