Active ingredient
Doxycycline
334 finished FDA listings contain Doxycycline as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- DOXYCYCLINE, DOXYCYCLINE ANHYDROUS, DOXYCYCLINE HYCLATE
- Dosage forms
- Capsule, For Suspension, Injection, Powder, For Solution, Injection, Powder, Lyophilized, For Solution, Powder, For Solution, Powder, For Suspension, Tablet, Tablet, Coated, Tablet, Delayed Release, Tablet, Film Coated
- Routes
- Intravenous, Oral
- Manufacturers / labelers
- 93
- Strengths listed
- 100 mg/1 · 100 mg/100mg · 100 mg/10ml · 150 mg/1 · 20 mg/1 · 200 mg/1 · 200 mg/20ml · 25 mg/5ml · 40 mg/1 · 50 mg/1 · 60 mg/1 · 75 mg/1
- Brand names in FDA listings
- Acticlate Cap, Doryx Mpc, Doxy 100, Doxycyclate Hyclate, Doxycycline, Doxycycline Doxycycline, Doxycycline Hyclate, Doxycycline Hyclate Delayed Release, Oracea, Targadox
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 3640
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 062269 | EPIC PHARMA LLC | 1982-11-08 | 12 |
| ANDA 062475 | FRESENIUS KABI USA | 1983-12-09 | 4 |
| ANDA 062505 | CHARTWELL | 1984-09-11 | 11 |
| ANDA 062500 | CHARTWELL | 1984-09-11 | 19 |
| ANDA 062396 | HIKMA INTL PHARMS | 1984-11-07 | 18 |
| ANDA 062676 | SUN PHARM INDUSTRIES | 1986-07-10 | 14 |
| ANDA 062677 | SUN PHARM INDUSTRIES | 1986-07-10 | 6 |
| NDA 050641 | CHARTWELL RX | 1989-12-29 | 5 |
| ANDA 065053 | SUN PHARM INDS LTD | 2000-11-22 | 5 |
| ANDA 065055 | STRIDES PHARMA INTL | 2000-12-01 | 16 |
| ANDA 065070 | STRIDES PHARMA INTL | 2000-12-15 | 4 |
| ANDA 065095 | HIKMA INTL PHARMS | 2003-07-02 | 10 |
| ANDA 065182 | EPIC PHARMA LLC | 2005-05-13 | 3 |
| ANDA 065285 | LANNETT CO INC | 2005-12-08 | 6 |
| ANDA 065356 | SUN PHARM INDS LTD | 2006-05-31 | 4 |
| ANDA 065454 | CHARTWELL | 2008-07-16 | 3 |
| ANDA 091605 | HERITAGE | 2011-12-20 | 9 |
| ANDA 091406 | MYLAN LABS LTD | 2012-08-21 | 2 |
| ANDA 200856 | HERITAGE | 2013-04-30 | 4 |
| ANDA 204234 | LUPIN | 2014-03-05 | 5 |
| NDA 205931 | CHARTWELL RX | 2014-07-25 | 2 |
| ANDA 204446 | COSETTE PHARMS NC | 2015-05-28 | 4 |
| ANDA 205115 | ZYDUS PHARMS | 2016-02-18 | 17 |
| NDA 208253 | CHARTWELL RX | 2016-04-26 | 2 |
| ANDA 207289 | AMNEAL PHARMS | 2016-06-27 | 5 |
| ANDA 207494 | PRINSTON INC | 2016-11-15 | 4 |
| ANDA 209165 | ALEMBIC | 2017-07-28 | 6 |
| ANDA 207558 | NOVEL LABS INC | 2017-09-06 | 2 |
| ANDA 208818 | LUPIN | 2017-09-27 | 2 |
| ANDA 207757 | ZYDUS PHARMS | 2017-09-28 | 4 |
| ANDA 209582 | ZYDUS PHARMS | 2017-09-28 | 12 |
| ANDA 207773 | ZYDUS LIFESCIENCES | 2017-10-30 | 5 |
| ANDA 207774 | ZYDUS LIFESCIENCES | 2018-05-31 | 13 |
| ANDA 210527 | ALEMBIC | 2018-06-13 | 4 |
| ANDA 209402 | CHANGZHOU PHARM | 2019-10-07 | 13 |
| ANDA 211343 | CHANGZHOU PHARM | 2019-10-09 | 12 |
| ANDA 210536 | ALEMBIC | 2020-05-14 | 4 |
| ANDA 211744 | ALEMBIC | 2020-06-30 | 4 |
| ANDA 213075 | ALEMBIC | 2022-01-03 | 8 |
| ANDA 215583 | GLAND | 2023-04-12 | 4 |
Showing 40 of 73 applications.
Official labeling on DailyMed
- DOXYCYCLINE HYCLATE TABLET, FILM COATED [REMEDYREPACK INC.] · version 2 · 2026-09-16
- DOXYCYCLINE HYCLATE CAPSULE [A-S MEDICATION SOLUTIONS] · version 10 · 2026-09-10
- DOXYCYCLINE HYCLATE CAPSULE [HAWAII REPACK, INC] · version 2 · 2026-09-10
- DOXYCYCLINE HYCLATE TABLET [NUCARE PHARMACEUTICALS,INC.] · version 5 · 2026-09-07
- DOXYCYCLINE HYCLATE TABLET [REMEDYREPACK INC.] · version 16 · 2026-09-02
- DOXYCYCLINE HYCLATE CAPSULE [REMEDYREPACK INC.] · version 5 · 2026-08-31
- DOXYCYCLINE (DOXYCYCLINE HYCLATE) TABLET, COATED [REMEDYREPACK INC.] · version 7 · 2026-08-28
- DOXYCYCLINE CAPSULE [PROFICIENT RX LP] · version 3 · 2026-08-28
- DOXYCYCLINE (DOXYCYCLINE HYCLATE) TABLET, COATED [ACELLA PHARMACEUTICALS, LLC] · version 9 · 2026-08-20
- DOXYCYCLINE CAPSULE [COUPLER LLC] · version 1 · 2026-08-20
- DOXYCYCLINE HYCLATE TABLET, COATED [MAJOR PHARMACEUTICALS] · version 16 · 2026-08-20
- DOXYCYCLINE CAPSULE [NUCARE PHARMACEUTICALS,INC.] · version 3 · 2026-08-19
Showing the 12 most recent of 239 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.