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Diazepam

DIAZEPAM TABLETS, USP

Approved
Approval ID

d6ff47b5-bf90-4ce5-8610-b86b5bfc00a9

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 27, 2013

Manufacturers
FDA

Aidarex Pharmaceuticals LLC

DUNS: 801503249

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 Code33261-035
Application NumberANDA077749
Product Classification
M
Marketing Category
C73584
G
Generic Name
diazepam
Product Specifications
Route of AdministrationORAL
Effective DateDecember 27, 2013
FDA Product Classification

INGREDIENTS (7)

DIAZEPAMActive
Quantity: 10 mg in 1 1
Code: Q3JTX2Q7TU
Classification: ACTIB
CALCIUM STEARATEInactive
Code: 776XM7047L
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT

diazepam

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code33261-034
Application NumberANDA077749
Product Classification
M
Marketing Category
C73584
G
Generic Name
diazepam
Product Specifications
Route of AdministrationORAL
Effective DateDecember 27, 2013
FDA Product Classification

INGREDIENTS (7)

DIAZEPAMActive
Quantity: 5 mg in 1 1
Code: Q3JTX2Q7TU
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CALCIUM STEARATEInactive
Code: 776XM7047L
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT

diazepam

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code33261-717
Application NumberANDA077749
Product Classification
M
Marketing Category
C73584
G
Generic Name
diazepam
Product Specifications
Route of AdministrationORAL
Effective DateDecember 27, 2013
FDA Product Classification

INGREDIENTS (6)

CALCIUM STEARATEInactive
Code: 776XM7047L
Classification: IACT
DIAZEPAMActive
Quantity: 2 mg in 1 1
Code: Q3JTX2Q7TU
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT

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Diazepam - FDA Drug Approval Details