Drug
Who makes naltrexone hydrochloride?
21 companies list naltrexone hydrochloride as a human prescription drug. Forms: 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 naltrexone hydrochloride
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Bryant Ranch PrepackUnited States | tablet, film coated | ANDAANDA075274, ANDA076264, ANDA090356 | 18 | 1 |
| Aphena Pharma Solutions - Tennessee, LLC | tablet, film coated | ANDAANDA075274, ANDA076264 | 4 | 0 |
| International Medication Systems, Ltd.United States | tablet, film coated | ANDAANDA076264, ANDA091205 | 2 | 3 |
| Coupler LLCUnited States | tablet, film coated | ANDAANDA075274, ANDA090356 | 2 | 1 |
| Precision Dose Inc.United States | tablet, film coated | ANDAANDA075274 | 2 | 1 |
| RemedyRepack, IncUnited States | tablet, film coated | ANDAANDA075274, ANDA090356 | 2 | 1 |
| Sun Pharmaceutical Industries LimitedIndia | tablet, film coated | ANDAANDA090356 | 1 | 13 |
| Pharma Packaging Solutions, LLC dba Tjoapack, LLCUnited States | tablet, film coated | ANDAANDA076264 | 1 | 5 |
| SpecGx LLCUnited States | tablet, film coated | ANDAANDA076264 | 1 | 5 |
| ACCORD HEALTHCARE LIMITEDUnited Kingdom | tablet, film coated | ANDAANDA091205 | 1 | 2 |
| Elite Laboratories, Inc.United States | tablet, film coated | ANDAANDA075274 | 1 | 1 |
| Golden State Medical Supply Inc.United States | tablet, film coated | ANDAANDA076264 | 1 | 1 |
| Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.United States | tablet, film coated | ANDAANDA207905 | 1 | 1 |
| NCS HealthCare of KY, LLC dba Vangard LabsUnited States | tablet, film coated | ANDAANDA090356 | 1 | 1 |
| NuCare Pharmaceuticals,Inc.United States | tablet, film coated | ANDAANDA075274 | 1 | 1 |
| Proficient Rx LPUnited States | tablet, film coated | ANDAANDA090356 | 1 | 1 |
| RedPharm DrugUnited States | tablet, film coated | ANDAANDA091205 | 1 | 1 |
| AvKARE | tablet, film coated | ANDAANDA075274 | 1 | 0 |
| Chartwell RX, LLC. | tablet, film coated | ANDAANDA207905 | 1 | 0 |
| MAJOR Pharmaceuticals Inc. | tablet, film coated | ANDAANDA090356 | 1 | 0 |
| TAGI Pharma, Inc. | tablet, film coated | ANDAANDA075274 | 1 | 0 |
Bulk ingredient listings
- Willow Birch Pharma, LLCUnited States · 5 NDC
- Siegfried USA, LLCUnited States · 3 NDC
- MEDISCA Inc.United States · 2 NDC
- Sun Pharmaceutical Industries LimitedIndia · 2 NDC
- ALMON HEALTHCARE PRIVATE LIMITEDIndia · 1 NDC
- Arevipharma GmbHGermany · 1 NDC
- Aspen Oss B.V.Netherlands · 1 NDC
- FRANCOPIA · 1 NDC
- Galenova IncCanada · 1 NDC
- NURAY CHEMICALS PRIVATE LIMITEDIndia · 1 NDC
- Noramco, LLCUnited States · 1 NDC
- Rusan Pharma Ltd.India · 1 NDC
- S.A.L.A.R.S. SOCIET AZIONARIA LABORATORI ALCALOIDI RIFORNIMENTI SANITARI S.P.A. · 1 NDC
- STHREE CHEMICALS PRIVATE LIMITEDIndia · 1 NDC
- Saneca Pharmaceuticals a.s.Slovakia · 1 NDC
- Sanofi Winthrop Industrie · 1 NDC
- Siegfried PharmaChemikalien Minden Gmbh · 1 NDC
- SpecGx LLCUnited States · 1 NDC
- WAVELENGTH ENTERPRISES LTDIsrael · 1 NDC
- XENEX LABORATORIES INCCanada · 1 NDC
Enquiry
Common questions
- Who makes naltrexone hydrochloride?
- 21 companies list naltrexone hydrochloride as a human prescription drug in the openFDA NDC Directory, led by Bryant Ranch Prepack, Aphena Pharma Solutions - Tennessee, LLC, International Medication Systems, Ltd., Coupler LLC, Precision Dose 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 naltrexone hydrochloride?
- 21 companies list naltrexone hydrochloride under an abbreviated new drug application (ANDA), the application type used for generics. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies naltrexone hydrochloride active ingredient?
- 20 companies list naltrexone hydrochloride as a bulk ingredient, including Willow Birch Pharma, LLC, Siegfried USA, LLC, MEDISCA Inc., Sun Pharmaceutical Industries Limited.