Application 065170

Type: ANDA
Sponsor: TARO

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MUPIROCIN	MUPIROCIN	OINTMENT;TOPICAL	2%	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A065170-001	MUPIROCIN	MUPIROCIN	2%	OINTMENT / TOPICAL	AB		2005-09-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065170-001	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 · 42 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
2026-08-18 06:07:40	2026-07	A065170-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2005-09-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065170-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2005-09-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065170-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2005-09-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065170-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2005-09-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065170-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2005-09-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065170-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2005-09-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065170-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2005-09-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065170-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2005-09-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065170-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2005-09-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065170-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2005-09-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065170-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2005-09-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065170-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2005-09-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065170-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2005-09-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065170-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2005-09-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065170-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2005-09-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065170-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2005-09-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065170-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2005-09-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065170-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2005-09-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065170-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2005-09-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065170-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2005-09-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065170-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2005-09-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065170-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2005-09-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065170-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2005-09-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065170-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2005-09-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065170-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2005-09-23	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065170-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2005-09-23	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065170-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2005-09-23	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065170-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2005-09-23	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065170-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2005-09-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065170-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2005-09-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065170-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2005-09-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065170-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2005-09-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065170-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2005-09-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065170-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2005-09-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065170-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2005-09-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065170-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2005-09-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065170-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2005-09-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065170-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2005-09-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065170-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2005-09-23	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065170-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2005-09-23	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A065170-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065170-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065170-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065170-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065170-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065170-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065170-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065170-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065170-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065170-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065170-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065170-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065170-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065170-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065170-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065170-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065170-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065170-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065170-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065170-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065170-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065170-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065170-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065170-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065170-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065170-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065170-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065170-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065170-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065170-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065170-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065170-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065170-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065170-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065170-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065170-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065170-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065170-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065170-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065170-001	AB	1	`e64feba35796…`

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
Mupirocin	MUPIROCIN	Sportpharm LLC	c70dd5d7-6995-4a3d-b19c-9b4a2cfe3da9	2026-05-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065170 application number: ANDA065170
Mupirocin	MUPIROCIN	PAI Holdings, LLC dba PAI Pharma	a822d44d-c651-406c-a2b9-aa8fbe8f89ce	2026-03-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065170 application number: ANDA065170
Mupirocin	MUPIROCIN	AvPAK	8b10c706-ae9c-fc76-e053-2a95a90a4c73	2026-01-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065170 application number: ANDA065170 ndc (product): 50268-568
Mupirocin	MUPIROCIN	Sun Pharmaceutical Industries, Inc.	900bb675-2f03-47e3-854e-257ec4831332	2025-07-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065170 application number: ANDA065170 ndc (product): 51672-1312
Mupirocin	MUPIROCIN	Lohxa	6d59e35c-b262-7940-e053-2991aa0a8908	2025-03-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065170 application number: ANDA065170 ndc (product): 70166-355
Mupirocin	MUPIROCIN	Advanced Rx Pharmacy of Tennessee, LLC	f1a01044-8f2e-4e91-e053-2995a90af722	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065170 application number: ANDA065170 ndc (product): 80425-0254
Mupirocin	MUPIROCIN	NuCare Pharmaceuticals,Inc.	66db1071-024f-aa19-e053-2a91aa0a8e39	2024-06-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065170 application number: ANDA065170 ndc (product): 68071-4321
Mupirocin	MUPIROCIN	Proficient Rx LP	d8766748-6b53-4673-a3ee-5cd8a4301647	2023-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065170 application number: ANDA065170 ndc (product): 63187-151

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 28 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50268-568	Mupirocin	Mupirocin	AvPAK	ANDA	Current
50268-568	Mupirocin	Mupirocin	AvPAK	ANDA	Current
50268-568	Mupirocin	Mupirocin	AvPAK	ANDA	Current
51672-1312	Mupirocin	Mupirocin	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
51672-1312	Mupirocin	Mupirocin	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
53002-9851	Mupirocin	Mupirocin	RPK Pharmaceuticals, Inc.	ANDA	Current
53002-9851	Mupirocin	Mupirocin	RPK Pharmaceuticals, Inc.	ANDA	Current
55700-069	Mupirocin	Mupirocin	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-069	Mupirocin	Mupirocin	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
63187-151	Mupirocin	Mupirocin	Proficient Rx LP	ANDA	Current
63187-151	Mupirocin	Mupirocin	Proficient Rx LP	ANDA	Current
63187-151	Mupirocin	Mupirocin	Proficient Rx LP	ANDA	Current
68071-4321	Mupirocin	Mupirocin	NuCare Pharmaceuticals,In	ANDA	Current
68071-4321	Mupirocin	Mupirocin	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4321	Mupirocin	Mupirocin	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-7993	Mupirocin	Mupirocin	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7993	Mupirocin	Mupirocin	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-9152	Mupirocin	Mupirocin	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9152	Mupirocin	Mupirocin	Preferred Pharmaceuticals, Inc.	ANDA	Current
70166-017	Mupirocin	Mupirocin	Lohxa	ANDA	Current
70166-355	Mupirocin	Mupirocin	Lohxa	ANDA	Current
70166-355	Mupirocin	Mupirocin	Lohxa	ANDA	Current
70518-2344	Mupirocin	Mupirocin	REMEDYREPACK INC.	ANDA	Current
70518-2344	Mupirocin	Mupirocin	REMEDYREPACK INC.	ANDA	Current
70518-2344	Mupirocin	Mupirocin	REMEDYREPACK INC.	ANDA	Current
70518-2344	Mupirocin	Mupirocin	REMEDYREPACK INC.	ANDA	Current
70518-2344	Mupirocin	Mupirocin	REMEDYREPACK INC.	ANDA	Current
80425-0254	Mupirocin	Mupirocin	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current