azithromycin dihydrate

Product NDC: 80425-0412
11-digit product format: 804250412
Labeler code: 80425
Product ID: 80425-0412_1d0e96cf-245e-cfb7-e063-6294a90a4ced
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: azithromycin dihydrate
Dosage form: TABLET
Route: ORAL
Labeler: Advanced Rx of Tennessee, LLC
Application: ANDA065399
Marketing category: ANDA
Marketing start: 2024-07-10
Substance: AZITHROMYCIN DIHYDRATE
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 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
A065399-001	AZITHROMYCIN	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB		2015-05-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065399-001	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	A065399-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2015-05-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A065399-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2015-05-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065399-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2015-05-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065399-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2015-05-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065399-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2015-05-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065399-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2015-05-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065399-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2015-05-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065399-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2015-05-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065399-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2015-05-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065399-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2015-05-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065399-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2015-05-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065399-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2015-05-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065399-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2015-05-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065399-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2015-05-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065399-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2015-05-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065399-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2015-05-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065399-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2015-05-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065399-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2015-05-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065399-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2015-05-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065399-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2015-05-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065399-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2015-05-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065399-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2015-05-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065399-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2015-05-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065399-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2015-05-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065399-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2015-05-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065399-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2015-05-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065399-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2015-05-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065399-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2015-05-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065399-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2015-05-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065399-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2015-05-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065399-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2015-05-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065399-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2015-05-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065399-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2015-05-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065399-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2015-05-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065399-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2015-05-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065399-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2015-05-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065399-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2015-05-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065399-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2015-05-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065399-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2015-05-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065399-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2015-05-15	`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	A065399-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A065399-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065399-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065399-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065399-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065399-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065399-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065399-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065399-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065399-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065399-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065399-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065399-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065399-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065399-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065399-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065399-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065399-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065399-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065399-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065399-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065399-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065399-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065399-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065399-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065399-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065399-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065399-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065399-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065399-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065399-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065399-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065399-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065399-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065399-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065399-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065399-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065399-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065399-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065399-001	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 dihydrate
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
AZITHROMYCIN DIHYDRATE	500 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
248656	Internal RxNorm lookup
749780	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
1cec44fa-9597-3e58-e063-6394a90ae326	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
80425-0412-1	azithromycin dihydrate	3 in 1 BLISTER PACK	TABLET	3		2
80425-0412-1	azithromycin dihydrate	1 in 1 CARTON	TABLET	1		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
80425-0412-1	EA - Each	80425-0412	ddf873d0-e5b7-4047-97ad-6476186635a7	1	2024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
80425-0412	AZITHROMYCIN DIHYDRATE TABLET [ADVANCED RX OF TENNESSEE, LLC]	2	Current NDC, 2 package rows	20240716_1cec44fa-9597-3e58-e063-6394a90ae326.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	Major Pharmaceuticals	814abe38-da4a-48af-bf4b-2ce04a5aabd1	2026-09-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065399 application number: ANDA065399
azithromycin	AZITHROMYCIN	REMEDYREPACK INC.	bf061799-cdef-40f8-b1ce-bc5eb609f8c3	2026-09-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065399 application number: ANDA065399
azithromycin	AZITHROMYCIN	Lupin Pharmaceuticals, Inc.	01649d79-4677-4577-a3e4-e054f3f9fc3b	2026-08-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065399 application number: ANDA065399
Azithromycin	AZITHROMYCIN	American Health Packaging	6169e56c-10fb-448d-ab0f-14e54fcf2817	2025-06-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065399 application number: ANDA065399
azithromycin dihydrate	AZITHROMYCIN DIHYDRATE	Advanced Rx of Tennessee, LLC	1cec44fa-9597-3e58-e063-6394a90ae326	2024-07-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065399 application number: ANDA065399 ndc (product): 80425-0412

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
749780	{3 (azithromycin 500 MG Oral Tablet) } Pack	GPCK	1cec44fa-9597-3e58-e063-6394a90ae326	2
248656	azithromycin 500 MG Oral Tablet	PSN	1cec44fa-9597-3e58-e063-6394a90ae326	2
749780	azithromycin 500 MG Oral Tablet 3 Count Pack	PSN	1cec44fa-9597-3e58-e063-6394a90ae326	2
248656	azithromycin 500 MG Oral Tablet	SCD	1cec44fa-9597-3e58-e063-6394a90ae326	2
248656	azithromycin 500 MG (as azithromycin monohydrate) Oral Tablet	SY	1cec44fa-9597-3e58-e063-6394a90ae326	2
749780	azithromycin 500 MG Oral Tablet 3 Count Pack	SY	1cec44fa-9597-3e58-e063-6394a90ae326	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
80425-0412-1	80425041201	1 BLISTER PACK in 1 CARTON (80425-0412-1) / 3 TABLET in 1 BLISTER PACK	1 blister pack	2024-07-10	No	No	Current