Diazepam
Drug label sections C16H13ClN2O M.W. 284.74 Diazepam Tablets USP 2 mg, 5 mg and 10 mg, for oral administration, contain the following inactive ingredients: anhydrous lactose, magnesium stearate and microcrystalline cellulose. Diazepam Tablets USP 5 mg also contain D&C Yellow No. 10. Diazepam Tablets USP 10 mg also contain FD&C Blue No. 1.
Approved
Approval ID
0fab9e5b-395c-4b32-bbad-3e23b4059d2b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 2, 2010
Manufacturers
FDA
RedPharm Drug Inc.
DUNS: 008039641
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
diazepam
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code67296-0506
Application NumberANDA071135
Product Classification
M
Marketing Category
C73584
G
Generic Name
diazepam
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 12, 2010
FDA Product Classification
INGREDIENTS (4)
diazepamActive
Quantity: 5 mg in 1 1
Code: Q3JTX2Q7TU
Classification: ACTIB
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
anhydrous lactoseInactive
Code: 3SY5LH9PMK
Classification: IACT