Application 050730

Type: NDA
Sponsor: PFIZER

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ZITHROMAX	AZITHROMYCIN	TABLET;ORAL	EQ 600MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N050730-001	ZITHROMAX	AZITHROMYCIN	EQ 600MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-06-12

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N050730-001	ZITHROMAX	EQ 600MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-06-12	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N050730-001	ZITHROMAX	EQ 600MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-06-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N050730-001	ZITHROMAX	EQ 600MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-06-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050730-001	ZITHROMAX	EQ 600MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-06-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050730-001	ZITHROMAX	EQ 600MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-06-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050730-001	ZITHROMAX	EQ 600MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-06-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050730-001	ZITHROMAX	EQ 600MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-06-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050730-001	ZITHROMAX	EQ 600MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-06-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050730-001	ZITHROMAX	EQ 600MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-06-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050730-001	ZITHROMAX	EQ 600MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-06-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050730-001	ZITHROMAX	EQ 600MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-06-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050730-001	ZITHROMAX	EQ 600MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-06-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050730-001	ZITHROMAX	EQ 600MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-06-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050730-001	ZITHROMAX	EQ 600MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-06-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050730-001	ZITHROMAX	EQ 600MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-06-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050730-001	ZITHROMAX	EQ 600MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-06-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050730-001	ZITHROMAX	EQ 600MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-06-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050730-001	ZITHROMAX	EQ 600MG BASE	TABLET / ORAL		RLD	1996-06-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050730-001	ZITHROMAX	EQ 600MG BASE	TABLET / ORAL		RLD	1996-06-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050730-001	ZITHROMAX	EQ 600MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL		RLD	1996-06-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050730-001	ZITHROMAX	EQ 600MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-06-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050730-001	ZITHROMAX	EQ 600MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL		RLD	1996-06-12	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050730-001	ZITHROMAX	EQ 600MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL		RLD	1996-06-12	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050730-001	ZITHROMAX	EQ 600MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL		RLD	1996-06-12	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050730-001	ZITHROMAX	EQ 600MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL		RLD	1996-06-12	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050730-001	ZITHROMAX	EQ 600MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL		RLD	1996-06-12	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050730-001	ZITHROMAX	EQ 600MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL		RLD	1996-06-12	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050730-001	ZITHROMAX	EQ 600MG BASE	TABLET / ORAL		RLD	1996-06-12	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050730-001	ZITHROMAX	EQ 600MG BASE	TABLET / ORAL	AB	RLD, RS	1996-06-12	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050730-001	ZITHROMAX	EQ 600MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-06-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N050730-001	ZITHROMAX	EQ 600MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-06-12	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N050730-001	ZITHROMAX	EQ 600MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-06-12	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050730-001	ZITHROMAX	EQ 600MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-06-12	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050730-001	ZITHROMAX	EQ 600MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-06-12	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050730-001	ZITHROMAX	EQ 600MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-06-12	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050730-001	ZITHROMAX	EQ 600MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-06-12	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N050730-001	ZITHROMAX	EQ 600MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-06-12	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N050730-001	ZITHROMAX	EQ 600MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-06-12	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050730-001	ZITHROMAX	EQ 600MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-06-12	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N050730-001	ZITHROMAX	EQ 600MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-06-12	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-07-19 19:46 UTC	2019-07	N050730-001	AB	1	`ea99ee380514…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 6 · 107 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Azithromycin	AZITHROMYCIN	NuCare Pharmaceuticals,Inc.	94e17ae5-0871-67a0-e053-2995a90ae0ae	2026-09-09	Warnings, Adverse reactions	Name fallback generic name: AZITHROMYCIN
azithromycin	AZITHROMYCIN	REMEDYREPACK INC.	da399401-1ee6-422a-be46-0bba6b264b2f	2026-09-08	Warnings, Adverse reactions	Name fallback generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	Aurobindo Pharma Limited	3c902990-b870-4725-b9fe-76b8be633e1c	2026-09-03	Warnings, Adverse reactions	Name fallback generic name: AZITHROMYCIN
azithromycin	AZITHROMYCIN	Major Pharmaceuticals	814abe38-da4a-48af-bf4b-2ce04a5aabd1	2026-09-02	Warnings, Adverse reactions	Name fallback generic name: AZITHROMYCIN
azithromycin	AZITHROMYCIN	REMEDYREPACK INC.	bf061799-cdef-40f8-b1ce-bc5eb609f8c3	2026-09-02	Warnings, Adverse reactions	Name fallback generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	Aurobindo Pharma Limited	795c13cd-e9ca-481b-9fa9-2890bdf9dac8	2026-09-02	Warnings, Adverse reactions	Name fallback generic name: AZITHROMYCIN
azithromycin	AZITHROMYCIN	Lupin Pharmaceuticals, Inc.	01649d79-4677-4577-a3e4-e054f3f9fc3b	2026-08-20	Warnings, Adverse reactions	Name fallback generic name: AZITHROMYCIN
azithromycin	AZITHROMYCIN	Lupin Pharmaceuticals, Inc.	c9990a1d-5238-403e-9221-72a9314d7b5e	2026-08-20	Warnings, Adverse reactions	Name fallback generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	Zydus Pharmaceuticals USA Inc.	99e5bd22-a721-4e2e-a46c-d61a53c25c3d	2026-08-14	Warnings, Adverse reactions	Name fallback generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	REMEDYREPACK INC.	614cc2a4-3fc7-455d-9e8a-212c496f0fbf	2026-08-05	Warnings, Adverse reactions	Name fallback generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	Sandoz Inc	34b70c23-92a6-460f-8dbb-15a0e6b9d3a9	2026-07-30	Warnings, Adverse reactions	Name fallback generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	NuCare Pharmaceuticals,Inc.	a9cdb5ae-2aeb-c598-e053-2a95a90a8062	2026-07-30	Warnings, Adverse reactions	Name fallback generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	Sandoz Inc	ec619299-e0ef-44dd-acdb-8c53bbfc5b8a	2026-07-30	Warnings, Adverse reactions	Name fallback generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	A-S Medication Solutions	882f71b1-b153-4856-b4a7-1a29ae9cf247	2026-07-29	Warnings, Adverse reactions	Name fallback generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	Eugia US LLC	7b81436e-d14a-4353-a22d-253f45e2e576	2026-07-27	Warnings, Adverse reactions	Name fallback generic name: AZITHROMYCIN
Zithromax	AZITHROMYCIN DIHYDRATE	Pfizer Laboratories Div Pfizer Inc	db52b91e-79f7-4cc1-9564-f2eee8e31c45	2026-07-24	Warnings, Adverse reactions	Name fallback brand name: Zithromax
Azithromycin	AZITHROMYCIN	REMEDYREPACK INC.	5f144e92-c9eb-420a-9bb8-4265a9f20a98	2026-07-24	Warnings, Adverse reactions	Name fallback generic name: AZITHROMYCIN
Zithromax	AZITHROMYCIN DIHYDRATE	Pfizer Laboratories Div Pfizer Inc	3b631aa1-2d46-40bc-a614-d698301ea4f9	2026-07-24	Warnings, Adverse reactions	Name fallback brand name: Zithromax
Azithromycin	AZITHROMYCIN	A-S Medication Solutions	3b7e16b1-9a3c-4e3a-8411-841a708afe45	2026-07-23	Warnings, Adverse reactions	Name fallback generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	A-S Medication Solutions	58308e8b-57bd-4e82-a2e8-24aac63194cd	2026-07-23	Warnings, Adverse reactions	Name fallback generic name: AZITHROMYCIN

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0069-3080	ZITHROMAX	AZITHROMYCIN DIHYDRATE	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3080	ZITHROMAX	AZITHROMYCIN DIHYDRATE	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3080	ZITHROMAX	AZITHROMYCIN DIHYDRATE	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3080	ZITHROMAX	AZITHROMYCIN DIHYDRATE	Pfizer Laboratories Div P	NDA	Current
59762-3080	azithromycin	AZITHROMYCIN	Greenstone LLC	NDA	Current
59762-3080	azithromycin	AZITHROMYCIN	Greenstone LLC	NDA	Current
59762-3080	azithromycin	AZITHROMYCIN	Greenstone LLC	NDA	Current
59762-3080	azithromycin	AZITHROMYCIN	Greenstone LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
69393	SUPPL	2021-11-23
69374	SUPPL	2021-11-22
58433	SUPPL	2019-04-26
58414	SUPPL	2019-04-25
47837	SUPPL	2017-04-03
47784	SUPPL	2017-03-30
47184	SUPPL	2017-02-13
47183	SUPPL	2017-02-10
30400	SUPPL	2016-05-25
18139	SUPPL	2016-05-25
8137	SUPPL	2014-06-11
39208	SUPPL	2014-06-10
23725	ORIG	2013-03-12
39210	SUPPL	2013-02-21
8139	SUPPL	2013-02-21
39207	SUPPL	2012-11-06
30399	SUPPL	2012-11-06
39209	SUPPL	2012-06-11
8138	SUPPL	2012-06-08
18138	SUPPL	2011-02-04
30398	SUPPL	2011-02-03
39206	SUPPL	2010-08-19
8136	SUPPL	2010-08-17
39205	SUPPL	2009-04-23
8135	SUPPL	2009-03-10
8134	SUPPL	2007-11-08
39204	SUPPL	2007-11-07
39203	SUPPL	2004-04-05
30396	SUPPL	2004-03-28
30397	SUPPL	2004-01-22
30395	SUPPL	2002-10-16
8133	SUPPL	2002-07-22
39202	SUPPL	2000-11-13
30394	SUPPL	2000-11-13
22210	SUPPL	2000-11-13