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Clorazepate Dipotassium

Clorazepate Dipotassium Tablets USP, 3.75 mg, 7.5 mg, & 15 mg

Approved
Approval ID

fb5c9e98-02b2-4c36-b436-25b58fe3c7d5

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Nov 1, 2022

Manufacturers
FDA

NORTHSTAR RX LLC

DUNS: 830546433

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 Code72603-113
Application NumberANDA075731
Product Classification
M
Marketing Category
C73584
G
Generic Name
Clorazepate Dipotassium
Product Specifications
Route of AdministrationORAL
Effective DateNovember 1, 2022
FDA Product Classification

INGREDIENTS (10)

Clorazepate DipotassiumActive
Quantity: 7.5 mg in 1 1
Code: 63FN7G03XY
Classification: ACTIB
magnesium oxideInactive
Code: 3A3U0GI71G
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
POTASSIUM CARBONATEInactive
Code: BQN1B9B9HA
Classification: IACT
potassium chlorideInactive
Code: 660YQ98I10
Classification: IACT
D&C Yellow No. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
talcInactive
Code: 7SEV7J4R1U
Classification: IACT
D&C RED NO. 6 BARIUM LAKEInactive
Code: K4XZD9W99K
Classification: IACT

Clorazepate Dipotassium

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code72603-112
Application NumberANDA075731
Product Classification
M
Marketing Category
C73584
G
Generic Name
Clorazepate Dipotassium
Product Specifications
Route of AdministrationORAL
Effective DateNovember 1, 2022
FDA Product Classification

INGREDIENTS (10)

magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
Clorazepate DipotassiumActive
Quantity: 3.75 mg in 1 1
Code: 63FN7G03XY
Classification: ACTIB
magnesium oxideInactive
Code: 3A3U0GI71G
Classification: IACT
potassium chlorideInactive
Code: 660YQ98I10
Classification: IACT
talcInactive
Code: 7SEV7J4R1U
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
POTASSIUM CARBONATEInactive
Code: BQN1B9B9HA
Classification: IACT
FD&C Red No. 40Inactive
Code: WZB9127XOA
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT

Clorazepate Dipotassium

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code72603-114
Application NumberANDA075731
Product Classification
M
Marketing Category
C73584
G
Generic Name
Clorazepate Dipotassium
Product Specifications
Route of AdministrationORAL
Effective DateNovember 1, 2022
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
magnesium oxideInactive
Code: 3A3U0GI71G
Classification: IACT
POTASSIUM CARBONATEInactive
Code: BQN1B9B9HA
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
talcInactive
Code: 7SEV7J4R1U
Classification: IACT
FD&C Red No. 40Inactive
Code: WZB9127XOA
Classification: IACT
potassium chlorideInactive
Code: 660YQ98I10
Classification: IACT
D&C RED NO. 6 BARIUM LAKEInactive
Code: K4XZD9W99K
Classification: IACT

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