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
77038d38-946e-4918-a187-f743c0cf1799
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 21, 2017
Manufacturers
FDA
A-S Medication Solutions
DUNS: 830016429
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 Code50090-0281
Application NumberANDA040755
Product Classification
M
Marketing Category
C73584
G
Generic Name
Carisoprodol
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 13, 2017
FDA Product Classification
INGREDIENTS (8)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
CARISOPRODOLActive
Quantity: 350 mg in 1 1
Code: 21925K482H
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT