Application 065211

Type: ANDA
Sponsor: SANDOZ

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AZITHROMYCIN	AZITHROMYCIN	TABLET;ORAL	EQ 250MG BASE	No	No

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
A065211-001	AZITHROMYCIN	AZITHROMYCIN	EQ 250MG 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
A065211-001	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	A065211-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2005-11-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065211-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2005-11-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065211-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2005-11-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065211-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2005-11-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065211-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2005-11-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065211-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2005-11-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065211-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2005-11-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065211-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2005-11-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065211-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2005-11-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065211-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2005-11-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065211-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2005-11-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065211-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2005-11-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065211-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2005-11-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065211-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2005-11-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065211-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2005-11-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065211-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2005-11-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065211-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2005-11-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065211-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2005-11-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065211-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2005-11-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065211-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2005-11-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065211-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2005-11-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065211-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2005-11-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065211-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2005-11-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065211-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2005-11-14	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065211-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2005-11-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065211-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2005-11-14	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065211-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2005-11-14	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065211-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2005-11-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065211-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2005-11-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065211-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2005-11-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065211-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2005-11-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065211-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2005-11-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065211-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2005-11-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065211-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2005-11-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065211-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2005-11-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065211-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2005-11-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065211-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2005-11-14	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065211-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2005-11-14	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065211-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2005-11-14	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A065211-001	AZITHROMYCIN	EQ 250MG 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	A065211-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065211-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065211-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065211-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065211-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065211-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065211-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065211-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065211-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065211-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065211-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065211-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065211-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065211-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065211-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065211-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065211-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065211-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065211-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065211-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065211-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065211-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065211-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065211-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065211-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065211-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065211-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065211-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065211-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065211-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065211-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065211-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065211-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065211-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065211-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065211-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065211-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065211-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065211-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A065211-001	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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Azithromycin	AZITHROMYCIN	Preferred Pharmaceuticals Inc.	661ff7a6-6394-493d-a307-a1f607e5d117	2026-06-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065211 application number: ANDA065211 ndc (product): 68788-8124
Azithromycin	AZITHROMYCIN	Sportpharm LLC	60ec2020-148b-4a2a-96f2-dd09c590ecbb	2026-02-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065211 application number: ANDA065211
Azithromycin	AZITHROMYCIN	Asclemed USA, Inc.	22a4d2b3-daea-4d96-891f-4b9823629456	2024-10-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065211 application number: ANDA065211 ndc (product): 76420-213
Azithromycin	AZITHROMYCIN	Proficient Rx LP	38942011-f86b-4e42-a4ca-05a70d9dd3d9	2024-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065211 application number: ANDA065211 ndc (product): 71205-645
Azithromycin	AZITHROMYCIN	Sandoz Inc	ec619299-e0ef-44dd-acdb-8c53bbfc5b8a	2022-01-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065211 application number: ANDA065211 ndc (product): 0781-8089

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 41 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0781-1496	Azithromycin	Azithromycin	Sandoz Inc	ANDA	Current
0781-5776	Azithromycin	Azithromycin	Sandoz Inc	ANDA	Current
0781-5776	Azithromycin	Azithromycin	Sandoz Inc	ANDA	Current
0781-5776	Azithromycin	Azithromycin	Sandoz Inc	ANDA	Current
0781-5776	Azithromycin	Azithromycin	Sandoz Inc	ANDA	Current
0781-8089	Azithromycin	Azithromycin	Sandoz Inc	ANDA	Current
0781-8089	Azithromycin	Azithromycin	Sandoz Inc	ANDA	Current
0781-8089	Azithromycin	Azithromycin	Sandoz Inc	ANDA	Current
0781-8089	Azithromycin	Azithromycin	Sandoz Inc	ANDA	Current
43353-693	Azithromycin	Azithromycin	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
50090-0959	Azithromycin	Azithromycin	A-S Medication Solutions	ANDA	Current
50436-1496	Azithromycin	Azithromycin	Unit Dose Services	ANDA	Current
53217-173	Azithromycin	Azithromycin	Aidarex Pharmaceuticals LLC	ANDA	Current
54348-854	Azithromycin	AZITHROMYCIN ANHYDROUS	PharmPak, Inc.	ANDA	Current
55154-3432	Azithromycin	Azithromycin	Cardinal Health	ANDA	Current
55700-705	Azithromycin	Azithromycin	Quality Care Products, LLC	ANDA	Current
55700-705	Azithromycin	Azithromycin	Quality Care Products, LLC	ANDA	Current
55700-785	Azithromycin	Azithromycin	Quality Care Products, LLC	ANDA	Current
60760-808	Azithromycin	Azithromycin	St. Mary's Medical Park Pharmacy	ANDA	Current
63187-169	Azithromycin	Azithromycin	Proficient Rx LP	ANDA	Current
63187-169	Azithromycin	Azithromycin	Proficient Rx LP	ANDA	Current
63629-7910	Azithromycin	Azithromycin	Bryant Ranch Prepack	ANDA	Current
63629-7910	Azithromycin	Azithromycin	Bryant Ranch Prepack	ANDA	Current
63739-575	Azithromycin	Azithromycin	McKesson Corporation	ANDA	Current
68788-7066	Azithromycin	Azithromycin	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7066	Azithromycin	Azithromycin	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7066	Azithromycin	Azithromycin	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-8124	Azithromycin	Azithromycin	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-8939	Azithromycin	Azithromycin	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-8939	Azithromycin	Azithromycin	Preferred Pharmaceuticals Inc.	ANDA	Current
70518-0108	Azithromycin	Azithromycin	REMEDYREPACK INC.	ANDA	Current
70518-0193	Azithromycin	Azithromycin	REMEDYREPACK INC.	ANDA	Current
70518-0712	Azithromycin	Azithromycin	REMEDYREPACK INC.	ANDA	Current
70518-0712	Azithromycin	Azithromycin	REMEDYREPACK INC.	ANDA	Current
70518-3217	Azithromycin	Azithromycin	REMEDYREPACK INC.	ANDA	Current
71205-021	Azithromycin	Azithromycin	Proficient Rx LP	ANDA	Current
71205-021	Azithromycin	Azithromycin	Proficient Rx LP	ANDA	Current
71205-645	Azithromycin	Azithromycin	Proficient Rx LP	ANDA	Current
71205-645	Azithromycin	Azithromycin	Proficient Rx LP	ANDA	Current
71610-001	Azithromycin	Azithromycin	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
76420-213	Azithromycin	Azithromycin	Asclemed USA, Inc.	ANDA	Current