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Clorazepate Dipotassium

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

Approved
Approval ID

7fccd0b7-1abc-4c52-88e3-af7b7cc079a2

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Sep 25, 2023

Manufacturers
FDA

Bryant Ranch Prepack

DUNS: 171714327

Products 1

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 Code72162-2100
Application NumberANDA215566
Product Classification
M
Marketing Category
C73584
G
Generic Name
Clorazepate Dipotassium
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 25, 2023
FDA Product Classification

INGREDIENTS (10)

SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM OXIDEInactive
Code: 3A3U0GI71G
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CLORAZEPATE DIPOTASSIUMActive
Quantity: 15 mg in 1 1
Code: 63FN7G03XY
Classification: ACTIB
FD&C BLUE NO. 2--ALUMINUM LAKEInactive
Code: 4AQJ3LG584
Classification: IACT
POTASSIUM CARBONATEInactive
Code: BQN1B9B9HA
Classification: IACT
FD&C RED NO. 4 FREE ACIDInactive
Code: WJE3T5596E
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
POTASSIUM CHLORIDEInactive
Code: 660YQ98I10
Classification: IACT

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Clorazepate Dipotassium - FDA Drug Approval Details