Azithromycin

Product NDC: 76420-649
Requested package NDC: 76420-649-06
11-digit product format: 764200649
Labeler code: 76420
Product ID: 76420-649_0dc7bda4-7a99-9041-e063-6294a90a5157
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Azithromycin
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Asclemed USA, Inc.
Application: ANDA210000
Marketing category: ANDA
Marketing start: 2022-04-11
Substance: AZITHROMYCIN DIHYDRATE
Active strength: 250 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 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
A210000-001	AZITHROMYCIN	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB		2019-02-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210000-001	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 · 43 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
2026-09-14 22:38:34	2026-08	A210000-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2019-02-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210000-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2019-02-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210000-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2019-02-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210000-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2019-02-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210000-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2019-02-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210000-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2019-02-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210000-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2019-02-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210000-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2019-02-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210000-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2019-02-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210000-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2019-02-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210000-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2019-02-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210000-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2019-02-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210000-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2019-02-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210000-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2019-02-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210000-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2019-02-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210000-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2019-02-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210000-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2019-02-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210000-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2019-02-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210000-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2019-02-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210000-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2019-02-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210000-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2019-02-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210000-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2019-02-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210000-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2019-02-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210000-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2019-02-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210000-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2019-02-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210000-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2019-02-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210000-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2019-02-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210000-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2019-02-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210000-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2019-02-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210000-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2019-02-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210000-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2019-02-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210000-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2019-02-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210000-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2019-02-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210000-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2019-02-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210000-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2019-02-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210000-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2019-02-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210000-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2019-02-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210000-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2019-02-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210000-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2019-02-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210000-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2019-02-26	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A210000-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210000-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210000-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210000-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210000-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210000-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210000-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210000-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210000-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210000-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210000-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210000-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210000-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210000-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210000-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210000-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210000-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210000-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210000-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210000-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210000-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210000-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210000-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210000-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210000-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210000-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210000-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210000-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210000-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210000-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210000-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210000-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210000-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210000-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210000-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210000-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210000-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210000-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210000-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210000-001	AB	1	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
AZITHROMYCIN DIHYDRATE	250 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
5FD1131I7S	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
308460	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
b77b347d-d357-4bdf-b985-49d9a1dd634c	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
76420-649-06	Azithromycin	6 in 1 BOTTLE	TABLET, FILM COATED	6		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76420-649	AZITHROMYCIN TABLET, FILM COATED [ASCLEMED USA, INC.]	1	Current NDC, 1 package rows	20240103_b77b347d-d357-4bdf-b985-49d9a1dd634c.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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Azithromycin	AZITHROMYCIN	AvKARE	dc633b7d-5154-7e43-e053-2a95a90ad2a6	2026-03-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210000 application number: ANDA210000
AZITHROMYCIN	AZITHROMYCIN	DIRECT RX	a5b4092d-ab72-f5d1-e053-2995a90ac582	2026-03-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210000 application number: ANDA210000
Azithromycin	AZITHROMYCIN	Bionpharma Inc.	859bb02c-a4bc-46fa-9fc9-def1219b5dfb	2025-12-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210000 application number: ANDA210000
Azithromycin	AZITHROMYCIN	NuCare Pharmaceuticals,Inc.	b0138503-ddc4-2e1c-e053-2995a90a0d2d	2024-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210000 application number: ANDA210000
Azithromycin	AZITHROMYCIN	Asclemed USA, Inc.	b77b347d-d357-4bdf-b985-49d9a1dd634c	2023-12-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210000 application number: ANDA210000 ndc (package): 76420-649-06 ndc (product): 76420-649 ndc11 (package): 76420064906
Azithromycin	AZITHROMYCIN	A-S Medication Solutions	af720986-48a9-48b5-bdd7-370f6a2f92e1	2023-04-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210000 application number: ANDA210000
Azithromycin	AZITHROMYCIN	Proficient Rx LP	99ca0089-14a9-446d-8807-253ad5be3efa	2022-09-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210000 application number: ANDA210000
Azithromycin	AZITHROMYCIN	Doc Rx	90ff7cfc-73c9-4d77-83df-c05cfbbbbecd	2021-06-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210000 application number: ANDA210000

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
749783	{6 (azithromycin 250 MG Oral Tablet) } Pack	GPCK	b77b347d-d357-4bdf-b985-49d9a1dd634c	1
308460	azithromycin 250 MG Oral Tablet	PSN	b77b347d-d357-4bdf-b985-49d9a1dd634c	1
749783	azithromycin 250 MG Oral Tablet 6 Count Pack	PSN	b77b347d-d357-4bdf-b985-49d9a1dd634c	1
308460	azithromycin 250 MG Oral Tablet	SCD	b77b347d-d357-4bdf-b985-49d9a1dd634c	1
749783	azithromycin 250 MG Oral Tablet 6 Count Pack	SY	b77b347d-d357-4bdf-b985-49d9a1dd634c	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
76420-649-06	76420064906	6 TABLET, FILM COATED in 1 BOTTLE (76420-649-06)	2023-12-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Azithromycin	Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	2023-12-30	HUMAN PRESCRIPTION DRUG LABEL	1