Diazepam
Diazepam
Approved
Approval ID
66ea2936-8b6c-4b72-b077-ecf88e83fee7
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 21, 2012
Manufacturers
FDA
STAT Rx USA LLC
DUNS: 786036330
Products 2
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 Code42549-603
Application NumberANDA070325
Product Classification
M
Marketing Category
C73584
G
Generic Name
Diazepam
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 21, 2012
FDA Product Classification
INGREDIENTS (7)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
DIAZEPAMActive
Quantity: 5 mg in 1 1
Code: Q3JTX2Q7TU
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
Diazepam
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42549-554
Application NumberANDA070325
Product Classification
M
Marketing Category
C73584
G
Generic Name
Diazepam
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 21, 2012
FDA Product Classification
INGREDIENTS (8)
DIAZEPAMActive
Quantity: 10 mg in 1 1
Code: Q3JTX2Q7TU
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT