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
94778fd1-1cbc-4fbf-b167-25beb1d80769
Product Type
HUMAN PRESCRIPTION DRUG LABEL WITH HIGHLIGHTS
Effective Date
Apr 28, 2010
Manufacturers
FDA
Altura Pharmaceuticals, Inc.
DUNS: 006890545
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Carisoprodol Tablets
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63874-330
Application NumberANDA040124
Product Classification
M
Marketing Category
C73584
G
Generic Name
Carisoprodol Tablets
Product Specifications
Route of AdministrationORAL
Effective DateApril 28, 2010
FDA Product Classification
INGREDIENTS (8)
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CARISOPRODOLActive
Quantity: 350 mg in 1 1
Code: 21925K482H
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT