MedPath

Chlorzoxazone

CHLORZOXAZONE TABLETS, USP

Approved
Approval ID

3b91e3ba-1eb6-4297-9d1b-28d87b36a5b3

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Sep 7, 2011

Manufacturers
FDA

Dispensing Solutions, Inc.

DUNS: 066070785

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 Code55045-1594
Application NumberANDA089895
Product Classification
M
Marketing Category
C73584
G
Generic Name
Chlorzoxazone
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 7, 2011
FDA Product Classification

INGREDIENTS (10)

CHLORZOXAZONEActive
Quantity: 500 mg in 1 1
Code: H0DE420U8G
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
DOCUSATE SODIUMInactive
Code: F05Q2T2JA0
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT

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Chlorzoxazone - FDA Drug Approval Details