Carisoprodol
These highlights do not include all the information needed to use Carisoprodol Tablets, USP safely and effectively. See full prescribing information for Carisoprodol Tablets, USP. Carisoprodol Tablets for Oral use Initial U.S. Approval: 1959
Approved
Approval ID
9e517e32-d5ac-438d-b613-306e6aa6c45b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 7, 2011
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.
Carisoprodol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68387-600
Application NumberANDA040124
Product Classification
M
Marketing Category
C73584
G
Generic Name
Carisoprodol
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 7, 2011
FDA Product Classification
INGREDIENTS (10)
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CARISOPRODOLActive
Quantity: 350 mg in 1 1
Code: 21925K482H
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
METHYLCELLULOSE (100 CPS)Inactive
Code: 4GFU244C4J
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT