Clorazepate Dipotassium
Clorazepate Dipotassium Tablets USP, 3.75 mg, 7.5 mg, & 15 mg
Approved
Approval ID
499a6989-8912-44b7-b1eb-ee8f85ae378f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 9, 2023
Manufacturers
FDA
Taro Pharmaceuticals U.S.A., Inc.
DUNS: 145186370
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 Code51672-4043
Application NumberANDA075731
Product Classification
M
Marketing Category
C73584
G
Generic Name
Clorazepate Dipotassium
Product Specifications
Route of AdministrationORAL
Effective DateNovember 9, 2023
FDA Product Classification
INGREDIENTS (10)
Clorazepate DipotassiumActive
Quantity: 7.5 mg in 1 1
Code: 63FN7G03XY
Classification: ACTIB
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
magnesium oxideInactive
Code: 3A3U0GI71G
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
POTASSIUM CARBONATEInactive
Code: BQN1B9B9HA
Classification: IACT
potassium chlorideInactive
Code: 660YQ98I10
Classification: IACT
talcInactive
Code: 7SEV7J4R1U
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
D&C RED NO. 6 BARIUM LAKEInactive
Code: K4XZD9W99K
Classification: IACT
D&C Yellow No. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
Clorazepate Dipotassium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51672-4042
Application NumberANDA075731
Product Classification
M
Marketing Category
C73584
G
Generic Name
Clorazepate Dipotassium
Product Specifications
Route of AdministrationORAL
Effective DateNovember 9, 2023
FDA Product Classification
INGREDIENTS (10)
Clorazepate DipotassiumActive
Quantity: 3.75 mg in 1 1
Code: 63FN7G03XY
Classification: ACTIB
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
magnesium oxideInactive
Code: 3A3U0GI71G
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POTASSIUM CARBONATEInactive
Code: BQN1B9B9HA
Classification: IACT
potassium chlorideInactive
Code: 660YQ98I10
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
FD&C Red No. 40Inactive
Code: WZB9127XOA
Classification: IACT
talcInactive
Code: 7SEV7J4R1U
Classification: IACT
Clorazepate Dipotassium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51672-4044
Application NumberANDA075731
Product Classification
M
Marketing Category
C73584
G
Generic Name
Clorazepate Dipotassium
Product Specifications
Route of AdministrationORAL
Effective DateNovember 9, 2023
FDA Product Classification
INGREDIENTS (10)
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
Clorazepate DipotassiumActive
Quantity: 15 mg in 1 1
Code: 63FN7G03XY
Classification: ACTIB
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
potassium chlorideInactive
Code: 660YQ98I10
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POTASSIUM CARBONATEInactive
Code: BQN1B9B9HA
Classification: IACT
magnesium oxideInactive
Code: 3A3U0GI71G
Classification: IACT
talcInactive
Code: 7SEV7J4R1U
Classification: IACT
D&C RED NO. 6 BARIUM LAKEInactive
Code: K4XZD9W99K
Classification: IACT
FD&C Red No. 40Inactive
Code: WZB9127XOA
Classification: IACT