MedPath

CHLORZOXAZONE

Chlorzoxazone Tablets, USP

Approved
Approval ID

1df6058b-7bf2-4246-9827-93fa023a5fd4

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jun 9, 2023

Manufacturers
FDA

Rising Pharma Holdings, Inc.

DUNS: 116880195

Products 3

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 Code16571-726
Application NumberANDA213126
Product Classification
M
Marketing Category
C73584
G
Generic Name
CHLORZOXAZONE
Product Specifications
Route of AdministrationORAL
Effective DateJune 9, 2023
FDA Product Classification

INGREDIENTS (8)

CHLORZOXAZONEActive
Quantity: 500 mg in 1 1
Code: H0DE420U8G
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
DOCUSATE SODIUMInactive
Code: F05Q2T2JA0
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT

CHLORZOXAZONE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code16571-725
Application NumberANDA213126
Product Classification
M
Marketing Category
C73584
G
Generic Name
CHLORZOXAZONE
Product Specifications
Route of AdministrationORAL
Effective DateJune 9, 2023
FDA Product Classification

INGREDIENTS (8)

CHLORZOXAZONEActive
Quantity: 375 mg in 1 1
Code: H0DE420U8G
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
DOCUSATE SODIUMInactive
Code: F05Q2T2JA0
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT

CHLORZOXAZONE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code16571-727
Application NumberANDA213126
Product Classification
M
Marketing Category
C73584
G
Generic Name
CHLORZOXAZONE
Product Specifications
Route of AdministrationORAL
Effective DateJune 9, 2023
FDA Product Classification

INGREDIENTS (8)

ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CHLORZOXAZONEActive
Quantity: 750 mg in 1 1
Code: H0DE420U8G
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
DOCUSATE SODIUMInactive
Code: F05Q2T2JA0
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT

Drug Labeling Information

DESCRIPTION SECTION

LOINC: 34089-3Updated: 6/9/2023

For Painful Musculoskeletal Conditions

PRESCRIBING INFORMATION

DESCRIPTION


Each 375 mg Chlorzoxazone tablet contains: Chlorzoxazone USP 375 mg.
Each 500 mg Chlorzoxazone tablet contains: Chlorzoxazone USP 500 mg.
Each 750 mg Chlorzoxazone tablet contains: Chlorzoxazone USP 750 mg.

Chemical Name: 5-Chloro-2-benzoxazolinone.

Structural Formula:

struct

Molecular Formula: C7H4CINO2

Molecular Weight: 169.56

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.

Inactive ingredients: anhydrous lactose, croscarmellose sodium, docusate sodium with sodium benzoate, magnesium stearate, microcrystalline cellulose and pregelatinized maize starch.

FDA approved dissolution test specifications differ from USP.

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

CHLORZOXAZONE - FDA Drug Approval Details