Diazepam
Approved
Approval ID
09f4f9d9-0418-4688-bd49-2507bc12b234
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 7, 2019
Manufacturers
FDA
A-S Medication Solutions
DUNS: 830016429
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 Code50090-4566
Application NumberANDA070325
Product Classification
M
Marketing Category
C73584
G
Generic Name
diazepam
Product Specifications
Route of AdministrationORAL
Effective DateMay 15, 2017
FDA Product Classification
INGREDIENTS (7)
DIAZEPAMActive
Quantity: 5 mg in 1 1
Code: Q3JTX2Q7TU
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT