Carisoprodol
These highlights do not include all the information needed to use CARISOPRODOL TABLETS safely and effectively. See full prescribing information for CARISOPRODOL TABLETS. CARISOPRODOL tablets, for oral use, C-IV Initial U.S. Approval: 1959
Approved
Approval ID
ab22f1be-16c8-45b6-adaf-09e08bf7a545
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 1, 2021
Manufacturers
FDA
Nostrum Laboratories, Inc.
DUNS: 791142354
Products 2
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 Code29033-214
Application NumberANDA207237
Product Classification
M
Marketing Category
C73584
G
Generic Name
Carisoprodol
Product Specifications
Route of AdministrationORAL
Effective DateNovember 1, 2021
FDA Product Classification
INGREDIENTS (7)
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
CARISOPRODOLActive
Quantity: 350 mg in 1 1
Code: 21925K482H
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
Carisoprodol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code29033-207
Application NumberANDA207237
Product Classification
M
Marketing Category
C73584
G
Generic Name
Carisoprodol
Product Specifications
Route of AdministrationORAL
Effective DateNovember 1, 2021
FDA Product Classification
INGREDIENTS (7)
CARISOPRODOLActive
Quantity: 250 mg in 1 1
Code: 21925K482H
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT