Active ingredient
Azithromycin
205 finished FDA listings contain Azithromycin as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- AZITHROMYCIN DIHYDRATE, AZITHROMYCIN MONOHYDRATE
- Dosage forms
- Injection, Powder, Lyophilized, For Solution, Powder, For Suspension, Solution/ Drops, Suspension, Tablet, Tablet, Film Coated
- Routes
- Intravenous, Ophthalmic, Oral, Parenteral
- Manufacturers / labelers
- 57
- Strengths listed
- 10 mg/ml · 100 mg/5ml · 200 mg/5ml · 250 mg/1 · 500 mg/1 · 500 mg/10ml · 500 mg/5ml · 600 mg/1
- Brand names in FDA listings
- Azasite, Azithromycin, Zithromax
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 18631
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 050710 | PFIZER | 1995-10-19 | 3 |
| NDA 050711 | PFIZER | 1996-07-18 | 3 |
| NDA 050733 | PFIZER | 1997-01-30 | 2 |
| NDA 050784 | PFIZER | 2002-05-24 | 1 |
| ANDA 065218 | PLIVA | 2005-11-14 | 2 |
| ANDA 065212 | SANDOZ | 2005-11-14 | 3 |
| ANDA 065225 | PLIVA | 2005-11-14 | 7 |
| ANDA 065209 | SANDOZ | 2005-11-14 | 1 |
| ANDA 065211 | SANDOZ | 2005-11-14 | 5 |
| ANDA 065223 | PLIVA | 2005-11-14 | 5 |
| ANDA 065179 | FRESENIUS KABI USA | 2005-12-13 | 2 |
| ANDA 065246 | PLIVA | 2006-07-06 | 8 |
| NDA 050810 | THEA PHARMA | 2007-04-27 | 1 |
| ANDA 065501 | GLAND PHARMA LTD | 2009-11-09 | 6 |
| ANDA 090923 | SUN PHARM INDS LTD | 2013-04-02 | 1 |
| ANDA 065488 | CHARTWELL RX | 2015-05-15 | 2 |
| ANDA 065398 | LUPIN | 2015-05-15 | 8 |
| ANDA 065399 | LUPIN | 2015-05-15 | 5 |
| ANDA 065400 | LUPIN | 2015-05-15 | 2 |
| ANDA 203294 | EUGIA PHARMA | 2015-06-19 | 1 |
| ANDA 207531 | EPIC PHARMA LLC | 2018-04-09 | 17 |
| ANDA 207370 | AUROBINDO PHARMA LTD | 2018-07-05 | 12 |
| ANDA 207398 | AUROBINDO PHARMA LTD | 2018-07-05 | 15 |
| ANDA 211147 | ZYDUS LIFESCIENCES | 2018-07-31 | 14 |
| ANDA 207566 | CSPC OUYI | 2018-09-24 | 2 |
| ANDA 203412 | HAINAN POLY | 2018-10-09 | 1 |
| ANDA 209201 | AUROBINDO PHARMA LTD | 2018-10-09 | 2 |
| ANDA 208249 | CSPC OUYI | 2018-10-25 | 20 |
| ANDA 209045 | SUNSHINE | 2018-12-07 | 2 |
| ANDA 209044 | SUNSHINE | 2018-12-07 | 2 |
| ANDA 209999 | BIONPHARMA | 2018-12-26 | 1 |
| ANDA 210001 | BIONPHARMA | 2019-02-26 | 6 |
| ANDA 210000 | BIONPHARMA | 2019-02-26 | 8 |
| ANDA 208250 | CSPC OUYI | 2019-04-17 | 18 |
| ANDA 211793 | ALEMBIC | 2020-01-27 | 2 |
| ANDA 211791 | ALEMBIC | 2020-01-28 | 2 |
| ANDA 211792 | ALEMBIC | 2020-01-28 | 3 |
| ANDA 217036 | ZHEJIANG POLY PHARM | 2023-07-27 | 10 |
Official labeling on DailyMed
- AZITHROMYCIN TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.] · version 6 · 2026-09-11
- AZITHROMYCIN TABLET, FILM COATED [MAJOR PHARMACEUTICALS] · version 7 · 2026-09-11
- AZITHROMYCIN TABLET, FILM COATED [REMEDYREPACK INC.] · version 4 · 2026-09-10
- AZITHROMYCIN POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED] · version 9 · 2026-09-09
- AZITHROMYCIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] · version 9 · 2026-09-08
- AZITHROMYCIN TABLET, FILM COATED [REMEDYREPACK INC.] · version 4 · 2026-09-03
- AZITHROMYCIN TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] · version 6 · 2026-09-02
- AZITHROMYCIN DIHYDRATE TABLET, FILM COATED [REMEDYREPACK INC.] · version 3 · 2026-09-02
- AZITHROMYCIN TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] · version 10 · 2026-09-02
- AZITHROMYCIN DIHYDRATE TABLET, FILM COATED [REMEDYREPACK INC.] · version 7 · 2026-08-31
- AZITHROMYCIN TABLET, FILM COATED [SANDOZ INC] · version 5 · 2026-08-20
- AZITHROMYCIN POWDER, FOR SUSPENSION [ZYDUS PHARMACEUTICALS USA INC.] · version 8 · 2026-08-20
Showing the 12 most recent of 156 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.