Diazepam
Diazepam Tablets, USP, CIV Rx only
Approved
Approval ID
04cc10ad-7d5c-434e-9b29-85b14071492b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 29, 2023
Manufacturers
FDA
Bryant Ranch Prepack
DUNS: 171714327
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 Code63629-2948
Application NumberANDA071307
Product Classification
M
Marketing Category
C73584
G
Generic Name
Diazepam
Product Specifications
Route of AdministrationORAL
Effective DateOctober 2, 2023
FDA Product Classification
INGREDIENTS (7)
DIAZEPAMActive
Quantity: 2 mg in 1 1
Code: Q3JTX2Q7TU
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT