Active ingredient
Minocycline
130 finished FDA listings contain Minocycline as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- MINOCYCLINE, MINOCYCLINE HYDROCHLORIDE
- Dosage forms
- Aerosol, Foam, Capsule, Injection, Powder, Tablet, Tablet, Extended Release, Tablet, Film Coated, Tablet, Film Coated, Extended Release
- Routes
- Intravenous, Oral, Topical
- Manufacturers / labelers
- 24
- Strengths listed
- 1 mg/1 · 100 mg/1 · 105 mg/1 · 115 mg/1 · 135 mg/1 · 15 mg/g · 40 mg/1 · 40 mg/g · 45 mg/1 · 50 mg/1 · 55 mg/1 · 65 mg/1 · 75 mg/1 · 80 mg/1 · 90 mg/1
- Brand names in FDA listings
- Amzeeq, Arestin, Emrosi, Minocin, Zilxi
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 6980
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 050444 | REMPEX | 1972-10-26 | 1 |
| ANDA 063181 | WATSON LABS TEVA | 1991-12-30 | 3 |
| ANDA 063065 | WATSON LABS | 1991-12-30 | 5 |
| ANDA 063011 | ZYDUS | 1992-03-02 | 3 |
| ANDA 063009 | ZYDUS | 1992-03-02 | 5 |
| ANDA 065062 | TORRENT | 2000-11-30 | 16 |
| NDA 050781 | ORAPHARMA | 2001-02-16 | 1 |
| ANDA 065131 | STRIDES PHARMA INTL | 2003-04-16 | 3 |
| ANDA 065156 | TORRENT | 2004-01-06 | 4 |
| ANDA 065436 | CHARTWELL RX | 2007-12-26 | 3 |
| ANDA 065470 | AUROBINDO PHARMA | 2008-03-11 | 14 |
| ANDA 091424 | LUPIN | 2011-11-30 | 4 |
| ANDA 202261 | AUROBINDO PHARMA LTD | 2012-11-19 | 8 |
| ANDA 090867 | SUN PHARM INDS INC | 2013-05-13 | 2 |
| ANDA 204453 | ALKEM LABS LTD | 2016-09-28 | 36 |
| ANDA 203553 | ZYDUS PHARMS | 2017-11-16 | 16 |
| NDA 212379 | JOURNEY | 2019-10-18 | 1 |
| ANDA 213662 | AUROBINDO PHARMA LTD | 2020-05-01 | 3 |
| NDA 213690 | JOURNEY | 2020-05-28 | 1 |
| NDA 219015 | JOURNEY | 2024-11-01 | 1 |
Official labeling on DailyMed
- MINOCYCLINE HYDROCHLORIDE CAPSULE [ACTAVIS PHARMA, INC.] · version 24 · 2026-08-11
- MINOCYCLINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.] · version 23 · 2026-08-04
- MINOCYCLINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.] · version 3 · 2026-08-04
- MINOCYCLINE HYDROCHLORIDE CAPSULE [MAJOR PHARAMCEUTICALS] · version 6 · 2026-07-28
- MINOCYCLINE HYDROCHLORIDE CAPSULE [PREFERRED PHARMACEUTICALS INC.] · version 9 · 2026-07-10
- MINOCYCLINE HYDROCHLORIDE CAPSULE [REMEDYREPACK INC.] · version 17 · 2026-07-06
- MINOCYCLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK] · version 101 · 2026-06-29
- MINOCYCLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK] · version 12 · 2026-06-26
- MINOCYCLINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.] · version 28 · 2026-06-15
- MINOCYCLINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.] · version 28 · 2026-06-15
- MINOCYCLINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.] · version 27 · 2026-05-15
- MINOCYCLINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK] · version 101 · 2026-05-06
Showing the 12 most recent of 73 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.