Carisoprodol
These highlights do not include all the information needed to use Carisoprodol Tablets safely and effectively. See full prescribing information for Carisoprodol Tablets. Carisioprodol Tablets, USP for Oral Use. Initial U.S. Approval: 1959
Approved
Approval ID
f26dfb00-c55e-4cac-bc15-4f608e78a372
Product Type
HUMAN PRESCRIPTION DRUG LABEL WITH HIGHLIGHTS
Effective Date
Dec 1, 2009
Manufacturers
FDA
Rebel Distributors Corp.
DUNS: 118802834
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Carisoprodol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-021
Application NumberANDA040124
Product Classification
M
Marketing Category
C73584
G
Generic Name
Carisoprodol
Product Specifications
Route of AdministrationORAL
Effective DateDecember 1, 2009
FDA Product Classification
INGREDIENTS (5)
CARISOPRODOLActive
Quantity: 350 mg in 1 1
Code: 21925K482H
Classification: ACTIB
HYPROMELLOSEInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT