Azithromycin

Product NDC: 76420-589
11-digit product format: 764200589
Labeler code: 76420
Product ID: 76420-589_04472220-f8c1-1f1a-e063-6294a90a2bb2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Azithromycin
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Asclemed USA, Inc.
Application: ANDA065223
Marketing category: ANDA
Marketing start: 2006-01-06
Substance: AZITHROMYCIN MONOHYDRATE
Active strength: 500 mg/1
Pharmacologic classes: Macrolide Antimicrobial [EPC], Macrolides [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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

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
A065223-001	AZITHROMYCIN	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB		2005-11-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065223-001	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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A065223-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2005-11-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065223-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2005-11-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065223-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2005-11-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065223-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2005-11-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065223-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2005-11-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065223-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2005-11-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065223-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2005-11-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065223-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2005-11-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065223-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2005-11-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065223-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2005-11-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065223-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2005-11-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065223-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2005-11-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065223-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2005-11-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065223-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2005-11-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065223-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2005-11-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065223-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2005-11-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065223-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2005-11-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065223-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2005-11-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065223-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2005-11-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065223-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2005-11-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065223-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2005-11-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065223-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2005-11-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065223-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2005-11-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065223-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2005-11-14	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065223-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2005-11-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065223-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2005-11-14	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065223-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2005-11-14	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065223-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2005-11-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065223-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2005-11-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065223-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2005-11-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065223-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2005-11-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065223-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2005-11-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065223-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2005-11-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065223-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2005-11-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065223-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2005-11-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065223-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2005-11-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065223-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2005-11-14	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065223-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2005-11-14	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065223-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2005-11-14	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A065223-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2005-11-14	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A065223-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065223-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065223-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065223-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065223-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065223-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065223-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065223-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065223-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065223-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065223-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065223-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065223-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065223-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065223-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065223-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065223-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065223-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065223-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065223-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065223-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065223-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065223-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065223-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065223-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065223-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065223-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065223-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065223-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065223-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065223-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065223-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065223-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065223-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065223-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065223-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065223-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065223-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065223-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A065223-001	AB	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Azithromycin
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
AZITHROMYCIN MONOHYDRATE	500 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
JTE4MNN1MD	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
248656	Internal RxNorm lookup
308460	Internal RxNorm lookup
749780	Internal RxNorm lookup
749783	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
9c44af6d-8a9a-cb4c-e053-2a95a90afdac	Available on FDA.report

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 Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
76420-589-03	Azithromycin	3 in 1 BLISTER PACK	TABLET, FILM COATED	3		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
76420-589-03	EA - Each	76420-589	2c58f4b8-0715-4492-b972-dc786495f1ce	1	2024-09-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76420-589	AZITHROMYCIN TABLET, FILM COATED [ASCLEMED USA, INC.]	3	Current NDC, 1 package rows	20230902_9c44af6d-8a9a-cb4c-e053-2a95a90afdac.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Azithromycin	AZITHROMYCIN	REMEDYREPACK INC.	943b9246-7733-44b1-875c-91d2ade78ac4	2026-06-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065223 application number: ANDA065223
Azithromycin	AZITHROMYCIN	Sportpharm LLC	397471e5-76e2-462c-af30-bcc54fe00266	2026-04-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065223 application number: ANDA065223
Azithromycin	AZITHROMYCIN	Asclemed USA, Inc.	9c44af6d-8a9a-cb4c-e053-2a95a90afdac	2023-09-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065223 application number: ANDA065223 ndc (product): 76420-589
Azithromycin	AZITHROMYCIN	Teva Pharmaceuticals USA, Inc.	f6a52c0b-45db-422e-8c22-e867a11b4439	2023-03-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065223 application number: ANDA065223
Azithromycin	AZITHROMYCIN	Proficient Rx LP	7e7c2f49-449c-4ba2-98ae-0ff0c040614c	2022-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065223 application number: ANDA065223

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
JTE4MNN1MD	AZITHROMYCIN MONOHYDRATE	121470-24-4	AZITHROMYCIN MONOHYDRATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
749780	{3 (azithromycin 500 MG Oral Tablet) } Pack	GPCK	9c44af6d-8a9a-cb4c-e053-2a95a90afdac	3
749783	{6 (azithromycin 250 MG Oral Tablet) } Pack	GPCK	9c44af6d-8a9a-cb4c-e053-2a95a90afdac	3
308460	azithromycin 250 MG Oral Tablet	PSN	9c44af6d-8a9a-cb4c-e053-2a95a90afdac	3
749783	azithromycin 250 MG Oral Tablet 6 Count Pack	PSN	9c44af6d-8a9a-cb4c-e053-2a95a90afdac	3
248656	azithromycin 500 MG Oral Tablet	PSN	9c44af6d-8a9a-cb4c-e053-2a95a90afdac	3
749780	azithromycin 500 MG Oral Tablet 3 Count Pack	PSN	9c44af6d-8a9a-cb4c-e053-2a95a90afdac	3
308460	azithromycin 250 MG Oral Tablet	SCD	9c44af6d-8a9a-cb4c-e053-2a95a90afdac	3
248656	azithromycin 500 MG Oral Tablet	SCD	9c44af6d-8a9a-cb4c-e053-2a95a90afdac	3
749783	azithromycin 250 MG Oral Tablet 6 Count Pack	SY	9c44af6d-8a9a-cb4c-e053-2a95a90afdac	3
248656	azithromycin 500 MG (as azithromycin monohydrate) Oral Tablet	SY	9c44af6d-8a9a-cb4c-e053-2a95a90afdac	3
749780	azithromycin 500 MG Oral Tablet 3 Count Pack	SY	9c44af6d-8a9a-cb4c-e053-2a95a90afdac	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
76420-589-03	76420058903	3 TABLET, FILM COATED in 1 BLISTER PACK (76420-589-03)	2023-09-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Azithromycin	Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	2023-09-01	HUMAN PRESCRIPTION DRUG LABEL	3