Mupirocin

Product NDC: 45865-722
11-digit product format: 458650722
Labeler code: 45865
Product ID: 45865-722_1fc12db9-6581-509b-e054-00144ff88e88
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Mupirocin
Dosage form: OINTMENT
Route: TOPICAL
Labeler: Medsource Pharmaceuticals
Application: ANDA065085
Marketing category: ANDA
Marketing start: 2003-11-07
Marketing end: 0000-00-00
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: 2020-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	45865-722		I	Inactivated by FDA		2026-08-17
excluded package	package	45865-722	45865-722-01	I	Inactivated by FDA		2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 18 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	45865-722-01	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	45865-722-01	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	45865-722-01	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	45865-722-01	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	45865-722-01	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	45865-722-01	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	45865-722-01	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	45865-722-01	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	45865-722-01	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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
A065085-001	MUPIROCIN	MUPIROCIN	2%	OINTMENT / TOPICAL	AB		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
A065085-001	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	A065085-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2003-11-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065085-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2003-11-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065085-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2003-11-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065085-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2003-11-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065085-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2003-11-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065085-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2003-11-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065085-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2003-11-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065085-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2003-11-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065085-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2003-11-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065085-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2003-11-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065085-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2003-11-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065085-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2003-11-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065085-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2003-11-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065085-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2003-11-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065085-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2003-11-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065085-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2003-11-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065085-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2003-11-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065085-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2003-11-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065085-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2003-11-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065085-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2003-11-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065085-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2003-11-07	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065085-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2003-11-07	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065085-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2003-11-07	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065085-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2003-11-07	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065085-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2003-11-07	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065085-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2003-11-07	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065085-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2003-11-07	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065085-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2003-11-07	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065085-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2003-11-07	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065085-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2003-11-07	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065085-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2003-11-07	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065085-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2003-11-07	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065085-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2003-11-07	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065085-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2003-11-07	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065085-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2003-11-07	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065085-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2003-11-07	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065085-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2003-11-07	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065085-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2003-11-07	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065085-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2003-11-07	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065085-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	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	A065085-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065085-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065085-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065085-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065085-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065085-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065085-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065085-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065085-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065085-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065085-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065085-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065085-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065085-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065085-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065085-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065085-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065085-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065085-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065085-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065085-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065085-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065085-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065085-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065085-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065085-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065085-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065085-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065085-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065085-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065085-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065085-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065085-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065085-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065085-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065085-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065085-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065085-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065085-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065085-001	AB	1	`e64feba35796…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f2f8c312-f164-6104-0de4-ec45484840e3	Product name	2	20260304
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
0c2e0212-b823-4ce8-611e-853ac2cac1b2	Product name	4	20230327
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
3db2f5c1-f78c-f062-515c-4827e36c2518	Product name	1	20140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508
f74f326b-f453-01a0-e7e7-ce5ea9475503	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
45865-722-01	2025-01-30	C162847	48780-1	2cef2736-b2f1-d83d-e063-dadaa90ab31f	MUPIROCIN OINTMENT USP, 2% 1010 For Dermatologic Use Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
45865-722-01	Mupirocin	22 g in 1 TUBE	OINTMENT	22		1
45865-722-01	Mupirocin	1 in 1 CARTON	OINTMENT	1		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MUPIROCIN	ACTIVE INGREDIENT	D0GX863OA5	MUPIROCIN OINTMENT [MEDSOURCE PHARMACEUTICALS]	1
MUPIROCIN	ACTIVE MOIETY	D0GX863OA5	MUPIROCIN OINTMENT [MEDSOURCE PHARMACEUTICALS]	1
POLYETHYLENE GLYCOL 3350	INACTIVE INGREDIENT	G2M7P15E5P	MUPIROCIN OINTMENT [MEDSOURCE PHARMACEUTICALS]	1
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	MUPIROCIN OINTMENT [MEDSOURCE PHARMACEUTICALS]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
45865-722	MUPIROCIN OINTMENT [MEDSOURCE PHARMACEUTICALS]	1	Legacy NDC, 2 package rows	20150915_1fc12db9-6580-509b-e054-00144ff88e88.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MUPIROCIN	MUPIROCIN	DIRECT RX	f88eea1a-2ba1-48bf-96c8-d96d18752aaa	2026-03-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065085 application number: ANDA065085
Mupirocin	MUPIROCIN	Advanced Rx Pharmacy of Tennessee, LLC	f1a048d9-af57-a4a2-e053-2995a90a8663	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065085 application number: ANDA065085
Mupirocin	MUPIROCIN	Proficient Rx LP	cbb18010-f3b5-4ed7-8c03-c9203f0e360e	2022-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065085 application number: ANDA065085
Mupirocin	MUPIROCIN	Teva Pharmaceuticals USA, Inc.	a543797a-2c1c-4ea3-bd6c-227a784f92d9	2022-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065085 application number: ANDA065085

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	1fc12db9-6580-509b-e054-00144ff88e88	1
106346	mupirocin 0.02 MG/MG Topical Ointment	SCD	1fc12db9-6580-509b-e054-00144ff88e88	1
106346	mupirocin 2 % Topical Ointment	SY	1fc12db9-6580-509b-e054-00144ff88e88	1
106346	mupirocin 20 MG per GM Topical Ointment	SY	1fc12db9-6580-509b-e054-00144ff88e88	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
45865-722-01	45865072201	1 TUBE in 1 CARTON (45865-722-01) > 22 g in 1 TUBE	1 tube	2003-11-07	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
MUPIROCIN OINTMENT USP, 2% 1010 For Dermatologic Use Rx only	Medsource Pharmaceuticals	2015-09-14	HUMAN PRESCRIPTION DRUG LABEL	1