Diazepam
Approved
Approval ID
b326c66d-5762-4d16-933c-619fa2088ccd
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 8, 2023
Manufacturers
FDA
Mylan Institutional Inc.
DUNS: 039615992
Products 3
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 Code51079-284
Application NumberANDA070325
Product Classification
M
Marketing Category
C73584
G
Generic Name
diazepam
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 8, 2023
FDA Product Classification
INGREDIENTS (6)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
DIAZEPAMActive
Quantity: 2 mg in 1 1
Code: Q3JTX2Q7TU
Classification: ACTIB
diazepam
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51079-285
Application NumberANDA070325
Product Classification
M
Marketing Category
C73584
G
Generic Name
diazepam
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 8, 2023
FDA Product Classification
INGREDIENTS (7)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
DIAZEPAMActive
Quantity: 5 mg in 1 1
Code: Q3JTX2Q7TU
Classification: ACTIB
diazepam
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51079-286
Application NumberANDA070325
Product Classification
M
Marketing Category
C73584
G
Generic Name
diazepam
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 8, 2023
FDA Product Classification
INGREDIENTS (8)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
DIAZEPAMActive
Quantity: 10 mg in 1 1
Code: Q3JTX2Q7TU
Classification: ACTIB