azithromycin

Product NDC: 50090-2509
Requested package NDC: 50090-2509-0
11-digit product format: 500902509
Labeler code: 50090
Product ID: 50090-2509_35d071e2-33a3-49a2-85da-9839f1dc123f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: azithromycin
Dosage form: POWDER, FOR SUSPENSION
Route: ORAL
Labeler: A-S Medication Solutions
Application: NDA050710
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 1995-10-19
Marketing end: 0000-00-00
Substance: AZITHROMYCIN DIHYDRATE
Active strength: 1200 mg/30mL
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	50090-2509	50090-2509-0	I	Inactivated by FDA		2026-08-11

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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N050710-001	ZITHROMAX	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	1995-10-19
N050710-002	ZITHROMAX	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	1995-10-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N050710-001	AB
N050710-002	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 3 · 82 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
2026-02-19 14:30 UTC	2026-02	N050710-001	ZITHROMAX	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	1995-10-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050710-002	ZITHROMAX	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	1995-10-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050710-001	ZITHROMAX	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	1995-10-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050710-002	ZITHROMAX	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	1995-10-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050710-001	ZITHROMAX	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	1995-10-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050710-002	ZITHROMAX	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	1995-10-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050710-001	ZITHROMAX	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	1995-10-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050710-002	ZITHROMAX	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	1995-10-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050710-001	ZITHROMAX	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	1995-10-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050710-002	ZITHROMAX	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	1995-10-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050710-001	ZITHROMAX	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	1995-10-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050710-002	ZITHROMAX	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	1995-10-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050710-001	ZITHROMAX	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	1995-10-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050710-002	ZITHROMAX	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	1995-10-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050710-001	ZITHROMAX	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	1995-10-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050710-002	ZITHROMAX	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	1995-10-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050710-001	ZITHROMAX	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	1995-10-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050710-002	ZITHROMAX	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	1995-10-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050710-001	ZITHROMAX	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	1995-10-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050710-002	ZITHROMAX	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	1995-10-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050710-001	ZITHROMAX	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	1995-10-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050710-002	ZITHROMAX	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	1995-10-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050710-001	ZITHROMAX	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	1995-10-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050710-002	ZITHROMAX	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	1995-10-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050710-001	ZITHROMAX	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	1995-10-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050710-002	ZITHROMAX	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	1995-10-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050710-001	ZITHROMAX	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	1995-10-19	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N050710-002	ZITHROMAX	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	1995-10-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050710-001	ZITHROMAX	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	1995-10-19	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050710-002	ZITHROMAX	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	1995-10-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050710-001	ZITHROMAX	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	1995-10-19	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N050710-002	ZITHROMAX	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	1995-10-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050710-001	ZITHROMAX	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	1995-10-19	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N050710-002	ZITHROMAX	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	1995-10-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050710-001	ZITHROMAX	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	1995-10-19	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N050710-002	ZITHROMAX	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	1995-10-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050710-001	ZITHROMAX	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	1995-10-19	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N050710-002	ZITHROMAX	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	1995-10-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050710-001	ZITHROMAX	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	1995-10-19	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N050710-002	ZITHROMAX	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	1995-10-19	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N050710-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050710-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050710-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050710-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050710-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050710-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050710-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050710-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050710-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050710-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050710-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050710-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050710-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050710-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050710-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050710-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050710-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050710-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050710-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050710-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050710-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050710-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050710-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050710-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050710-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050710-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050710-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N050710-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050710-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050710-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050710-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N050710-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050710-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N050710-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050710-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N050710-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050710-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N050710-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050710-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N050710-002	AB	1	`782e0a99824c…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50090-2509-0	2024-01-30	C162847	48780-1	1030e365-4795-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use AZITHROMYCIN safely and effectively. See full prescribing information for AZITHROMYCIN. AZITHROMYCIN 250 mg and 500 mg tablets, for oral use AZITHROMYCIN for oral suspension Initial U.S. Approval: 1991

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-2509-0	azithromycin	1 in 1 CARTON	POWDER, FOR SUSPENSION	1		12
50090-2509-0	azithromycin	30 mL in 1 BOTTLE	POWDER, FOR SUSPENSION	30		12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-2509-0	ML - Milliliter	50090-2509	75fc7b56-da80-431f-83b2-541bca9d7871	1	2019-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-2509	AZITHROMYCIN POWDER, FOR SUSPENSION [A-S MEDICATION SOLUTIONS]	12	Legacy NDC, 2 package rows	20220518_e297fd4b-e0f7-4257-9827-729f936e2ba9.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): 050710 application number: NDA050710

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
141963	azithromycin 200 MG in 5 mL Oral Suspension	PSN	e297fd4b-e0f7-4257-9827-729f936e2ba9	12
141963	azithromycin 40 MG/ML Oral Suspension	SCD	e297fd4b-e0f7-4257-9827-729f936e2ba9	12
141963	azithromycin 1200 MG per 30 ML Oral Suspension	SY	e297fd4b-e0f7-4257-9827-729f936e2ba9	12
141963	azithromycin 200 MG per 5 ML Oral Suspension	SY	e297fd4b-e0f7-4257-9827-729f936e2ba9	12
141963	azithromycin 600 MG per 15 ML Oral Suspension	SY	e297fd4b-e0f7-4257-9827-729f936e2ba9	12

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-2509-0	50090250900	1 BOTTLE in 1 CARTON (50090-2509-0) > 30 mL in 1 BOTTLE	1 bottle	2016-10-14	0000-00-00	No	No	Current