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FDA Approval

CHLORZOXAZONE

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Effective Date
June 9, 2023
Labeling Type
Human Prescription Drug Label
Chlorzoxazone(500 mg in 1 1)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Graviti Pharmaceuticals Private Limited

Rising Pharma Holdings, Inc.

650884781

Products3

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

CHLORZOXAZONE

Product Details

NDC Product Code
16571-726
Application Number
ANDA213126
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
June 9, 2023
Code: H0DE420U8GClass: ACTIBQuantity: 500 mg in 1 1
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
DOCUSATE SODIUMInactive
Code: F05Q2T2JA0Class: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EUClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT

CHLORZOXAZONE

Product Details

NDC Product Code
16571-725
Application Number
ANDA213126
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
June 9, 2023
Code: H0DE420U8GClass: ACTIBQuantity: 375 mg in 1 1
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
DOCUSATE SODIUMInactive
Code: F05Q2T2JA0Class: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EUClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT

CHLORZOXAZONE

Product Details

NDC Product Code
16571-727
Application Number
ANDA213126
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
June 9, 2023
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
Code: H0DE420U8GClass: ACTIBQuantity: 750 mg in 1 1
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EUClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
DOCUSATE SODIUMInactive
Code: F05Q2T2JA0Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT

Drug Labeling Information

Complete FDA-approved labeling information including indications, dosage, warnings, contraindications, and other essential prescribing details.

DESCRIPTION SECTION

For Painful Musculoskeletal Conditions

PRESCRIBING INFORMATION

DESCRIPTION


Each 375 mg Chlorzoxazone tablet contains: Chlorzoxazone USP 375 mg.
Each 500 mg Chlorzoxazone tablet contains: Chlorzoxazone USP 500 mg.
Each 750 mg Chlorzoxazone tablet contains: Chlorzoxazone USP 750 mg.

Chemical Name: 5-Chloro-2-benzoxazolinone.

Structural Formula:

struct

Molecular Formula: C7H4CINO2

Molecular Weight: 169.56

Chlorzoxazone USP is a white or practically white, practically odorless, crystalline powder. Chlorzoxazone is slightly soluble in water; sparingly soluble in alcohol, in isopropyl alcohol, and in methanol; soluble in solutions of alkali hydroxides and ammonia.

Inactive ingredients: anhydrous lactose, croscarmellose sodium, docusate sodium with sodium benzoate, magnesium stearate, microcrystalline cellulose and pregelatinized maize starch.

FDA approved dissolution test specifications differ from USP.


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