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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
March 8, 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.

A-S Medication Solutions

A-S Medication Solutions

830016429

Products1

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
50090-0315
Application Number
ANDA089859
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
August 27, 2019
Code: H0DE420U8GClass: ACTIBQuantity: 500 mg in 1 1
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
DOCUSATE SODIUMInactive
Code: F05Q2T2JA0Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EUClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT

Drug Labeling Information

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

DESCRIPTION SECTION

DESCRIPTION

Chlorzoxazone USP is a centrally acting skeletal muscle relaxant, available as tablets of 500 mg for oral administration. Its chemical name is 5-Chloro-2-benzoxazolinone, and its structural formula is:

Chlorzoxazone Structural Formula

Chlorzoxazone Structural Formula

C7H4CINO2 MW 169.57

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.

Chlorzoxazone tablets contain the inactive ingredients Docusate Sodium, Lactose (hydrous), Magnesium Stearate, Microcrystalline Cellulose, Pregelatinized Starch, Sodium Benzoate, and Sodium Starch Glycolate.


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