Application 065123

Type: ANDA
Sponsor: PERRIGO ISRAEL

Application Products#

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

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
A065123-001	MUPIROCIN	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	RS	2003-11-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065123-001	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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A065123-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	RS	2003-11-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065123-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	RS	2003-11-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065123-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	RS	2003-11-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065123-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	RS	2003-11-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065123-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	RS	2003-11-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065123-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	RS	2003-11-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065123-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	RS	2003-11-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065123-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	RS	2003-11-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065123-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	RS	2003-11-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065123-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	RS	2003-11-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065123-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	RS	2003-11-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065123-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	RS	2003-11-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065123-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	RS	2003-11-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065123-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	RS	2003-11-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065123-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	RS	2003-11-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065123-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	RS	2003-11-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065123-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	RS	2003-11-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065123-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	RS	2003-11-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065123-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	RS	2003-11-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065123-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	RS	2003-11-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065123-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	RS	2003-11-07	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065123-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	RS	2003-11-07	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065123-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	RS	2003-11-07	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065123-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	RS	2003-11-07	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065123-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	RS	2003-11-07	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065123-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	RS	2003-11-07	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065123-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	RS	2003-11-07	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065123-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	RS	2003-11-07	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065123-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	RS	2003-11-07	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065123-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	RS	2003-11-07	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065123-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	RS	2003-11-07	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065123-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	RS	2003-11-07	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065123-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	RS	2003-11-07	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065123-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	RS	2003-11-07	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065123-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	RS	2003-11-07	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065123-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	RS	2003-11-07	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065123-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	RS	2003-11-07	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065123-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	RS	2003-11-07	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065123-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	RS	2003-11-07	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065123-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	RS	2003-11-07	`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	A065123-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065123-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065123-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065123-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065123-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065123-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065123-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065123-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065123-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065123-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065123-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065123-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065123-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065123-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065123-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065123-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065123-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065123-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065123-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065123-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065123-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065123-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065123-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065123-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065123-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065123-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065123-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065123-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065123-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065123-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065123-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065123-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065123-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065123-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065123-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065123-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065123-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065123-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065123-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065123-001	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 · 15 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
mupirocin	MUPIROCIN	Preferred Pharmaceuticals Inc.	6c9cd7fc-b72e-406e-b9aa-0f1bc035b832	2026-07-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065123 application number: ANDA065123
mupirocin	MUPIROCIN	HAWAII REPACK, INC.	7eaa296c-3f98-4f11-b4c1-62c2bc22a9a1	2026-07-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065123 application number: ANDA065123
mupirocin	MUPIROCIN	St. Mary's Medical Park Pharmacy	235c4f77-e751-a69f-e063-6394a90a1f96	2026-06-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065123 application number: ANDA065123
mupirocin	MUPIROCIN	REMEDYREPACK INC.	290b4e51-59b4-429a-987b-715ac817ef2c	2026-01-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065123 application number: ANDA065123 ndc (product): 70518-1808
mupirocin	MUPIROCIN	Bryant Ranch Prepack	6cef3abf-9f17-459e-86b9-95896d9620b7	2025-10-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065123 application number: ANDA065123
mupirocin	MUPIROCIN	Bryant Ranch Prepack	7e7675fb-4bfa-46ac-ac1b-0918593d63ee	2025-10-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065123 application number: ANDA065123
mupirocin	MUPIROCIN	ATLANTIC BIOLOGICALS CORP.	da2f7d4e-82c6-4790-8eea-3a97e5b30734	2025-05-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065123 application number: ANDA065123 ndc (product): 17856-0112
Mupirocin	MUPIROCIN OINTMENT	Kesin Pharma Corporation	b8e115ce-c8ff-4d08-b865-71dc4d0e51a1	2025-05-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065123 application number: ANDA065123
DermacinRx Clorhexacin	MUPIROCIN OINTMENT	PureTek Corporation	3c8cb9a6-58e5-4e8d-bfdc-1432a1bde6f9	2024-12-13	Warnings, Adverse reactions	Exact identifier ndc (product): 59088-391
mupirocin	MUPIROCIN	NuCare Pharmaceuticals,Inc.	831060e6-17ef-b0a0-e053-2991aa0aeb4f	2024-06-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065123 application number: ANDA065123 ndc (product): 68071-4789
mupirocin	MUPIROCIN	A-S Medication Solutions	a6c22c25-0f02-4c06-bbc2-723a18ecdda8	2024-01-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065123 application number: ANDA065123 ndc (product): 50090-1587
mupirocin	MUPIROCIN	Padagis Israel Pharmaceuticals Ltd	e9b61f01-3c67-42a4-a62b-10f1d1343190	2023-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065123 application number: ANDA065123 ndc (product): 45802-112
mupirocin	MUPIROCIN	Bryant Ranch Prepack	1cd4c71f-138b-47c2-8ce8-9ac32408dc56	2023-07-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065123 application number: ANDA065123 ndc (product): 63629-8687
mupirocin	MUPIROCIN	Proficient Rx LP	97f8d67d-c422-4a26-9394-24a5ec9719d9	2022-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065123 application number: ANDA065123 ndc (product): 63187-261
mupirocin	MUPIROCIN	Asclemed USA, Inc.	b2ff9c56-ca19-48ca-bd08-4b33edb13a08	2020-11-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065123 application number: ANDA065123 ndc (product): 76420-128

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 40 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
17856-0112	mupirocin	Mupirocin	Atlantic Biologicals Corps	ANDA	Current
17856-0112	mupirocin	Mupirocin	Atlantic Biologicals Corps	ANDA	Current
42254-229	mupirocin	Mupirocin	Rebel Distributors Corp	ANDA	Current
45802-112	mupirocin	Mupirocin	Padagis Israel Pharmaceuticals Ltd	ANDA	Current
45802-112	mupirocin	Mupirocin	Padagis Israel Pharmaceuticals Ltd	ANDA	Current
45802-112	mupirocin	Mupirocin	Perrigo New York Inc	ANDA	Current
45802-112	mupirocin	Mupirocin	Padagis Israel Pharmaceuticals Ltd	ANDA	Current
45802-112	mupirocin	Mupirocin	Perrigo New York Inc	ANDA	Current
49999-644	mupirocin	Mupirocin	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
49999-644	mupirocin	Mupirocin	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
50090-1587	mupirocin	Mupirocin	A-S Medication Solutions	ANDA	Current
50090-4349	mupirocin	Mupirocin	A-S Medication Solutions	ANDA	Current
50090-4397	mupirocin	Mupirocin	A-S Medication Solutions	ANDA	Current
50268-572	mupirocin	Mupirocin	AvPAK	ANDA	Current
50268-572	mupirocin	Mupirocin	AvPAK	ANDA	Current
50436-0112	mupirocin	Mupirocin	Unit Dose Services	ANDA	Current
52959-743	mupirocin	Mupirocin	H.J. Harkins Company, Inc.	ANDA	Current
53002-9853	mupirocin	Mupirocin	RPK Pharmaceuticals, Inc.	ANDA	Current
53225-5000	Pre and Post Sx Pouch	Mupirocin 2%, Dimethicone 5%, Chlorhexidine Gluconate 4%	Terrain Pharmaceuticals	ANDA	Current
59088-353	DermacinRx Surgical PharmaPak	Mupirocin Ointment Kit	PureTek Corporation	ANDA	Current
59088-353	DermacinRx Surgical PharmaPak	Mupirocin Ointment Kit	PureTek Corporation	ANDA	Current
59088-391	DermacinRx Clorhexacin	Mupirocin Ointment	PureTek Corporation	ANDA	Current
59088-391	DermacinRx Clorhexacin	Mupirocin Ointment	PureTek Corporation	ANDA	Current
61919-203	MUPIROCIN	MUPIROCIN	DirectRX	ANDA	Current
63187-261	mupirocin	Mupirocin	Proficient Rx LP	ANDA	Current
63187-261	mupirocin	Mupirocin	Proficient Rx LP	ANDA	Current
63187-261	mupirocin	Mupirocin	Proficient Rx LP	ANDA	Current
63629-8687	mupirocin	Mupirocin	Bryant Ranch Prepack	ANDA	Current
63629-8687	mupirocin	Mupirocin	Bryant Ranch Prepack	ANDA	Current
68071-4789	mupirocin	Mupirocin	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4789	mupirocin	Mupirocin	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-9891	mupirocin	Mupirocin	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9891	mupirocin	Mupirocin	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9891	mupirocin	Mupirocin	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9891	mupirocin	Mupirocin	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9891	mupirocin	Mupirocin	Preferred Pharmaceuticals, Inc.	ANDA	Current
69329-270	Dermawerx Surgical Plus Pak	Mupirocin Ointment Kit	Patchwerx Labs, Inc.	ANDA	Current
70518-1808	mupirocin	Mupirocin	REMEDYREPACK INC.	ANDA	Current
70518-1808	mupirocin	Mupirocin	REMEDYREPACK INC.	ANDA	Current
76420-128	mupirocin	Mupirocin	Asclemed USA, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
42811	ORIG	2007-04-02