Mupirocin

Product NDC: 80425-0254
11-digit product format: 804250254
Labeler code: 80425
Product ID: 80425-0254_2a9ae6d7-049c-3bd5-e063-6394a90a651e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Mupirocin
Dosage form: OINTMENT
Route: TOPICAL
Labeler: Advanced Rx Pharmacy of Tennessee, LLC
Application: ANDA065170
Marketing category: ANDA
Marketing start: 2023-01-11
Substance: MUPIROCIN
Active strength: 20 mg/g
Pharmacologic classes: RNA Synthetase Inhibitor Antibacterial [EPC], RNA Synthetase Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: 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
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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Mupirocin
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MUPIROCIN	20 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
D0GX863OA5	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
106346	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
f1a01044-8f2e-4e91-e053-2995a90af722	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f2f8c312-f164-6104-0de4-ec45484840e3	Product name	2	20260304
0c2e0212-b823-4ce8-611e-853ac2cac1b2	Product name	4	20230327
3db2f5c1-f78c-f062-515c-4827e36c2518	Product name	1	20140508
f74f326b-f453-01a0-e7e7-ce5ea9475503	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
80425-0254-1	Mupirocin	1 in 1 CARTON	OINTMENT	1		3
80425-0254-1	Mupirocin	22 g in 1 TUBE	OINTMENT	22		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
80425-0254-1	GM - Gram	80425-0254	c9925dc0-8cba-41e7-9bcc-06716cf3602f	1	2023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
80425-0254	MUPIROCIN OINTMENT [ADVANCED RX PHARMACY OF TENNESSEE, LLC]	3	Current NDC, Legacy NDC, 2 package rows	20250102_f1a01044-8f2e-4e91-e053-2995a90af722.zip

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
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
Mupirocin	MUPIROCIN	Lohxa	6d59e35c-b262-7940-e053-2991aa0a8908	2025-03-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065170 application number: ANDA065170
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
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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
D0GX863OA5	MUPIROCIN	12650-69-0	MUPIROCIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
106346	mupirocin 2 % Topical Ointment	PSN	f1a01044-8f2e-4e91-e053-2995a90af722	3
106346	mupirocin 0.02 MG/MG Topical Ointment	SCD	f1a01044-8f2e-4e91-e053-2995a90af722	3
106346	mupirocin 2 % Topical Ointment	SY	f1a01044-8f2e-4e91-e053-2995a90af722	3
106346	mupirocin 20 MG per GM Topical Ointment	SY	f1a01044-8f2e-4e91-e053-2995a90af722	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
80425-0254-1	80425025401	1 TUBE in 1 CARTON (80425-0254-1) / 22 g in 1 TUBE	1 tube	2023-01-11	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Mupirocin Ointment	Advanced Rx Pharmacy of Tennessee, LLC	2024-12-31	HUMAN PRESCRIPTION DRUG LABEL	3