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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.

ApplicationSponsorOriginal approvalListings
NDA 050710PFIZER1995-10-193
NDA 050711PFIZER1996-07-183
NDA 050733PFIZER1997-01-302
NDA 050784PFIZER2002-05-241
ANDA 065218PLIVA2005-11-142
ANDA 065212SANDOZ2005-11-143
ANDA 065225PLIVA2005-11-147
ANDA 065209SANDOZ2005-11-141
ANDA 065211SANDOZ2005-11-145
ANDA 065223PLIVA2005-11-145
ANDA 065179FRESENIUS KABI USA2005-12-132
ANDA 065246PLIVA2006-07-068
NDA 050810THEA PHARMA2007-04-271
ANDA 065501GLAND PHARMA LTD2009-11-096
ANDA 090923SUN PHARM INDS LTD2013-04-021
ANDA 065488CHARTWELL RX2015-05-152
ANDA 065398LUPIN2015-05-158
ANDA 065399LUPIN2015-05-155
ANDA 065400LUPIN2015-05-152
ANDA 203294EUGIA PHARMA2015-06-191
ANDA 207531EPIC PHARMA LLC2018-04-0917
ANDA 207370AUROBINDO PHARMA LTD2018-07-0512
ANDA 207398AUROBINDO PHARMA LTD2018-07-0515
ANDA 211147ZYDUS LIFESCIENCES2018-07-3114
ANDA 207566CSPC OUYI2018-09-242
ANDA 203412HAINAN POLY2018-10-091
ANDA 209201AUROBINDO PHARMA LTD2018-10-092
ANDA 208249CSPC OUYI2018-10-2520
ANDA 209045SUNSHINE2018-12-072
ANDA 209044SUNSHINE2018-12-072
ANDA 209999BIONPHARMA2018-12-261
ANDA 210001BIONPHARMA2019-02-266
ANDA 210000BIONPHARMA2019-02-268
ANDA 208250CSPC OUYI2019-04-1718
ANDA 211793ALEMBIC2020-01-272
ANDA 211791ALEMBIC2020-01-282
ANDA 211792ALEMBIC2020-01-283
ANDA 217036ZHEJIANG POLY PHARM2023-07-2710

Official labeling on DailyMed

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.