Active ingredient
Hydrocodone
19 finished FDA listings contain Hydrocodone as their only active ingredient; 226 combination products also contain it.
FDA NDC Directory
- Ingredient names as written by FDA
- HYDROCODONE, HYDROCODONE BITARTRATE
- Dosage forms
- Capsule, Extended Release, Tablet, Extended Release
- Routes
- Oral
- Manufacturers / labelers
- 2
- Strengths listed
- 10 mg/1 · 100 mg/1 · 120 mg/1 · 15 mg/1 · 20 mg/1 · 30 mg/1 · 40 mg/1 · 50 mg/1 · 60 mg/1 · 80 mg/1
- Brand names in FDA listings
- Hysingla Er
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 5489
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 206627 | KNOA PHARMA | 2014-11-20 | 6 |
| ANDA 206986 | ALVOGEN | 2020-01-21 | 6 |
| ANDA 208269 | ALVOGEN | 2021-03-01 | 7 |
Official labeling on DailyMed
- HYSINGLA ER (HYDROCODONE BITARTRATE) TABLET, EXTENDED RELEASE [KNOA PHARMA LLC] · version 17 · 2026-06-18
- HYDROCODONE BITARTRATE TABLET, EXTENDED RELEASE [ALVOGEN INC.] · version 8 · 2026-05-28
- HYDROCODONE BITARTRATE CAPSULE, EXTENDED RELEASE [ALVOGEN INC.] · version 9 · 2025-11-17
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.