CLORAZEPATE DIPOTASSIUM
Clorazepate Dipotassium Tablets, USP CIV 3.75 mg, 7.5 mg and 15 mg Rx only
Approved
Approval ID
69451c35-dd9a-4690-8d5e-4dcfa8837620
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 20, 2024
Manufacturers
FDA
Aurolife Pharma LLC
DUNS: 829084461
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 Code13107-282
Application NumberANDA071858
Product Classification
M
Marketing Category
C73584
G
Generic Name
CLORAZEPATE DIPOTASSIUM
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 20, 2024
FDA Product Classification
INGREDIENTS (9)
CLORAZEPATE DIPOTASSIUMActive
Quantity: 3.75 mg in 1 1
Code: 63FN7G03XY
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM OXIDEInactive
Code: 3A3U0GI71G
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
POTASSIUM CARBONATEInactive
Code: BQN1B9B9HA
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
CLORAZEPATE DIPOTASSIUM
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code13107-284
Application NumberANDA071858
Product Classification
M
Marketing Category
C73584
G
Generic Name
CLORAZEPATE DIPOTASSIUM
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 20, 2024
FDA Product Classification
INGREDIENTS (8)
CLORAZEPATE DIPOTASSIUMActive
Quantity: 15 mg in 1 1
Code: 63FN7G03XY
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM OXIDEInactive
Code: 3A3U0GI71G
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POTASSIUM CARBONATEInactive
Code: BQN1B9B9HA
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
CLORAZEPATE DIPOTASSIUM
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code13107-283
Application NumberANDA071858
Product Classification
M
Marketing Category
C73584
G
Generic Name
CLORAZEPATE DIPOTASSIUM
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 20, 2024
FDA Product Classification
INGREDIENTS (9)
CLORAZEPATE DIPOTASSIUMActive
Quantity: 7.5 mg in 1 1
Code: 63FN7G03XY
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM OXIDEInactive
Code: 3A3U0GI71G
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POTASSIUM CARBONATEInactive
Code: BQN1B9B9HA
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT