Application 065218

Type: ANDA
Sponsor: PLIVA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AZITHROMYCIN	AZITHROMYCIN	TABLET;ORAL	EQ 600MG BASE	No	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
A065218-001	AZITHROMYCIN	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	RS	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
A065218-001	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A065218-001	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	RS	2005-11-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065218-001	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	RS	2005-11-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065218-001	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	RS	2005-11-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065218-001	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	RS	2005-11-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065218-001	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	RS	2005-11-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065218-001	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	RS	2005-11-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065218-001	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	RS	2005-11-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065218-001	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	RS	2005-11-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065218-001	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	RS	2005-11-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065218-001	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	RS	2005-11-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065218-001	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	RS	2005-11-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065218-001	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	RS	2005-11-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065218-001	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	RS	2005-11-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065218-001	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	RS	2005-11-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065218-001	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	RS	2005-11-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065218-001	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	RS	2005-11-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065218-001	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	RS	2005-11-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065218-001	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	RS	2005-11-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065218-001	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	RS	2005-11-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065218-001	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	RS	2005-11-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065218-001	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	RS	2005-11-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065218-001	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	RS	2005-11-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065218-001	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	RS	2005-11-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065218-001	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	RS	2005-11-14	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065218-001	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	RS	2005-11-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065218-001	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	RS	2005-11-14	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065218-001	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB		2005-11-14	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065218-001	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	RS	2005-11-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065218-001	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	RS	2005-11-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065218-001	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	RS	2005-11-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065218-001	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	RS	2005-11-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065218-001	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	RS	2005-11-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065218-001	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	RS	2005-11-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065218-001	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	RS	2005-11-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065218-001	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	RS	2005-11-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065218-001	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	RS	2005-11-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065218-001	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	RS	2005-11-14	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065218-001	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	RS	2005-11-14	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065218-001	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	RS	2005-11-14	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A065218-001	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	RS	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	A065218-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065218-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065218-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065218-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065218-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065218-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065218-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065218-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065218-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065218-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065218-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065218-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065218-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065218-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065218-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065218-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065218-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065218-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065218-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065218-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065218-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065218-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065218-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065218-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065218-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065218-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065218-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065218-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065218-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065218-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065218-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065218-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065218-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065218-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065218-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065218-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065218-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065218-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065218-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A065218-001	AB	1	`cb3db0bc1861…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Azithromycin	AZITHROMYCIN	AvKARE	16da30a2-d11c-7e8c-e063-6294a90a62e3	2026-01-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065218 application number: ANDA065218
Azithromycin	AZITHROMYCIN	Teva Pharmaceuticals USA, Inc.	ac549022-4d7f-4c9f-9244-1a2df9a27276	2022-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065218 application number: ANDA065218 ndc (product): 50111-789

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 11 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50111-789	Azithromycin	Azithromycin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
50111-789	Azithromycin	Azithromycin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
50111-789	Azithromycin	Azithromycin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
50111-789	Azithromycin	Azithromycin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
50111-789	Azithromycin	Azithromycin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
70518-0713	Azithromycin	Azithromycin	REMEDYREPACK INC.	ANDA	Current
70518-0713	Azithromycin	Azithromycin	REMEDYREPACK INC.	ANDA	Current
70518-0713	Azithromycin	Azithromycin	REMEDYREPACK INC.	ANDA	Current
70518-0713	Azithromycin	Azithromycin	REMEDYREPACK INC.	ANDA	Current
70518-0713	Azithromycin	Azithromycin	REMEDYREPACK INC.	ANDA	Current
70518-0713	Azithromycin	Azithromycin	REMEDYREPACK INC.	ANDA	Current