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Last Updated: December 28, 2025

Details for New Drug Application (NDA): 040245

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NDA 040245 describes CARISOPRODOL, which is a drug marketed by Able, Accelrx Labs, Aurobindo Pharma, Chartwell Rx, Epic Pharma Llc, Fosun Wanbang, Heritage, Hikma Intl Pharms, Mpp Pharma, Natco, Novast Labs, Orient Pharma Co Ltd, Oxford Pharms, Pioneer Pharms, Pointview Hldings, Sandoz, Sciegen Pharms Inc, Strides Pharma, Sun Pharm Inds Ltd, Sun Pharm Industries, Watson Labs, Watson Labs Teva, Chartwell, and Ingenus Pharms Nj, and is included in thirty-two NDAs. It is available from twenty-five suppliers. Additional details are available on the CARISOPRODOL profile page.

The generic ingredient in CARISOPRODOL is aspirin; carisoprodol; codeine phosphate. There are twenty-two drug master file entries for this compound. Additional details are available on the aspirin; carisoprodol; codeine phosphate profile page.

Summary for 040245

Tradename:	CARISOPRODOL
Applicant:	Chartwell Rx
Ingredient:	carisoprodol
Patents:	0

Pharmacology for NDA: 040245

Physiological Effect	Centrally-mediated Muscle Relaxation

Medical Subject Heading (MeSH) Categories for 040245

Muscle Relaxants, Central

Suppliers and Packaging for NDA: 040245

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CARISOPRODOL	carisoprodol	TABLET;ORAL	040245	ANDA	Chartwell RX, LLC	62135-241	62135-241-12	120 TABLET in 1 BOTTLE (62135-241-12)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	350MG
Approval Date:	Sep 8, 1997	TE:	AA	RLD:	No

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