Application 050693

Type: NDA
Sponsor: PFIZER

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ZITHROMAX	AZITHROMYCIN	FOR SUSPENSION;ORAL	EQ 1GM BASE/PACKET	Yes	Yes

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
N050693-001	ZITHROMAX	AZITHROMYCIN	EQ 1GM BASE/PACKET	FOR SUSPENSION / ORAL		RLD	1994-09-28

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	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N050693-001	ZITHROMAX	EQ 1GM BASE/PACKET	FOR SUSPENSION / ORAL	RLD	1994-09-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N050693-001	ZITHROMAX	EQ 1GM BASE/PACKET	FOR SUSPENSION / ORAL	RLD	1994-09-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N050693-001	ZITHROMAX	EQ 1GM BASE/PACKET	FOR SUSPENSION / ORAL	RLD	1994-09-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050693-001	ZITHROMAX	EQ 1GM BASE/PACKET	FOR SUSPENSION / ORAL	RLD	1994-09-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050693-001	ZITHROMAX	EQ 1GM BASE/PACKET	FOR SUSPENSION / ORAL	RLD	1994-09-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050693-001	ZITHROMAX	EQ 1GM BASE/PACKET	FOR SUSPENSION / ORAL	RLD, RS	1994-09-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050693-001	ZITHROMAX	EQ 1GM BASE/PACKET	FOR SUSPENSION / ORAL	RLD, RS	1994-09-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050693-001	ZITHROMAX	EQ 1GM BASE/PACKET	FOR SUSPENSION / ORAL	RLD, RS	1994-09-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050693-001	ZITHROMAX	EQ 1GM BASE/PACKET	FOR SUSPENSION / ORAL	RLD, RS	1994-09-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050693-001	ZITHROMAX	EQ 1GM BASE/PACKET	FOR SUSPENSION / ORAL	RLD, RS	1994-09-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050693-001	ZITHROMAX	EQ 1GM BASE/PACKET	FOR SUSPENSION / ORAL	RLD, RS	1994-09-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050693-001	ZITHROMAX	EQ 1GM BASE/PACKET	FOR SUSPENSION / ORAL	RLD, RS	1994-09-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050693-001	ZITHROMAX	EQ 1GM BASE/PACKET	FOR SUSPENSION / ORAL	RLD, RS	1994-09-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050693-001	ZITHROMAX	EQ 1GM BASE/PACKET	FOR SUSPENSION / ORAL	RLD, RS	1994-09-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050693-001	ZITHROMAX	EQ 1GM BASE/PACKET	FOR SUSPENSION / ORAL	RLD, RS	1994-09-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050693-001	ZITHROMAX	EQ 1GM BASE/PACKET	FOR SUSPENSION / ORAL	RLD, RS	1994-09-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050693-001	ZITHROMAX	EQ 1GM BASE/PACKET	FOR SUSPENSION / ORAL	RLD, RS	1994-09-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050693-001	ZITHROMAX	EQ 1GM BASE/PACKET	FOR SUSPENSION / ORAL	RLD, RS	1994-09-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050693-001	ZITHROMAX	EQ 1GM BASE/PACKET	FOR SUSPENSION / ORAL	RLD, RS	1994-09-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050693-001	ZITHROMAX	EQ 1GM BASE/PACKET	FOR SUSPENSION / ORAL	RLD, RS	1994-09-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050693-001	ZITHROMAX	EQ 1GM BASE/PACKET	FOR SUSPENSION / ORAL	RLD, RS	1994-09-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050693-001	ZITHROMAX	EQ 1GM BASE/PACKET	FOR SUSPENSION / ORAL	RLD, RS	1994-09-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050693-001	ZITHROMAX	EQ 1GM BASE/PACKET	FOR SUSPENSION / ORAL	RLD, RS	1994-09-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050693-001	ZITHROMAX	EQ 1GM BASE/PACKET	FOR SUSPENSION / ORAL	RLD, RS	1994-09-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050693-001	ZITHROMAX	EQ 1GM BASE/PACKET	FOR SUSPENSION / ORAL	RLD, RS	1994-09-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050693-001	ZITHROMAX	EQ 1GM BASE/PACKET	FOR SUSPENSION / ORAL	RLD, RS	1994-09-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050693-001	ZITHROMAX	EQ 1GM BASE/PACKET	FOR SUSPENSION / ORAL	RLD, RS	1994-09-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050693-001	ZITHROMAX	EQ 1GM BASE/PACKET	FOR SUSPENSION / ORAL	RLD, RS	1994-09-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050693-001	ZITHROMAX	EQ 1GM BASE/PACKET	FOR SUSPENSION / ORAL	RLD, RS	1994-09-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050693-001	ZITHROMAX	EQ 1GM BASE/PACKET	FOR SUSPENSION / ORAL	RLD, RS	1994-09-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N050693-001	ZITHROMAX	EQ 1GM BASE/PACKET	FOR SUSPENSION / ORAL	RLD, RS	1994-09-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N050693-001	ZITHROMAX	EQ 1GM BASE/PACKET	FOR SUSPENSION / ORAL	RLD, RS	1994-09-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050693-001	ZITHROMAX	EQ 1GM BASE/PACKET	FOR SUSPENSION / ORAL	RLD, RS	1994-09-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050693-001	ZITHROMAX	EQ 1GM BASE/PACKET	FOR SUSPENSION / ORAL	RLD, RS	1994-09-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050693-001	ZITHROMAX	EQ 1GM BASE/PACKET	FOR SUSPENSION / ORAL	RLD, RS	1994-09-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050693-001	ZITHROMAX	EQ 1GM BASE/PACKET	FOR SUSPENSION / ORAL	RLD, RS	1994-09-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N050693-001	ZITHROMAX	EQ 1GM BASE/PACKET	FOR SUSPENSION / ORAL	RLD, RS	1994-09-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N050693-001	ZITHROMAX	EQ 1GM BASE/PACKET	FOR SUSPENSION / ORAL	RLD, RS	1994-09-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050693-001	ZITHROMAX	EQ 1GM BASE/PACKET	FOR SUSPENSION / ORAL	RLD, RS	1994-09-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N050693-001	ZITHROMAX	EQ 1GM BASE/PACKET	FOR SUSPENSION / ORAL	RLD, RS	1994-09-28	`f41ea6bd6efb…`

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 2 of 6 · 104 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Azithromycin	AZITHROMYCIN	Bryant Ranch Prepack	2a8010dc-700f-45d3-94ca-ebe4a51acc1b	2026-07-20	Warnings, Adverse reactions	Name fallback generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	Bryant Ranch Prepack	6caeda98-7020-413a-9461-04f476dad4ba	2026-07-20	Warnings, Adverse reactions	Name fallback generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	A-S Medication Solutions	3c4861f2-825e-4e3b-9907-9658a849079e	2026-07-16	Warnings, Adverse reactions	Name fallback generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	REMEDYREPACK INC.	333ffe63-aaeb-4dff-b595-1c11209189a6	2026-07-01	Warnings, Adverse reactions	Name fallback generic name: AZITHROMYCIN
AZITHROMYCIN	AZITHROMYCIN	A-S Medication Solutions	76093152-e2d7-4fe1-8568-1f0fec1747c2	2026-07-01	Warnings, Adverse reactions	Name fallback generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	REMEDYREPACK INC.	943b9246-7733-44b1-875c-91d2ade78ac4	2026-06-29	Warnings, Adverse reactions	Name fallback generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	Preferred Pharmaceuticals Inc.	661ff7a6-6394-493d-a307-a1f607e5d117	2026-06-16	Warnings, Adverse reactions	Name fallback generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	Bryant Ranch Prepack	b5d79719-b1dc-469f-a19c-f8ba615138f0	2026-05-14	Warnings, Adverse reactions	Name fallback generic name: AZITHROMYCIN
azithromycin	AZITHROMYCIN	Coupler LLC	510024c9-6658-e08f-e063-6294a90a0793	2026-05-04	Warnings, Adverse reactions	Name fallback generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	Sportpharm LLC	397471e5-76e2-462c-af30-bcc54fe00266	2026-04-24	Warnings, Adverse reactions	Name fallback generic name: AZITHROMYCIN
azithromycin	AZITHROMYCIN	Cardinal Health 107, LLC	ea128124-8712-4998-be46-47d43ef127d4	2026-04-10	Warnings, Adverse reactions	Name fallback generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	Bryant Ranch Prepack	a81212ef-76b6-4bd7-8706-3d2b05ee34f9	2026-03-30	Warnings, Adverse reactions	Name fallback generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	A-S Medication Solutions	24c07398-84ad-48e2-9625-e9073c28fb73	2026-03-24	Warnings, Adverse reactions	Name fallback generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	A-S Medication Solutions	77c5e4c6-6d16-40fe-bf36-cb441348f39b	2026-03-24	Warnings, Adverse reactions	Name fallback generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	AvKARE	dc633b7d-5154-7e43-e053-2a95a90ad2a6	2026-03-17	Warnings, Adverse reactions	Name fallback generic name: AZITHROMYCIN
AZITHROMYCIN	AZITHROMYCIN	DIRECT RX	a5b4092d-ab72-f5d1-e053-2995a90ac582	2026-03-17	Warnings, Adverse reactions	Name fallback generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	Preferred Pharmaceuticals Inc.	003307c5-3f73-4a5d-a704-bfdea3c656e8	2026-03-16	Warnings, Adverse reactions	Name fallback generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	Preferred Pharmaceuticals Inc.	4eec460d-5ba8-4614-8700-219a9b4fc385	2026-03-16	Warnings, Adverse reactions	Name fallback generic name: AZITHROMYCIN
AZITHROMYCIN	AZITHROMYCIN	Preferred Pharmaceuticals, Inc.	9e4fbd52-43e4-4d87-a136-f4d680a8d0c1	2026-03-12	Warnings, Adverse reactions	Name fallback generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	Preferred Pharmaceuticals Inc.	ac327054-21ab-401c-a27a-48259db18f89	2026-03-11	Warnings, Adverse reactions	Name fallback generic name: AZITHROMYCIN

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 25 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0069-3051	ZITHROMAX	AZITHROMYCIN DIHYDRATE	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3051	ZITHROMAX	AZITHROMYCIN DIHYDRATE	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3051	ZITHROMAX	AZITHROMYCIN DIHYDRATE	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3051	ZITHROMAX	AZITHROMYCIN DIHYDRATE	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3051	ZITHROMAX	AZITHROMYCIN DIHYDRATE	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3051	ZITHROMAX	AZITHROMYCIN DIHYDRATE	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3051	ZITHROMAX	AZITHROMYCIN DIHYDRATE	Pfizer Laboratories Div P	NDA	Current
0069-3051	ZITHROMAX	AZITHROMYCIN DIHYDRATE	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3051	ZITHROMAX	AZITHROMYCIN DIHYDRATE	Pfizer Laboratories Div Pfizer Inc	NDA	Current
53002-2225	azithromycin	AZITHROMYCIN	RPK Pharmaceuticals, Inc.	NDA	Current
53002-2225	azithromycin	AZITHROMYCIN	RPK Pharmaceuticals, Inc.	NDA	Current
59762-3051	azithromycin	AZITHROMYCIN	Greenstone LLC	NDA	Current
59762-3051	azithromycin	AZITHROMYCIN	Greenstone LLC	NDA	Current
59762-3051	azithromycin	AZITHROMYCIN	Greenstone LLC	NDA	Current
59762-3051	azithromycin	AZITHROMYCIN	Greenstone LLC	NDA	Current
59762-3051	azithromycin	AZITHROMYCIN	Greenstone LLC	NDA	Current
59762-3051	azithromycin	AZITHROMYCIN	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-3051	azithromycin	AZITHROMYCIN	Greenstone LLC	NDA	Current
59762-3051	azithromycin	AZITHROMYCIN	Greenstone LLC	NDA	Current
59762-3051	azithromycin	AZITHROMYCIN	Greenstone LLC	NDA	Current
68258-3051	azithromycin	azithromycin	Dispensing Solutions, Inc.	NDA	Current
68788-0713	azithromycin	AZITHROMYCIN	Preferred Pharmaceuticals, Inc.	NDA	Current
68788-0713	azithromycin	AZITHROMYCIN	Preferred Pharmaceuticals, Inc.	NDA	Current
68788-0713	azithromycin	AZITHROMYCIN	Preferred Pharmaceuticals, Inc.	NDA	Current
68788-0713	azithromycin	AZITHROMYCIN	Preferred Pharmaceuticals, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
69392	SUPPL	2021-11-23
69375	SUPPL	2021-11-22
58432	SUPPL	2019-04-26
58415	SUPPL	2019-04-25
47838	SUPPL	2017-04-03
47785	SUPPL	2017-03-30
47181	SUPPL	2017-02-13
47182	SUPPL	2017-02-10
39128	SUPPL	2016-05-25
30293	SUPPL	2016-05-25
30291	SUPPL	2014-06-11
39127	SUPPL	2014-06-10
44203	ORIG	2013-03-12
30292	SUPPL	2013-02-21
18033	SUPPL	2013-02-21
39126	SUPPL	2012-11-06
8020	SUPPL	2012-11-06
18032	SUPPL	2012-06-11
8021	SUPPL	2012-06-08
18031	SUPPL	2011-02-04
30290	SUPPL	2011-02-03
39125	SUPPL	2010-08-19
8019	SUPPL	2010-08-17
18030	SUPPL	2009-04-03
30289	SUPPL	2009-03-10
30288	SUPPL	2007-11-08
39124	SUPPL	2007-11-07
18029	SUPPL	2004-04-05
30287	SUPPL	2004-03-28
8018	SUPPL	2004-01-22
8016	SUPPL	2002-10-16
8017	SUPPL	2002-07-22
42681	SUPPL	2000-11-13
39123	SUPPL	2000-11-13
8015	SUPPL	2000-11-13