Zithromax

Product NDC: 70518-0336
11-digit product format: 705180336
Labeler code: 70518
Product ID: 70518-0336_e7649550-3be7-045e-e053-2995a90a080b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: azithromycin dihydrate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: NDA050784
Marketing category: NDA
Marketing start: 2017-03-20
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: 2023-12-31
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 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	70518-0336		D	Discontinued by firm	2026-08-17
excluded package	package	70518-0336	70518-0336-0	D	Discontinued by firm	2026-08-17
excluded package	package	70518-0336	70518-0336-1	D	Discontinued by firm	2026-08-17
excluded package	package	70518-0336	70518-0336-2	D	Discontinued by firm	2026-08-17
excluded package	package	70518-0336	70518-0336-4	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 · 25 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	70518-0336-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70518-0336-2	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70518-0336-4	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70518-0336-0	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70518-0336-2	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70518-0336-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70518-0336-0	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	70518-0336-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	70518-0336-0	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	70518-0336-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	70518-0336-0	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	70518-0336-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	70518-0336-0	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	70518-0336-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	70518-0336-0	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	70518-0336-1	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	70518-0336-0	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	70518-0336-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	70518-0336-0	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	70518-0336-1	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	70518-0336-0	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	70518-0336-1	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	70518-0336-1	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	70518-0336-1	`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 Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
bc5cb41f-7cc8-4f57-b1a7-5eaf0458a401	Product name	9	20200616
a2cbe82e-b432-4f71-954b-75e9214e8567	Product name	3	20200612
371533fa-efb3-4c48-b5e4-60179db407f3	Product name	3	20190124

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70518-0336-4	EA - Each	70518-0336	f4b6a64f-b6e7-46b6-88ff-f80606eb81ba	1	2026-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70518-0336	ZITHROMAX (AZITHROMYCIN DIHYDRATE) TABLET, FILM COATED [REMEDYREPACK INC.]	24	Legacy NDC	20250426_fbb9b312-0664-4a6f-9111-69a7749311e0.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	Marketing start	Marketing end	Sample	Exclude flag	Status
70518-0336-0	70518033600	2 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-0336-0)	2017-03-20	0000-00-00	No	No	Current
70518-0336-1	70518033601	4 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-0336-1)	2019-10-10	0000-00-00	No	No	Current