Drug
Who makes duloxetine hydrochloride?
16 companies list duloxetine hydrochloride as a human prescription drug, including under the names Cymbalta. Forms: capsule, delayed release; capsule, delayed release pellets. 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 duloxetine hydrochloride
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Bryant Ranch PrepackUnited States | capsule, delayed release pellets | ANDAANDA203088 | 12 | 1 |
| Proficient Rx LPUnited States | capsule, delayed release; capsule, delayed release pellets | ANDAANDA090778, ANDA203088 | 6 | 1 |
| Aphena Pharma Solutions - Tennessee, LLC | capsule, delayed release; capsule, delayed release pellets | ANDAANDA090778, ANDA203088 | 6 | 0 |
| Golden State Medical Supply Inc.United States | capsule, delayed release pellets | ANDAANDA203088 | 4 | 1 |
| Breckenridge Pharmaceutical, Inc. | capsule, delayed release pellets | ANDAANDA203088 | 4 | 0 |
| Quallent Pharmaceuticals Health, LLC | capsule, delayed release pellets | ANDAANDA203088 | 4 | 0 |
| Eli Lilly and CompanyUnited States | capsule, delayed release | NDANDA021427 | 3 | 10 |
| Macleods Pharmaceuticals LimitedIndia | capsule, delayed release | ANDAANDA204815 | 3 | 5 |
| MARKSANS PHARMA LIMITEDIndia | capsule, delayed release | ANDAANDA090723 | 3 | 2 |
| Yaopharma Co., Ltd.China | capsule, delayed release pellets | ANDAANDA207219 | 3 | 1 |
| International Medication Systems, Ltd.United States | capsule, delayed release pellets | ANDAANDA203088 | 2 | 3 |
| Preferred Pharmaceuticals Inc.United States | capsule, delayed release pellets | ANDAANDA203088 | 2 | 1 |
| Aurobindo Pharma LimitedIndia | capsule, delayed release | ANDAANDA090778 | 1 | 6 |
| NuCare Pharmaceuticals,Inc.United States | capsule, delayed release pellets | ANDAANDA203088 | 1 | 1 |
| RemedyRepack, IncUnited States | capsule, delayed release pellets | ANDAANDA203088 | 1 | 1 |
| BluePoint Laboratories Inc. | capsule, delayed release pellets | ANDAANDA203088 | 1 | 0 |
Bulk ingredient listings
- Aurobindo Pharma LimitedIndia · 1 NDC
- Dr. Reddy's Laboratories LimitedIndia · 1 NDC
- Evonik Operations GmbHGermany · 1 NDC
- MSN Laboratories Private Limited,India · 1 NDC
- Professional Compounding Centers of America dba PCCAUnited States · 1 NDC
- R.L.Fine Chem Private LimitedIndia · 1 NDC
- SCI PHARMTECH, INC.Taiwan · 1 NDC
- Shanghai Wonder Pharmaceutical Co., LtdChina · 1 NDC
- Signa S.A. de C.V.Mexico · 1 NDC
- Sun Pharmaceutical Industries LimitedIndia · 1 NDC
- YiChang HEC ChangJiang Pharmaceutical Co., Ltd.China · 1 NDC
- Zydus Lifesciences LimitedIndia · 1 NDC
Orange Book patents
6 unexpired patents list duloxetine hydrochloride as the active ingredient, expiring between Apr 2037 and Jan 2046. Application holders: ALMATICA PHARMA LLC, SUN PHARMACEUTICAL INDUSTRIES LTD.
Enquiry
Common questions
- Who makes duloxetine hydrochloride?
- 16 companies list duloxetine hydrochloride as a human prescription drug in the openFDA NDC Directory, led by Bryant Ranch Prepack, Proficient Rx LP, Aphena Pharma Solutions - Tennessee, LLC, Golden State Medical Supply Inc., Breckenridge Pharmaceutical, 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 Cymbalta?
- 15 companies list duloxetine hydrochloride 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 duloxetine hydrochloride active ingredient?
- 12 companies list duloxetine hydrochloride as a bulk ingredient, including Aurobindo Pharma Limited, Dr. Reddy's Laboratories Limited, Evonik Operations GmbH, MSN Laboratories Private Limited,.