MedPath

Chlorzoxazone

Chlorzoxazone Tablets, USPRx Only

Approved
Approval ID

a65bdcb8-3d58-4549-80a8-f4189de3ba72

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Aug 23, 2023

Manufacturers
FDA

Graviti Pharmaceuticals Private Limited

DUNS: 650884781

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Chlorzoxazone

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code69844-054
Application NumberANDA216925
Product Classification
M
Marketing Category
C73584
G
Generic Name
Chlorzoxazone
Product Specifications
Route of AdministrationORAL
Effective DateAugust 23, 2023
FDA Product Classification

INGREDIENTS (7)

CHLORZOXAZONEActive
Quantity: 250 mg in 1 1
Code: H0DE420U8G
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
DOCUSATE SODIUM/SODIUM BENZOATEInactive
Code: 656HXR6YXN
Classification: IACT
MICROCRYSTALLINE CELLULOSE 101Inactive
Code: 7T9FYH5QMK
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT

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