CHLORZOXAZONE
Revised: November 2010 195609
Approved
Approval ID
ddd41f29-8c98-4fae-94e3-104a8e9365fc
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 23, 2011
Manufacturers
FDA
STAT Rx USA LLC
DUNS: 786036330
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 Code16590-478
Application NumberANDA089859
Product Classification
M
Marketing Category
C73584
G
Generic Name
CHLORZOXAZONE
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 23, 2011
FDA Product Classification
INGREDIENTS (8)
CHLORZOXAZONEActive
Quantity: 500 mg in 1 1
Code: H0DE420U8G
Classification: ACTIB
DOCUSATE SODIUMInactive
Code: F05Q2T2JA0
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
STARCH, PREGELATINIZED CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT