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 Initial U.S. Approval: 1959
Approved
Approval ID
b38e1880-9152-4ca4-93e3-b9f6d14db958
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 7, 2011
Manufacturers
FDA
STAT RX USA LLC
DUNS: 786036330
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 Code16590-755
Application NumberNDA011792
Product Classification
M
Marketing Category
C73594
G
Generic Name
CARISOPRODOL
Product Specifications
Route of AdministrationORAL
Effective DateJuly 7, 2011
FDA Product Classification
INGREDIENTS (5)
alginic acidInactive
Code: 8C3Z4148WZ
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
CARISOPRODOLActive
Quantity: 250 mg in 1 1
Code: 21925K482H
Classification: ACTIB
potassium sorbateInactive
Code: 1VPU26JZZ4
Classification: IACT
tribasic calcium phosphateInactive
Code: 91D9GV0Z28
Classification: IACT