Diazepam
Approved
Approval ID
8b4946b3-ae6c-4174-bbd8-0b8ed2c8fdf3
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 Code58118-4047
Application NumberANDA070325
Product Classification
M
Marketing Category
C73584
G
Generic Name
diazepam
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 9, 2024
FDA Product Classification
INGREDIENTS (8)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
DIAZEPAMActive
Quantity: 10 mg in 1 1
Code: Q3JTX2Q7TU
Classification: ACTIB