Azithromycin

Treats mild to moderate infections caused by susceptible strains of the designated…. Sold as Zithromax, Zmax, Azithromycin, Azasite. Every FDA application for this active ingredient: 10 branded and 64 generic.

As of Nov 13, 2026, FDA lists 74 applications for Azithromycin (sold as Zithromax, Zmax, Azithromycin and others), first approved Nov 1, 1991, with 10 new uses approved and 0 published complete response letters.

First approved: Nov 1, 1991
Applications: 74
New uses approved: 10
Complete response letters: 0
Medicare spending, 2025: $47.9M

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name

Product	Part	Spending, 2025	Change	Beneficiaries
Azithromycin	Part D	$46.4M	+2%	6,517,302
Azasite	Part D	$1.5M	-5%	2,937
Zithromax	Part D	$10K	-53%	261
Azithromycin	Part B	$2K	-26%	404

Shortages

FDA's drug shortage list, as of Nov 13, 2026

Shortage	Status	First posted	Updated
Azithromycin Tablet	To Be Discontinued	Apr 9, 2026	Apr 9, 2026
Azithromycin Injection	To Be Discontinued	Jan 20, 2026	Jan 20, 2026

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history

Approved	Application	Sponsor	Supplements	Marketing
Nov 1, 1991	ZithromaxNDA 50670 · New molecular entity	Pfizer	22	Discontinued
Sep 28, 1994	ZithromaxNDA 50693 · New dosage form	Pfizer	21	Discontinued
Oct 19, 1995	ZithromaxNDA 50710 · New dosage form	Pfizer	31	Marketed
Jun 12, 1996	ZithromaxNDA 50730 · New dosage form	Pfizer	24	Discontinued
Jul 18, 1996	ZithromaxNDA 50711 · New dosage form	Pfizer	29	Marketed
Jan 30, 1997	ZithromaxNDA 50733 · New dosage form	Pfizer	28	Discontinued
May 24, 2002	ZithromaxNDA 50784 · New dosage form	Pfizer	19	Marketed
Jun 10, 2005	ZmaxNDA 50797 · New dosage form	Pf Prism Cv	15	Discontinued
Nov 14, 2005	AzithromycinANDA 65153	Teva	14	Discontinued
Nov 14, 2005	AzithromycinANDA 65193	Teva	15	Marketed
Nov 14, 2005	AzithromycinANDA 65212	Sandoz	15	Marketed
Nov 14, 2005	AzithromycinANDA 65150	Teva	14	Discontinued
Nov 14, 2005	AzithromycinANDA 65209	Sandoz	14	Marketed
Nov 14, 2005	AzithromycinANDA 65211	Sandoz	13	Marketed
Nov 14, 2005	AzithromycinANDA 65218	Pliva	8	Marketed
Nov 14, 2005	AzithromycinANDA 65223	Pliva	8	Marketed
Nov 14, 2005	AzithromycinANDA 65225	Pliva	11	Marketed
Dec 13, 2005	AzithromycinANDA 65179	Fresenius Kabi USA	7	Marketed
Jul 6, 2006	AzithromycinANDA 65246	Pliva	13	Marketed
Sep 18, 2006	AzithromycinANDA 65297	Sandoz	0	Discontinued
Dec 19, 2006	AzithromycinNDA 50809 · New dosage form	Teva Parenteral	0	Discontinued
Jan 8, 2007	AzithromycinANDA 65360	Aurobindo Pharma USA	5	Discontinued
Jan 18, 2007	AzithromycinANDA 65265	Hikma	2	Discontinued
Apr 27, 2007	AzasiteNDA 50810 · New dosage form	Thea Pharma	9	Marketed
May 30, 2007	AzithromycinANDA 65365	Pharmobedient	4	Discontinued
May 30, 2007	AzithromycinANDA 65366	Extrovis	4	Discontinued
Feb 11, 2008	AzithromycinANDA 65302	Chartwell Rx	7	Marketed
Feb 11, 2008	AzithromycinANDA 65404	Chartwell Rx	8	Marketed
Feb 11, 2008	AzithromycinANDA 65405	Chartwell Rx	7	Marketed
Jun 24, 2008	AzithromycinANDA 65419	Teva Pharms	10	Discontinued
Mar 24, 2009	AzithromycinANDA 65506	Pharmobedient	10	Discontinued
Jun 26, 2009	AzithromycinANDA 65500	Hospira	6	Marketed
Jun 26, 2009	AzithromycinANDA 65511	Hospira	6	Discontinued
Nov 9, 2009	AzithromycinANDA 65501	Gland Pharma Ltd	8	Marketed
Jul 13, 2011	AzithromycinANDA 65507	Apotex Corp	2	Discontinued
Jul 13, 2011	AzithromycinANDA 65508	Apotex Corp	2	Discontinued
Jul 13, 2011	AzithromycinANDA 65509	Apotex Corp	2	Discontinued
Apr 2, 2013	AzithromycinANDA 90923	Sun Pharm Inds Ltd	5	Discontinued
May 15, 2015	AzithromycinANDA 65398	Lupin	7	Marketed
May 15, 2015	AzithromycinANDA 65399	Lupin	6	Marketed
May 15, 2015	AzithromycinANDA 65400	Lupin	3	Marketed
May 15, 2015	AzithromycinANDA 65488	Chartwell Rx	5	Marketed
Jun 19, 2015	AzithromycinANDA 203294	Eugia Pharma	7	Marketed
Jan 26, 2017	AzithromycinANDA 204732	Rising	1	Discontinued
Apr 9, 2018	AzithromycinANDA 207531	Epic Pharma LLC	2	Marketed
Jul 5, 2018	AzithromycinANDA 207370	Aurobindo Pharma Ltd	2	Marketed
Jul 5, 2018	AzithromycinANDA 207398	Aurobindo Pharma Ltd	2	Marketed
Jul 19, 2018	AzithromycinANDA 205666	Amneal	2	Discontinued
Jul 31, 2018	AzithromycinANDA 211147	Zydus Lifesciences	2	Marketed
Sep 24, 2018	AzithromycinANDA 207566	Cspc Ouyi	2	Marketed
Oct 9, 2018	AzithromycinANDA 203412	Hainan Poly	1	Marketed
Oct 9, 2018	AzithromycinANDA 209201	Aurobindo Pharma Ltd	3	Marketed
Oct 25, 2018	AzithromycinANDA 208249	Cspc Ouyi	1	Marketed
Dec 6, 2018	AzithromycinANDA 209043	Sunshine	2	Marketed
Dec 7, 2018	AzithromycinANDA 209044	Sunshine	4	Marketed
Dec 7, 2018	AzithromycinANDA 209045	Sunshine	4	Marketed
Dec 26, 2018	AzithromycinANDA 209999	Bionpharma	2	Marketed
Feb 26, 2019	AzithromycinANDA 210000	Bionpharma	2	Marketed
Feb 26, 2019	AzithromycinANDA 210001	Bionpharma	3	Marketed
Apr 17, 2019	AzithromycinANDA 208250	Cspc Ouyi	1	Marketed
Dec 11, 2019	AzithromycinANDA 211521	Taro	0	Discontinued
Jan 27, 2020	AzithromycinANDA 211793	Alembic	2	Marketed
Jan 28, 2020	AzithromycinANDA 211791	Alembic	2	Marketed
Jan 28, 2020	AzithromycinANDA 211792	Alembic	2	Marketed
May 8, 2020	AzithromycinANDA 211068	Carlsbad	2	Marketed
Mar 17, 2021	AzithromycinANDA 211318	Fosun Pharma	1	Discontinued
Jul 12, 2022	AzithromycinANDA 215773	Strides Pharma	0	Discontinued
Jul 15, 2022	AzithromycinANDA 215772	Strides Pharma	1	Discontinued
Jul 26, 2022	AzithromycinANDA 211317	Carlsbad	1	Discontinued
Apr 7, 2023	AzithromycinANDA 213056	Zydus Pharms	0	Discontinued
Apr 11, 2023	AzithromycinANDA 213275	Zydus Pharms	0	Discontinued
Jul 27, 2023	AzithromycinANDA 217036	Zhejiang Poly Pharm	0	Marketed
—	AzithromycinANDA 202308	Sandoz Inc	0	Discontinued
—	AzithromycinANDA 202793	Novel Labs Inc	0	Discontinued

Show all 74

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number. Drugs@FDA