Active ingredient
Codeine
6 finished FDA listings contain Codeine as their only active ingredient; 110 combination products also contain it.
FDA NDC Directory
- Ingredient names as written by FDA
- CODEINE PHOSPHATE, CODEINE SULFATE
- Dosage forms
- Tablet
- Routes
- Oral
- Manufacturers / labelers
- 2
- Strengths listed
- 15 mg/1 · 30 mg/1 · 60 mg/1
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 2670
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 022402 | HIKMA | 2009-07-16 | 3 |
| ANDA 203046 | LANNETT CO INC | 2014-06-13 | 3 |
Official labeling on DailyMed
- CODEINE SULFATE TABLET [LANNETT COMPANY, INC.] · version 29 · 2026-02-05
- CODEINE SULFATE TABLET [HIKMA PHARMACEUTICALS USA INC.] · version 25 · 2025-12-31
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.