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Diazepam

Diazepam Tablets USP C-IV Rx only

Approved
Approval ID

d7d53a95-0398-4988-88aa-83e57de9c340

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Aug 1, 2011

Manufacturers
FDA

Contract Pharmacy Services-PA

DUNS: 945429777

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 Code67046-942
Application NumberANDA071136
Product Classification
M
Marketing Category
C73584
G
Generic Name
Diazepam
Product Specifications
Route of AdministrationORAL
Effective DateMay 11, 2006
FDA Product Classification

INGREDIENTS (5)

DiazepamActive
Quantity: 10 mg in 1 1
Code: Q3JTX2Q7TU
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
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 Code67046-941
Application NumberANDA071135
Product Classification
M
Marketing Category
C73584
G
Generic Name
Diazepam
Product Specifications
Route of AdministrationORAL
Effective DateMay 11, 2006
FDA Product Classification

INGREDIENTS (5)

DiazepamActive
Quantity: 5 mg in 1 1
Code: Q3JTX2Q7TU
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT

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Diazepam - FDA Drug Approval Details