MedPath

Parafon DSC

Parafon DSC (chlorzoxazone)

Approved
Approval ID

5af155d7-3780-435b-9a87-0ce01f1ed6ec

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Feb 9, 2010

Manufacturers
FDA

Keltman Pharmaceuticals Inc.

DUNS: 362861077

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 Code68387-375
Application NumberANDA089895
Product Classification
M
Marketing Category
C73584
G
Generic Name
Chlorzoxazone
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 9, 2010
FDA Product Classification

INGREDIENTS (10)

ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
ChlorzoxazoneActive
Quantity: 500 mg in 1 1
Code: H0DE420U8G
Classification: ACTIB
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
DOCUSATE SODIUMInactive
Code: F05Q2T2JA0
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT

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Parafon DSC - FDA Drug Approval Details