Diazepam
Diazepam Tablets USP CIVRx only
Approved
Approval ID
83c1f93b-0fc6-4512-9c8f-9167b217d7f9
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 9, 2024
Manufacturers
FDA
Clinical Solutions Wholesale, LLC
DUNS: 078710347
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 Code58118-3925
Application NumberANDA071307
Product Classification
M
Marketing Category
C73584
G
Generic Name
Diazepam
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 9, 2024
FDA Product Classification
INGREDIENTS (7)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
DIAZEPAMActive
Quantity: 2 mg in 1 1
Code: Q3JTX2Q7TU
Classification: ACTIB