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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
September 7, 2011
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.

Dispensing Solutions, Inc.

Dispensing Solutions, Inc.

066070785

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
55045-1594
Application Number
ANDA089895
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
September 7, 2011
Code: H0DE420U8GClass: ACTIBQuantity: 500 mg in 1 1
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
DOCUSATE SODIUMInactive
Code: F05Q2T2JA0Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EUClass: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933Class: IACT
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