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
0d7b9219-8529-4395-a6f4-d7612a7f5278
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 12, 2019
Manufacturers
FDA
Orient Pharma Co., Ltd.
DUNS: 658849810
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 Code76333-135
Application NumberANDA205085
Product Classification
M
Marketing Category
C73584
G
Generic Name
Carisoprodol
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 13, 2019
FDA Product Classification
INGREDIENTS (7)
CarisoprodolActive
Quantity: 350 mg in 1 1
Code: 21925K482H
Classification: ACTIB
Lactose MonohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
Cellulose, MicrocrystallineInactive
Code: OP1R32D61U
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
Croscarmellose SodiumInactive
Code: M28OL1HH48
Classification: IACT
Povidone K30Inactive
Code: U725QWY32X
Classification: IACT
TalcInactive
Code: 7SEV7J4R1U
Classification: IACT