Clorazepate Dipotassium
Clorazepate Dipotassium Tablets USP, 15 mg
Approved
Approval ID
6442448e-aa40-40c9-a117-2e689aa5321c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 27, 2023
Manufacturers
FDA
PD-Rx Pharmaceuticals, Inc.
DUNS: 156893695
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 Code43063-893
Application NumberANDA075731
Product Classification
M
Marketing Category
C73584
G
Generic Name
Clorazepate Dipotassium
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 27, 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
POTASSIUM CARBONATEInactive
Code: BQN1B9B9HA
Classification: IACT
POTASSIUM CHLORIDEInactive
Code: 660YQ98I10
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
CLORAZEPATE DIPOTASSIUMActive
Quantity: 15 mg in 1 1
Code: 63FN7G03XY
Classification: ACTIB