Active ingredient
Levorphanol
10 finished FDA listings contain Levorphanol as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- LEVORPHANOL TARTRATE
- Dosage forms
- Tablet
- Routes
- Oral
- Manufacturers / labelers
- 7
- Strengths listed
- 2 mg/1 · 3 mg/1
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 6378
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 |
|---|---|---|---|
| ANDA 074278 | HIKMA | 2000-03-31 | 1 |
| ANDA 211484 | ACERTIS PHARMS | 2018-12-13 | 3 |
| ANDA 212024 | SPECGX LLC | 2019-12-13 | 1 |
| ANDA 213479 | NOVITIUM PHARMA | 2020-07-01 | 3 |
| ANDA 213906 | SUN PHARM INDS INC | 2021-06-17 | 2 |
Official labeling on DailyMed
- LEVORPHANOL TARTRATE TABLET [SPECGX LLC] · version 18 · 2026-05-01
- LEVORPHANOL TARTRATE TABLET [BRYANT RANCH PREPACK] · version 106 · 2026-04-02
- LEVORPHANOL TARTRATE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] · version 10 · 2026-01-26
- LEVORPHANOL TARTRATE TABLET [LANNETT COMPANY, INC.] · version 7 · 2026-01-16
- LEVORPHANOL TARTRATE TABLET [HIKMA PHARMACEUTICALS USA INC.] · version 17 · 2026-01-08
- LEVORPHANOL TARTRATE TABLET [BRYANT RANCH PREPACK] · version 102 · 2025-11-17
- LEVORPHANOL TARTRATE TABLET [VIRTUS PHARMACEUTICALS, LLC] · version 4 · 2025-08-04
- LEVORPHANOL TARTRATE TABLET [ACERTIS PHARMACEUTICALS, LLC] · version 1 · 2025-07-14
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.