Drug
Who makes oxcarbazepine?
43 companies list oxcarbazepine as a human prescription drug, including under the names OXTELLAR XR, Trileptal. Forms: for suspension; suspension; tablet; tablet, extended release; tablet, film coated. 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 oxcarbazepine
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| RemedyRepack, IncUnited States | tablet, film coated | ANDAANDA077802, ANDA078069, ANDA215939 | 13 | 1 |
| Bryant Ranch PrepackUnited States | suspension; tablet, film coated | ANDAANDA078069, ANDA202961, ANDA215939 | 8 | 1 |
| Advagen Pharma Limited | suspension; tablet; tablet, film coated | ANDAANDA077747, ANDA207717, ANDA215726 | 7 | 0 |
| Breckenridge Pharmaceutical, Inc. | tablet, film coated | ANDAANDA078069 | 6 | 0 |
| MAJOR Pharmaceuticals Inc. | tablet, film coated | ANDAANDA078069 | 6 | 0 |
| Coupler LLCUnited States | tablet, film coated | ANDAANDA077802, ANDA078005, ANDA078069 | 5 | 1 |
| Cardinal Health 418, Inc.United States | tablet, film coated | ANDAANDA078069, ANDA215939 | 4 | 34 |
| Novartis Pharmaceuticals CorporationSwitzerland | suspension; tablet, film coated | NDANDA021014, NDA021285 | 4 | 20 |
| Sun Pharmaceutical Industries LimitedIndia | suspension; tablet, film coated | ANDAANDA077794, ANDA078734 | 4 | 13 |
| Camber Pharmaceuticals, Inc.United States | suspension; tablet, film coated | ANDAANDA215939, ANDA216749 | 4 | 1 |
| Zydus Lifesciences LimitedIndia | tablet | ANDAANDA211747 | 3 | 12 |
| Glenmark Pharmaceuticals Inc., USAIndia | tablet, film coated | ANDAANDA077802 | 3 | 9 |
| Apotex Inc.Canada | tablet, extended release | ANDAANDA213369 | 3 | 6 |
| Pharma Packaging Solutions, LLC dba Tjoapack, LLCUnited States | tablet, film coated | ANDAANDA215939 | 3 | 5 |
| Ajanta Pharma LimitedIndia | tablet, extended release | ANDAANDA217659 | 3 | 2 |
| ANI Pharmaceuticals, Inc.United States | tablet, film coated | ANDAANDA078005 | 3 | 1 |
| Golden State Medical Supply Inc.United States | tablet, film coated | ANDAANDA078069 | 3 | 1 |
| NCS HealthCare of KY, LLC dba Vangard LabsUnited States | tablet, film coated | ANDAANDA078005 | 3 | 1 |
| Supernus Pharmaceuticals IncUnited States | tablet | NDANDA202810 | 3 | 1 |
| UMEDICA LABORATORIES PRIVATE LIMITEDIndia | tablet, film coated | ANDAANDA218341 | 3 | 1 |
| XLCare Pharmaceuticals Inc.United States | tablet, film coated | ANDAANDA215939 | 3 | 1 |
| Zydus Pharmaceuticals USA Inc.India | tablet | ANDAANDA211747 | 3 | 1 |
| AvPAK | tablet, film coated | ANDAANDA215939 | 3 | 0 |
| Ingenus Pharmaceuticals, LLC | tablet, extended release | ANDAANDA215796 | 3 | 0 |
| NorthStar RxLLC | suspension; tablet, film coated | ANDAANDA215939, ANDA216749 | 3 | 0 |
| Zameer Pharmaceuticals LLC | tablet, film coated | ANDAANDA218341 | 3 | 0 |
| Proficient Rx LPUnited States | tablet, film coated | ANDAANDA077802, ANDA215939 | 2 | 1 |
| Biocon Biologics LimitedIndia | suspension | ANDAANDA218278 | 1 | 9 |
| Macleods Pharmaceuticals LimitedIndia | for suspension | ANDAANDA207300 | 1 | 5 |
| Epic Laboratories, LLCUnited States | suspension | ANDAANDA215332 | 1 | 3 |
| ASCLEMED USA INC. DBA ENOVACHEMUnited States | tablet, film coated | ANDAANDA215939 | 1 | 1 |
| Amneal Ireland LimitedIreland | suspension | ANDAANDA202961 | 1 | 1 |
| Bionpharma Inc.India | suspension | ANDAANDA209652 | 1 | 1 |
| Direct RxUnited States | tablet, film coated | ANDAANDA077802 | 1 | 1 |
| Marlex Pharmaceuticals, IncUnited States | suspension | ANDAANDA217782 | 1 | 1 |
| Precision Dose Inc.United States | suspension | ANDAANDA202961 | 1 | 1 |
| Preferred Pharmaceuticals Inc.United States | tablet, film coated | ANDAANDA078069 | 1 | 1 |
| ASCEND Therapeutics US, LLC | suspension | ANDAANDA213183 | 1 | 0 |
| Chartwell Governmental & Specialty RX, LLC. | suspension | ANDAANDA212428 | 1 | 0 |
| Chartwell RX, LLC. | suspension | ANDAANDA212428 | 1 | 0 |
| DirectRx | tablet, film coated | ANDAANDA077794 | 1 | 0 |
| Kanchan Healthcare Inc | suspension | ANDAANDA217782 | 1 | 0 |
| Novadoz Pharmaceuticals LLC | suspension | ANDAANDA209020 | 1 | 0 |
Bulk ingredient listings
- Archimica S.p.A.Italy · 7 NDC
- FIS FABBRICA ITALIANA SINTETICI SPAItaly · 6 NDC
- Hubei Gedian Humanwell Pharmaceutical Co., LtdChina · 2 NDC
- ALMON HEALTHCARE PRIVATE LIMITEDIndia · 1 NDC
- Alivus Life Sciences Limited · 1 NDC
- Amoli Organics (A Division of Umedica Laboratories Pvt. Ltd.)India · 1 NDC
- Aurore Pharmaceuticals Private LimitedIndia · 1 NDC
- Bajaj Healthcare LtdIndia · 1 NDC
- CTX Lifesciences Pvt. Ltd.India · 1 NDC
- Dasami Lab Private LimitedIndia · 1 NDC
- Honour Lab LimitedIndia · 1 NDC
- Jubilant Biosys LimitedIndia · 1 NDC
- Lianhe Chemical Technology Co.,Ltd. · 1 NDC
- MSN Life Sciences Private LimitedIndia · 1 NDC
- NURAY CHEMICALS PRIVATE LIMITEDIndia · 1 NDC
- STHREE CHEMICALS PRIVATE LIMITEDIndia · 1 NDC
Orange Book patents
11 unexpired patents list oxcarbazepine as the active ingredient, expiring between Apr 2027 and Apr 2027. Application holder: SUPERNUS PHARMACEUTICALS INC.
Enquiry
Common questions
- Who makes oxcarbazepine?
- 43 companies list oxcarbazepine as a human prescription drug in the openFDA NDC Directory, led by RemedyRepack, Inc, Bryant Ranch Prepack, Advagen Pharma Limited, Breckenridge Pharmaceutical, Inc., MAJOR Pharmaceuticals Inc.. 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 OXTELLAR XR?
- 41 companies list oxcarbazepine 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 oxcarbazepine active ingredient?
- 16 companies list oxcarbazepine as a bulk ingredient, including Archimica S.p.A., FIS FABBRICA ITALIANA SINTETICI SPA, Hubei Gedian Humanwell Pharmaceutical Co., Ltd, ALMON HEALTHCARE PRIVATE LIMITED.