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Chlorzoxazone

CHLORZOXAZONE TABLETS, USP 500 mg0542

Approved
Approval ID

e1e1c8de-5658-4f94-bf20-f42b59b993c5

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Sep 23, 2010

Manufacturers
FDA

Rebel Distributors Corp

DUNS: 118802834

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 Code21695-569
Application NumberANDA089895
Product Classification
M
Marketing Category
C73584
G
Generic Name
Chlorzoxazone
Product Specifications
Route of AdministrationORAL
Effective DateNovember 3, 2006
FDA Product Classification

INGREDIENTS (8)

LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
ChlorzoxazoneActive
Quantity: 500 mg in 1 1
Code: H0DE420U8G
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
docusate sodiumInactive
Code: F05Q2T2JA0
Classification: IACT
sodium benzoateInactive
Code: OJ245FE5EU
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT

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Chlorzoxazone - FDA Drug Approval Details