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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 Initial U.S. Approval: 1959

Approved
Approval ID

7c6015ad-2158-400d-8c22-585ab277ea49

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Nov 8, 2018

Manufacturers
FDA

Vensun Pharmaceuticals, Inc.

DUNS: 078310501

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

CARISOPRODOL

PRODUCT DETAILS

NDC Product Code42543-700
Application NumberANDA203374
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateNovember 8, 2018
Generic NameCARISOPRODOL

INGREDIENTS (8)

CARISOPRODOLActive
Quantity: 350 mg in 1 1
Code: 21925K482H
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT

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CARISOPRODOL - FDA Drug Approval Details