Drug
Who makes hydrocodone bitartrate?
2 companies list hydrocodone bitartrate as a human prescription drug, including under the names Hysingla ER. Forms: capsule, extended release; tablet, extended release. 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 hydrocodone bitartrate
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Alvogen, Inc. | capsule, extended release; tablet, extended release | ANDAANDA206986, ANDA208269 | 13 | 0 |
| Knoa Pharma LLCUnited States | tablet, extended release | NDANDA206627 | 6 | 1 |
Bulk ingredient listings
- Cambrex Charles City, Inc. · 2 NDC
- Chattem Chemicals, Inc.United States · 1 NDC
- LETCO MEDICAL, LLCUnited States · 1 NDC
- MEDISCA Inc.United States · 1 NDC
- Noramco, LLCUnited States · 1 NDC
- Pharma Source Direct, LLCUnited States · 1 NDC
- Professional Compounding Centers of America dba PCCAUnited States · 1 NDC
- Siegfried USA, LLCUnited States · 1 NDC
- SpecGx LLCUnited States · 1 NDC
- Spectrum Pharmaceuticals, Inc.United States · 1 NDC
- Veranova, L.P.United States · 1 NDC
Orange Book patents
38 unexpired patents list hydrocodone bitartrate as the active ingredient, expiring between Aug 2027 and Sept 2034. Application holders: KNOA PHARMA LLC, RECRO GAINESVILLE LLC, TEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D INC.
Enquiry
Common questions
- Who makes hydrocodone bitartrate?
- 2 companies list hydrocodone bitartrate as a human prescription drug in the openFDA NDC Directory, led by Alvogen, Inc., Knoa Pharma 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 Hysingla ER?
- 1 company lists hydrocodone bitartrate 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 hydrocodone bitartrate active ingredient?
- 11 companies list hydrocodone bitartrate as a bulk ingredient, including Cambrex Charles City, Inc., Chattem Chemicals, Inc., LETCO MEDICAL, LLC, MEDISCA Inc..