Drug
Who makes lamotrigine?
43 companies list lamotrigine as a human prescription drug, including under the names LAMICTAL, LAMICTAL ODT, LAMICTAL XR, SUBVENITE. Forms: kit; suspension; tablet; tablet, chewable; tablet, extended release; tablet, film coated, extended release; tablet, for suspension; tablet, orally disintegrating. 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 lamotrigine
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| GlaxoSmithKline Biologicals SAUnited Kingdom | kit; tablet; tablet, film coated, extended release; tablet, for suspension | NDANDA020241, NDA020764, NDA022115 | 25 | 19 |
| Alembic Pharmaceuticals LimitedIndia | tablet; tablet, extended release; tablet, for suspension; tablet, orally disintegrating | ANDAANDA090607, ANDA201168, ANDA211821 | 24 | 7 |
| Zydus Pharmaceuticals USA Inc.India | tablet; tablet, chewable; tablet, extended release | ANDAANDA077633, ANDA078009, ANDA207763 | 14 | 1 |
| RemedyRepack, IncUnited States | tablet; tablet, extended release | ANDAANDA077633, ANDA078947, ANDA078956 | 13 | 1 |
| Dr. Reddy's Laboratories LimitedIndia | tablet; tablet, chewable; tablet, extended release | ANDAANDA076701, ANDA076708, ANDA202383 | 12 | 15 |
| Torrent Pharma, Inc.India | kit; tablet; tablet, extended release; tablet, orally disintegrating | ANDAANDA078947, ANDA203370, ANDA217100 | 12 | 5 |
| Par Health USA, LLCIndia | kit; tablet, film coated, extended release; tablet, orally disintegrating | ANDAANDA201374, ANDA204158 | 11 | 5 |
| OWP Pharmaceuticals, Inc. | kit; suspension; tablet | ANDA, NDAANDA078947, NDA218879 | 11 | 0 |
| Bryant Ranch PrepackUnited States | tablet; tablet, film coated, extended release | ANDAANDA077633, ANDA078525, ANDA079132 | 10 | 1 |
| AvKARE | tablet; tablet, film coated, extended release | ANDAANDA079132, ANDA207497 | 10 | 0 |
| Northstar Rx, LLC, | tablet; tablet, extended release | ANDAANDA077633, ANDA202383 | 10 | 0 |
| Amneal Pharmaceuticals of New York, LLCIndia | tablet, orally disintegrating | ANDAANDA200828 | 8 | 14 |
| Sun Pharmaceutical Industries LimitedIndia | tablet | ANDAANDA078525, ANDA219677 | 8 | 13 |
| Zydus Lifesciences LimitedIndia | tablet; tablet, chewable | ANDAANDA077633, ANDA078009 | 8 | 12 |
| International Medication Systems, Ltd.United States | tablet | ANDAANDA077633, ANDA078947, ANDA090170 | 6 | 3 |
| Amneal Ireland LimitedIreland | tablet, film coated, extended release | ANDAANDA207497 | 6 | 1 |
| Pharma Packaging Solutions, LLC dba Tjoapack, LLCUnited States | tablet | ANDAANDA077633 | 4 | 5 |
| Unichem Laboratories Limited, IndiaIndia | tablet | ANDAANDA090170 | 4 | 5 |
| ScieGen Pharmaceuticals India Private LimitedIndia | tablet, orally disintegrating | ANDAANDA206382 | 4 | 3 |
| Ajanta Pharma LimitedIndia | tablet, orally disintegrating | ANDAANDA213271 | 4 | 2 |
| Actavis LLCUnited States | tablet, film coated, extended release | ANDAANDA200672 | 4 | 1 |
| Coupler LLCUnited States | tablet | ANDAANDA078956, ANDA090170 | 4 | 1 |
| Golden State Medical Supply Inc.United States | tablet | ANDAANDA219677 | 4 | 1 |
| NCS HealthCare of KY, LLC dba Vangard LabsUnited States | tablet | ANDAANDA077633 | 4 | 1 |
| Nordic Pharma, Inc.United States | tablet | ANDAANDA214124 | 4 | 1 |
| Proficient Rx LPUnited States | tablet; tablet, extended release | ANDAANDA090170, ANDA203370 | 4 | 1 |
| ASCEND Therapeutics US, LLC | tablet | ANDAANDA200694 | 4 | 0 |
| Advagen Pharma Limited | tablet | ANDAANDA078625 | 4 | 0 |
| Dr. Reddys Laboratories Limited | tablet, orally disintegrating | ANDAANDA206382 | 4 | 0 |
| Jubilant Cadista Pharmacuticals Inc. | tablet | ANDAANDA079132 | 4 | 0 |
| Quallent Pharmaceuticals Health, LLC | tablet | ANDAANDA077633 | 4 | 0 |
| Cardinal Health 418, Inc.United States | tablet | ANDAANDA077633 | 3 | 34 |
| Aurobindo Pharma LimitedIndia | tablet; tablet, chewable | ANDAANDA078956, ANDA090401 | 3 | 6 |
| Northwind Health Company, LLCUnited States | tablet | ANDAANDA077633, ANDA078947, ANDA090170 | 3 | 1 |
| NuCare Pharmaceuticals,Inc.United States | tablet | ANDAANDA077633, ANDA078525, ANDA078947 | 3 | 1 |
| PD-Rx Pharmaceuticals Inc.United States | tablet | ANDAANDA078947, ANDA090170 | 3 | 1 |
| Preferred Pharmaceuticals Inc.United States | tablet | ANDAANDA077633, ANDA090170 | 3 | 1 |
| Glenmark Pharmaceuticals Inc., USAIndia | tablet, chewable | ANDAANDA079099 | 2 | 9 |
| Rising Pharma Holdings, Inc.United States | tablet, chewable | ANDAANDA090401 | 2 | 1 |
| MAJOR Pharmaceuticals Inc. | tablet | ANDAANDA077633 | 2 | 0 |
| ADVANCED RX PHARMACY OF TENNESSEE LLCUnited States | tablet | ANDAANDA090170 | 1 | 1 |
| ASCLEMED USA INC. DBA ENOVACHEMUnited States | tablet | ANDAANDA090170 | 1 | 1 |
| Direct RxUnited States | tablet | ANDAANDA090170 | 1 | 1 |
Bulk ingredient listings
- Cohance Lifesciences LimitedIndia · 2 NDC
- AX Pharmaceutical CorpCanada · 1 NDC
- Aurobindo Pharma LimitedIndia · 1 NDC
- CIPLA PHARMACEUTICALS LIMITEDIndia · 1 NDC
- CTX Lifesciences Pvt. Ltd.India · 1 NDC
- DIVI'S LABORATORIES LIMITEDIndia · 1 NDC
- Dr. Reddys Laboratories Limited · 1 NDC
- IOL Chemicals and Pharmaceuticals Ltd.India · 1 NDC
- Jubilant Biosys LimitedIndia · 1 NDC
- Matrix Pharmacorp Private LimitedIndia · 1 NDC
- Medichem SASpain · 1 NDC
- Optimus Drugs Private LimitedIndia · 1 NDC
- Professional Compounding Centers of America dba PCCAUnited States · 1 NDC
- SMS Pharmaceuticals LimitedIndia · 1 NDC
- Torrent Pharma, Inc.India · 1 NDC
- Unichem Laboratories Limited, IndiaIndia · 1 NDC
- Zhejiang Apeloa Jiayuan Pharmaceutical Co LtdChina · 1 NDC
- Zhejiang Supor Pharmaceuticals Co., Ltd · 1 NDC
- Zydus Lifesciences LimitedIndia · 1 NDC
Orange Book patents
5 unexpired patents list lamotrigine as the active ingredient, expiring between Jan 2029 and May 2040. Application holders: GLAXOSMITHKLINE LLC, OWP PHARMACEUTICALS INC.
Enquiry
Common questions
- Who makes lamotrigine?
- 43 companies list lamotrigine as a human prescription drug in the openFDA NDC Directory, led by GlaxoSmithKline Biologicals SA, Alembic Pharmaceuticals Limited, Zydus Pharmaceuticals USA Inc., RemedyRepack, Inc, Dr. Reddy's Laboratories Limited. 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 LAMICTAL?
- 42 companies list lamotrigine under an abbreviated new drug application (ANDA), the application type used for generics, and 2 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies lamotrigine active ingredient?
- 19 companies list lamotrigine as a bulk ingredient, including Cohance Lifesciences Limited, AX Pharmaceutical Corp, Aurobindo Pharma Limited, CIPLA PHARMACEUTICALS LIMITED.