Soma
These highlights do not include all the information needed to use SOMA safely and effectively. See full prescribing information for SOMA. SOMA (carisoprodol) tablets for oral use, CIVInitial U.S. Approval: 1959
Approved
Approval ID
6297cf20-830a-11dc-94c8-0002a5d5c51b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 15, 2023
Manufacturers
FDA
Meda Pharmaceuticals Inc.
DUNS: 051229602
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 Code0037-2250
Application NumberNDA011792
Product Classification
M
Marketing Category
C73594
G
Generic Name
Carisoprodol
Product Specifications
Route of AdministrationORAL
Effective DateMay 15, 2023
FDA Product Classification
INGREDIENTS (1)
CARISOPRODOLActive
Quantity: 250 mg in 1 1
Code: 21925K482H
Classification: ACTIB
Carisoprodol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0037-2001
Application NumberNDA011792
Product Classification
M
Marketing Category
C73594
G
Generic Name
Carisoprodol
Product Specifications
Route of AdministrationORAL
Effective DateMay 15, 2023
FDA Product Classification
INGREDIENTS (1)
CARISOPRODOLActive
Quantity: 350 mg in 1 1
Code: 21925K482H
Classification: ACTIB