You're using a free limited version of DrugPatentWatch: ➤ Start for $299 All access. No Commitment.

Last Updated: December 12, 2025

Details for New Drug Application (NDA): 040862

✉ Email this page to a colleague

« Back to Dashboard

NDA 040862 describes PRIMIDONE, which is a drug marketed by Amneal Pharm, Chartwell Rx, Hikma Intl Pharms, Impax Labs, Lannett, Oxford Pharms, Pharmobedient, Rubicon Research, Tp Anda Holdings, and Watson Labs, and is included in eleven NDAs. It is available from twenty suppliers. Additional details are available on the PRIMIDONE profile page.

The generic ingredient in PRIMIDONE is primidone. There are seven drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the primidone profile page.

Summary for 040862

Tradename:	PRIMIDONE
Applicant:	Chartwell Rx
Ingredient:	primidone
Patents:	0

Pharmacology for NDA: 040862

Physiological Effect	Decreased Central Nervous System Disorganized Electrical Activity

Medical Subject Heading (MeSH) Categories for 040862

Anticonvulsants

Suppliers and Packaging for NDA: 040862

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PRIMIDONE	primidone	TABLET;ORAL	040862	ANDA	Dr. Reddy's Laboratories Limited	55111-476	55111-476-01	100 TABLET in 1 BOTTLE (55111-476-01)
PRIMIDONE	primidone	TABLET;ORAL	040862	ANDA	Dr. Reddy's Laboratories Limited	55111-476	55111-476-05	500 TABLET in 1 BOTTLE (55111-476-05)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	50MG
Approval Date:	Oct 3, 2008	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	250MG
Approval Date:	Oct 3, 2008	TE:		RLD:	No

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.