22 companies list primidone as a human prescription drug in the openFDA NDC Directory, led by Advagen Pharma Limited, Aphena Pharma Solutions - Tennessee, LLC, Dr. Reddy's Laboratories Limited, Amneal Pharmaceuticals of New York, LLC, Pharma Packaging Solutions, LLC dba Tjoapack, LLC. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.

Is there a generic Mysoline?

21 companies list primidone under an abbreviated new drug application (ANDA), the application type used for generics, and 1 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.

Who supplies primidone active ingredient?

6 companies list primidone as a bulk ingredient, including Siegfried USA, LLC, AZICO BIOPHORE INDIA PRIVATE LIMITED, Dr. Reddy's Laboratories Limited, Nantong Jinghua Pharmaceutical Co., Ltd.

Drug

Who makes primidone?

22 companies list primidone as a human prescription drug, including under the names Mysoline. Forms: tablet. Routes: oral.

Labellers from the openFDA NDC Directory. A labeller is the firm named on the label, not necessarily the site that made the product, and a listing is not an FDA approval. Data as of 24 Sept 2026. Methodology

Companies listing primidone

Company	Forms	Application	NDCs	Registered sites
Advagen Pharma Limited	tablet	ANDAANDA214896	3	0
Aphena Pharma Solutions - Tennessee, LLC	tablet	ANDAANDA040586, ANDA084903	3	0
Dr. Reddy's Laboratories LimitedIndia	tablet	ANDAANDA040862	2	15
Amneal Pharmaceuticals of New York, LLCIndia	tablet	ANDAANDA040866	2	14
Pharma Packaging Solutions, LLC dba Tjoapack, LLCUnited States	tablet	ANDAANDA084903	2	5
Amneal Ireland LimitedIreland	tablet	ANDAANDA040866	2	1
Bausch Health US, LLCCanada	tablet	NDANDA009170	2	1
Bryant Ranch PrepackUnited States	tablet	ANDAANDA040586, ANDA040866	2	1
Carnegie Pharmaceuticals, LLCUnited States	tablet	ANDAANDA218366	2	1
Golden State Medical Supply Inc.United States	tablet	ANDAANDA084903	2	1
Lannett Company, LLCUnited States	tablet	ANDAANDA084903	2	1
NCS HealthCare of KY, LLC dba Vangard LabsUnited States	tablet	ANDAANDA040586, ANDA040866	2	1
Oxford Pharmaceuticals, LLCUnited States	tablet	ANDAANDA040586	2	1
PD-Rx Pharmaceuticals Inc.United States	tablet	ANDAANDA040586	2	1
Proficient Rx LPUnited States	tablet	ANDAANDA040586	2	1
AvKARE	tablet	ANDAANDA040866	2	0
AvPAK	tablet	ANDAANDA040866	2	0
Northstar Rx, LLC,	tablet	ANDAANDA214896	2	0
Actavis LLCUnited States	tablet	ANDAANDA083551	1	1
Direct RxUnited States	tablet	ANDAANDA040586	1	1
Chartwell RX, LLC.	tablet	ANDAANDA084903	1	0
TruPharma LLC.	tablet	ANDAANDA214896	1	0

Bulk ingredient listings

Siegfried USA, LLCUnited States · 2 NDC
AZICO BIOPHORE INDIA PRIVATE LIMITEDIndia · 1 NDC
Dr. Reddy's Laboratories LimitedIndia · 1 NDC
Nantong Jinghua Pharmaceutical Co., LtdChina · 1 NDC
Siegfried (Nantong) Pharmaceuticals Co, Ltd · 1 NDC
Spectrum Pharmaceuticals, Inc.United States · 1 NDC

Enquiry

Common questions

Who makes primidone?: 22 companies list primidone as a human prescription drug in the openFDA NDC Directory, led by Advagen Pharma Limited, Aphena Pharma Solutions - Tennessee, LLC, Dr. Reddy's Laboratories Limited, Amneal Pharmaceuticals of New York, LLC, Pharma Packaging Solutions, LLC dba Tjoapack, LLC. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
Is there a generic Mysoline?: 21 companies list primidone under an abbreviated new drug application (ANDA), the application type used for generics, and 1 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
Who supplies primidone active ingredient?: 6 companies list primidone as a bulk ingredient, including Siegfried USA, LLC, AZICO BIOPHORE INDIA PRIVATE LIMITED, Dr. Reddy's Laboratories Limited, Nantong Jinghua Pharmaceutical Co., Ltd.