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, USP for Oral use CIV Initial U.S. Approval: 1959
Approved
Approval ID
78d4da6a-17d7-1d95-e053-2991aa0a8336
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 22, 2021
Manufacturers
FDA
NuCare Pharmaceuticals,Inc.
DUNS: 010632300
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 Code68071-4610
Application NumberANDA203374
Product Classification
M
Marketing Category
C73584
G
Generic Name
CARISOPRODOL
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 22, 2021
FDA Product Classification
INGREDIENTS (8)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
CARISOPRODOLActive
Quantity: 350 mg in 1 1
Code: 21925K482H
Classification: ACTIB