Application 090480

Type: ANDA
Sponsor: GLENMARK PHARMS

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
A090480-001	MUPIROCIN	MUPIROCIN	2%	OINTMENT / TOPICAL	AB		2011-06-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090480-001	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	A090480-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2011-06-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090480-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2011-06-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090480-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2011-06-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090480-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2011-06-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090480-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2011-06-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090480-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2011-06-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090480-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2011-06-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090480-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2011-06-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090480-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2011-06-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090480-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2011-06-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090480-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2011-06-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090480-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2011-06-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090480-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2011-06-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090480-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2011-06-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090480-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2011-06-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090480-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2011-06-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090480-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2011-06-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090480-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2011-06-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090480-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2011-06-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090480-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2011-06-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090480-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2011-06-08	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090480-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2011-06-08	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090480-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2011-06-08	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090480-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2011-06-08	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090480-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2011-06-08	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090480-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2011-06-08	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090480-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2011-06-08	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090480-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2011-06-08	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090480-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2011-06-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090480-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2011-06-08	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090480-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2011-06-08	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090480-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2011-06-08	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090480-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2011-06-08	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090480-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2011-06-08	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090480-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2011-06-08	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090480-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2011-06-08	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090480-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2011-06-08	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090480-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2011-06-08	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090480-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2011-06-08	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090480-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2011-06-08	`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	A090480-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090480-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090480-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090480-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090480-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090480-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090480-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090480-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090480-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090480-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090480-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090480-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090480-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090480-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090480-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090480-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090480-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090480-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090480-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090480-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090480-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090480-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090480-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090480-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090480-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090480-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090480-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090480-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090480-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090480-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090480-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090480-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090480-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090480-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090480-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090480-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090480-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090480-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090480-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090480-001	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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mupirocin	MUPIROCIN	Preferred Pharmaceuticals Inc.	06a4ee22-d8f8-4a8a-8666-82b14f2d8476	2026-07-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090480 application number: ANDA090480
Mupirocin	MUPIROCIN	Glenmark Pharmaceuticals Inc., USA	ff7428fb-9ce9-4743-b58c-01a05424a57a	2025-10-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090480 application number: ANDA090480 ndc (product): 68462-180
Mupirocin	MUPIROCIN OINTMENT	Kesin Pharma Corporation	b8e115ce-c8ff-4d08-b865-71dc4d0e51a1	2025-05-28	Warnings, Adverse reactions	Exact identifier ndc (product): 81033-020
Mupirocin	MUPIROCIN	NuCare Pharmaceuticals,Inc.	5abf8c5c-e9c9-3b59-e053-2a91aa0ae394	2025-01-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090480 application number: ANDA090480 ndc (product): 68071-4111
Mupirocin	MUPIROCIN	Proficient Rx LP	2777e4f2-2b8d-41f5-a96a-02dec8c7c3e0	2023-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090480 application number: ANDA090480 ndc (product): 63187-015

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 23 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-0898	Mupirocin	Mupirocin	A-S Medication Solutions	ANDA	Current
50436-0180	Mupirocin	Mupirocin	Unit Dose Services	ANDA	Current
53002-9850	Mupirocin	Mupirocin	RPK Pharmaceuticals, Inc.	ANDA	Current
53002-9850	Mupirocin	Mupirocin	RPK Pharmaceuticals, Inc.	ANDA	Current
61919-407	MUPIROCIN	MUPIROCIN	DirectRX	ANDA	Current
63187-015	Mupirocin	Mupirocin	Proficient Rx LP	ANDA	Current
63187-015	Mupirocin	Mupirocin	Proficient Rx LP	ANDA	Current
68071-4111	Mupirocin	Mupirocin	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4111	Mupirocin	Mupirocin	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4111	Mupirocin	Mupirocin	NuCare Pharmaceuticals,Inc.	ANDA	Current
68462-180	Mupirocin	Mupirocin	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-180	Mupirocin	Mupirocin	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-180	Mupirocin	Mupirocin	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-180	Mupirocin	Mupirocin	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68788-8941	Mupirocin	Mupirocin	Preferred Pharmaceuticals, Inc.	ANDA	Current
70518-0292	Mupirocin	Mupirocin	REMEDYREPACK INC.	ANDA	Current
70518-0292	Mupirocin	Mupirocin	REMEDYREPACK INC.	ANDA	Current
70859-001	NuSurgePak Surgical Prep/CarePak	chlorhexidine gluconate, mupirocin, dimethicone	Nucare Pharmaceuticals Inc	ANDA	Current
70859-001	NuSurgePak Surgical Prep/CarePak	chlorhexidine gluconate, mupirocin, dimethicone	Nucare Pharmaceuticals Inc	ANDA	Current
70859-057	NuSurgePak Surgical Prep/CarePak	chlorhexidine gluconate, mupirocin, dimethicone	Nucare Pharmaceuticals Inc	ANDA	Current
70859-057	NuSurgePak Surgical Prep/CarePak	chlorhexidine gluconate, mupirocin, dimethicone	Nucare Pharmaceuticals Inc	ANDA	Current
76413-158	Mupirocin	Mupirocin	Central Texas Community Health Centers	ANDA	Current
81033-020	Mupirocin	Mupirocin	Kesin Pharma Corporation	ANDA	Current