MedPath

Chlorzoxazone

Revised:  March 2015 195609-1

Approved
Approval ID

6c418b8f-4a1c-4611-80d5-3a3a7dbca9c8

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Mar 8, 2023

Manufacturers
FDA

A-S Medication Solutions

DUNS: 830016429

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 Code50090-0315
Application NumberANDA089859
Product Classification
M
Marketing Category
C73584
G
Generic Name
Chlorzoxazone
Product Specifications
Route of AdministrationORAL
Effective DateAugust 27, 2019
FDA Product Classification

INGREDIENTS (8)

CHLORZOXAZONEActive
Quantity: 500 mg in 1 1
Code: H0DE420U8G
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
DOCUSATE SODIUMInactive
Code: F05Q2T2JA0
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT

Drug Labeling Information

DESCRIPTION SECTION

LOINC: 34089-3Updated: 3/6/2015

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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Chlorzoxazone - FDA Drug Approval Details