azithromycin

Product NDC: 59762-3070
11-digit product format: 597623070
Labeler code: 59762
Product ID: 59762-3070_e65a0723-d06f-49f1-8af5-88f67338a90f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: azithromycin
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Greenstone LLC
Application: NDA050784
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2002-05-24
Marketing end: 0000-00-00
Substance: AZITHROMYCIN DIHYDRATE
Active strength: 500 mg/1
Pharmacologic classes: Macrolide Antimicrobial [EPC],Macrolides [CS]
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	59762-3070		D	Discontinued by firm	2026-08-17
excluded package	package	59762-3070	59762-3070-1	D	Discontinued by firm	2026-08-17
excluded package	package	59762-3070	59762-3070-2	D	Discontinued by firm	2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 36 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	59762-3070-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	59762-3070-2	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	59762-3070-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	59762-3070-2	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	59762-3070-2	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	59762-3070-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	59762-3070-2	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	59762-3070-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	59762-3070-2	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	59762-3070-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	59762-3070-2	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	59762-3070-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	59762-3070-2	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	59762-3070-1	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	59762-3070-2	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	59762-3070-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	59762-3070-2	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	59762-3070-1	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	59762-3070-2	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	59762-3070-1	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	59762-3070-2	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	59762-3070-1	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	59762-3070-1	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	59762-3070-2	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N050784-001	ZITHROMAX	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	RLD	2002-05-24

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
N050784-001	AB

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 · 42 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
2026-08-18 06:07:40	2026-07	N050784-001	ZITHROMAX	EQ 500MG BASE	TABLET / ORAL	AB	RLD	2002-05-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N050784-001	ZITHROMAX	EQ 500MG BASE	TABLET / ORAL	AB	RLD	2002-05-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050784-001	ZITHROMAX	EQ 500MG BASE	TABLET / ORAL	AB	RLD	2002-05-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050784-001	ZITHROMAX	EQ 500MG BASE	TABLET / ORAL	AB	RLD	2002-05-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050784-001	ZITHROMAX	EQ 500MG BASE	TABLET / ORAL	AB	RLD	2002-05-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050784-001	ZITHROMAX	EQ 500MG BASE	TABLET / ORAL	AB	RLD	2002-05-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050784-001	ZITHROMAX	EQ 500MG BASE	TABLET / ORAL	AB	RLD	2002-05-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050784-001	ZITHROMAX	EQ 500MG BASE	TABLET / ORAL	AB	RLD	2002-05-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050784-001	ZITHROMAX	EQ 500MG BASE	TABLET / ORAL	AB	RLD	2002-05-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050784-001	ZITHROMAX	EQ 500MG BASE	TABLET / ORAL	AB	RLD	2002-05-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050784-001	ZITHROMAX	EQ 500MG BASE	TABLET / ORAL	AB	RLD	2002-05-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050784-001	ZITHROMAX	EQ 500MG BASE	TABLET / ORAL	AB	RLD	2002-05-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050784-001	ZITHROMAX	EQ 500MG BASE	TABLET / ORAL	AB	RLD	2002-05-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050784-001	ZITHROMAX	EQ 500MG BASE	TABLET / ORAL	AB	RLD	2002-05-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050784-001	ZITHROMAX	EQ 500MG BASE	TABLET / ORAL	AB	RLD	2002-05-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050784-001	ZITHROMAX	EQ 500MG BASE	TABLET / ORAL	AB	RLD	2002-05-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050784-001	ZITHROMAX	EQ 500MG BASE	TABLET / ORAL	AB	RLD	2002-05-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050784-001	ZITHROMAX	EQ 500MG BASE	TABLET / ORAL	AB	RLD	2002-05-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050784-001	ZITHROMAX	EQ 500MG BASE	TABLET / ORAL	AB	RLD	2002-05-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050784-001	ZITHROMAX	EQ 500MG BASE	TABLET / ORAL	AB	RLD	2002-05-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050784-001	ZITHROMAX	EQ 500MG BASE	TABLET / ORAL	AB	RLD	2002-05-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050784-001	ZITHROMAX	EQ 500MG BASE	TABLET / ORAL	AB	RLD	2002-05-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050784-001	ZITHROMAX	EQ 500MG BASE	TABLET / ORAL	AB	RLD	2002-05-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050784-001	ZITHROMAX	EQ 500MG BASE	TABLET / ORAL	AB	RLD	2002-05-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050784-001	ZITHROMAX	EQ 500MG BASE	TABLET / ORAL	AB	RLD	2002-05-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050784-001	ZITHROMAX	EQ 500MG BASE	TABLET / ORAL	AB	RLD	2002-05-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050784-001	ZITHROMAX	EQ 500MG BASE	TABLET / ORAL	AB	RLD	2002-05-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050784-001	ZITHROMAX	EQ 500MG BASE	TABLET / ORAL	AB	RLD	2002-05-24	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050784-001	ZITHROMAX	EQ 500MG BASE	TABLET / ORAL	AB	RLD	2002-05-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N050784-001	ZITHROMAX	EQ 500MG BASE	TABLET / ORAL	AB	RLD	2002-05-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N050784-001	ZITHROMAX	EQ 500MG BASE	TABLET / ORAL	AB	RLD	2002-05-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050784-001	ZITHROMAX	EQ 500MG BASE	TABLET / ORAL	AB	RLD	2002-05-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050784-001	ZITHROMAX	EQ 500MG BASE	TABLET / ORAL	AB	RLD	2002-05-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050784-001	ZITHROMAX	EQ 500MG BASE	TABLET / ORAL	AB	RLD	2002-05-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050784-001	ZITHROMAX	EQ 500MG BASE	TABLET / ORAL	AB	RLD	2002-05-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N050784-001	ZITHROMAX	EQ 500MG BASE	TABLET / ORAL	AB	RLD	2002-05-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N050784-001	ZITHROMAX	EQ 500MG BASE	TABLET / ORAL	AB	RLD	2002-05-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050784-001	ZITHROMAX	EQ 500MG BASE	TABLET / ORAL	AB	RLD	2002-05-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N050784-001	ZITHROMAX	EQ 500MG BASE	TABLET / ORAL	AB	RLD	2002-05-24	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N050784-001	ZITHROMAX	EQ 500MG BASE	TABLET / ORAL	AB	RLD	2002-05-24	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N050784-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N050784-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050784-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050784-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050784-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050784-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050784-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050784-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050784-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050784-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050784-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050784-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050784-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050784-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050784-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050784-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050784-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050784-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050784-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050784-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050784-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050784-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050784-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050784-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050784-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050784-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050784-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050784-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050784-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N050784-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N050784-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050784-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050784-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050784-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050784-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N050784-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N050784-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050784-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N050784-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N050784-001	AB	1	`e64feba35796…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59762-3070-1	EA - Each	59762-3070	bcd4a896-0cfb-412e-b9c2-405b1aec0a14	1	2012-07-24
59762-3070-2	EA - Each	59762-3070	0dac1135-cf57-49a3-b271-8fef9cd37c49	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
AZITHROMYCIN DIHYDRATE	ACTIVE INGREDIENT	5FD1131I7S	AZITHROMYCIN TABLET, FILM COATED AZITHROMYCIN POWDER, FOR SUSPENSION [GREENSTONE LLC]	15
AZITHROMYCIN ANHYDROUS	ACTIVE MOIETY	J2KLZ20U1M	AZITHROMYCIN TABLET, FILM COATED AZITHROMYCIN POWDER, FOR SUSPENSION [GREENSTONE LLC]	15
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	AZITHROMYCIN TABLET, FILM COATED AZITHROMYCIN POWDER, FOR SUSPENSION [GREENSTONE LLC]	15
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	INACTIVE INGREDIENT	L11K75P92J	AZITHROMYCIN TABLET, FILM COATED AZITHROMYCIN POWDER, FOR SUSPENSION [GREENSTONE LLC]	15
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	AZITHROMYCIN TABLET, FILM COATED AZITHROMYCIN POWDER, FOR SUSPENSION [GREENSTONE LLC]	15
D&C RED NO. 30	INACTIVE INGREDIENT	2S42T2808B	AZITHROMYCIN TABLET, FILM COATED AZITHROMYCIN POWDER, FOR SUSPENSION [GREENSTONE LLC]	15
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	AZITHROMYCIN TABLET, FILM COATED AZITHROMYCIN POWDER, FOR SUSPENSION [GREENSTONE LLC]	15
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	AZITHROMYCIN TABLET, FILM COATED AZITHROMYCIN POWDER, FOR SUSPENSION [GREENSTONE LLC]	15
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	AZITHROMYCIN TABLET, FILM COATED AZITHROMYCIN POWDER, FOR SUSPENSION [GREENSTONE LLC]	15
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	AZITHROMYCIN TABLET, FILM COATED AZITHROMYCIN POWDER, FOR SUSPENSION [GREENSTONE LLC]	15
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	AZITHROMYCIN TABLET, FILM COATED AZITHROMYCIN POWDER, FOR SUSPENSION [GREENSTONE LLC]	15
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	AZITHROMYCIN TABLET, FILM COATED AZITHROMYCIN POWDER, FOR SUSPENSION [GREENSTONE LLC]	15
SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS	INACTIVE INGREDIENT	SX01TZO3QZ	AZITHROMYCIN TABLET, FILM COATED AZITHROMYCIN POWDER, FOR SUSPENSION [GREENSTONE LLC]	15
SUCROSE	INACTIVE INGREDIENT	C151H8M554	AZITHROMYCIN TABLET, FILM COATED AZITHROMYCIN POWDER, FOR SUSPENSION [GREENSTONE LLC]	15
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	AZITHROMYCIN TABLET, FILM COATED AZITHROMYCIN POWDER, FOR SUSPENSION [GREENSTONE LLC]	15
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	AZITHROMYCIN TABLET, FILM COATED AZITHROMYCIN POWDER, FOR SUSPENSION [GREENSTONE LLC]	15
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	AZITHROMYCIN TABLET, FILM COATED AZITHROMYCIN POWDER, FOR SUSPENSION [GREENSTONE LLC]	15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59762-3070	AZITHROMYCIN TABLET, FILM COATED AZITHROMYCIN POWDER, FOR SUSPENSION [GREENSTONE LLC]	41	Legacy NDC	20250416_f5b6daad-b5a9-462d-8e10-db22a7af1c72.zip

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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Zithromax	AZITHROMYCIN DIHYDRATE	Pfizer Laboratories Div Pfizer Inc	db52b91e-79f7-4cc1-9564-f2eee8e31c45	2026-07-24	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050784 application number: NDA050784

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
5FD1131I7S	AZITHROMYCIN DIHYDRATE	117772-70-0	AZITHROMYCIN DIHYDRATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
59762-3070-1	59762307001	3 BLISTER PACK in 1 BOX (59762-3070-1) > 3 TABLET, FILM COATED in 1 BLISTER PACK	3 blister pack	2002-05-24	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
azithromycin	Mylan Pharmaceuticals Inc. \| Pfizer Inc \| Viatris Pharmaceuticals LLC \| Pfizer Asia Manufacturing Pte Ltd \| Pfizer Ireland Pharmaceuticals Unlimited Company \| Pfizer Manufacturing Deutschland GmbH	2025-06-05	HUMAN PRESCRIPTION DRUG LABEL	42
azithromycin	Bryant Ranch Prepack	2020-10-16	HUMAN PRESCRIPTION DRUG LABEL	3