DIAZEPAM
DIAZEPAM 5MG AND 10MG USP CS-CIV Rx Only
Approved
Approval ID
792c3767-f660-4d13-89ed-c69e925f2232
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 15, 2010
Manufacturers
FDA
Apotheca, Inc.
DUNS: 051457844
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 Code12634-529
Application NumberANDA071321
Product Classification
M
Marketing Category
C73584
G
Generic Name
DIAZEPAM
Product Specifications
Route of AdministrationORAL
Effective DateMarch 12, 2010
FDA Product Classification
INGREDIENTS (9)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
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
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
DIAZEPAM
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code12634-698
Application NumberANDA070154
Product Classification
M
Marketing Category
C73584
G
Generic Name
DIAZEPAM
Product Specifications
Route of AdministrationORAL
Effective DateMarch 12, 2010
FDA Product Classification
INGREDIENTS (6)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
DIAZEPAMActive
Quantity: 10 mg in 1 1
Code: Q3JTX2Q7TU
Classification: ACTIB
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT