Clorazepate dipotassium
Approved
Approval ID
6e9edbfc-1950-4893-9d38-e82b119ddb9a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 12, 2012
Manufacturers
FDA
Ranbaxy Pharmaceuticals Inc.
DUNS: 937890044
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Clorazepate dipotassium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63304-552
Application NumberANDA076911
Product Classification
M
Marketing Category
C73584
G
Generic Name
Clorazepate dipotassium
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 12, 2012
FDA Product Classification
INGREDIENTS (8)
CLORAZEPATE DIPOTASSIUMActive
Quantity: 3.75 mg in 1 1
Code: 63FN7G03XY
Classification: ACTIB
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM OXIDEInactive
Code: 3A3U0GI71G
Classification: IACT
POTASSIUM CHLORIDEInactive
Code: 660YQ98I10
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POTASSIUM CARBONATEInactive
Code: BQN1B9B9HA
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
Clorazepate dipotassium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63304-554
Application NumberANDA076911
Product Classification
M
Marketing Category
C73584
G
Generic Name
Clorazepate dipotassium
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 12, 2012
FDA Product Classification
INGREDIENTS (8)
MAGNESIUM OXIDEInactive
Code: 3A3U0GI71G
Classification: IACT
CLORAZEPATE DIPOTASSIUMActive
Quantity: 15 mg in 1 1
Code: 63FN7G03XY
Classification: ACTIB
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
POTASSIUM CHLORIDEInactive
Code: 660YQ98I10
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POTASSIUM CARBONATEInactive
Code: BQN1B9B9HA
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
Clorazepate dipotassium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63304-553
Application NumberANDA076911
Product Classification
M
Marketing Category
C73584
G
Generic Name
Clorazepate dipotassium
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 12, 2012
FDA Product Classification
INGREDIENTS (8)
CLORAZEPATE DIPOTASSIUMActive
Quantity: 7.5 mg in 1 1
Code: 63FN7G03XY
Classification: ACTIB
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM OXIDEInactive
Code: 3A3U0GI71G
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POTASSIUM CARBONATEInactive
Code: BQN1B9B9HA
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POTASSIUM CHLORIDEInactive
Code: 660YQ98I10
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT