MedPath
FDA Approval

Chlorzoxazone

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

FDA Approval Summary

Company
Effective Date
September 23, 2010
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.

Rebel Distributors Corp

Rebel Distributors Corp

118802834

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
21695-569
Application Number
ANDA089895
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
November 3, 2006
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
Code: H0DE420U8GClass: ACTIBQuantity: 500 mg in 1 1
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
docusate sodiumInactive
Code: F05Q2T2JA0Class: IACT
sodium benzoateInactive
Code: OJ245FE5EUClass: IACT
magnesium stearateInactive
Code: 70097M6I30Class: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
© Copyright 2025. All Rights Reserved by MedPath