Active ingredient
Demeclocycline
10 finished FDA listings contain Demeclocycline as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- DEMECLOCYCLINE HYDROCHLORIDE
- Dosage forms
- Tablet, Tablet, Film Coated
- Routes
- Oral
- Manufacturers / labelers
- 5
- Strengths listed
- 150 mg/1 · 300 mg/1
- Brand names in FDA listings
- Demeclocycline Hydrochloride
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 3154
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 065425 | AMNEAL PHARM | 2008-02-27 | 6 |
| ANDA 065447 | EPIC PHARMA LLC | 2015-08-18 | 4 |
Official labeling on DailyMed
- DEMECLOCYCLINE HYDROCHLORIDE (DEMECLOCYCLINE) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK LLC] · version 4 · 2026-06-30
- DEMECLOCYCLINE HYDROCHLORIDE TABLET, FILM COATED [PURACAP LABORATORIES LLC] · version 6 · 2025-12-12
- DEMECLOCYCLINE HYDROCHLORIDE (DEMECLOCYCLINE) TABLET [AMNEAL PHARMACEUTICALS LLC] · version 14 · 2024-10-28
- DEMECLOCYCLINE HYDROCHLORIDE (DEMECLOCYCLINE) TABLET [AMERICAN HEALTH PACKAGING] · version 4 · 2024-09-27
- DEMECLOCYCLINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC] · version 8 · 2023-12-21
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.