Mupirocin

Product NDC: 50436-0025
Requested package NDC: 50436-0025-1
11-digit product format: 504360025
Labeler code: 50436
Product ID: 50436-0025_e96157c4-0225-49af-bc36-619831e61472
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: mupirocin
Dosage form: OINTMENT
Route: TOPICAL
Labeler: Unit Dose Services
Application: ANDA065192
Marketing category: ANDA
Marketing start: 2005-11-30
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: 2022-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	50436-0025	50436-0025-1	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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

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
A065192-001	MUPIROCIN	MUPIROCIN	2%	OINTMENT / TOPICAL	AB		2005-11-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065192-001	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	A065192-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2005-11-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065192-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2005-11-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065192-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2005-11-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065192-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2005-11-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065192-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2005-11-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065192-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2005-11-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065192-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2005-11-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065192-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2005-11-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065192-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2005-11-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065192-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2005-11-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065192-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2005-11-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065192-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2005-11-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065192-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2005-11-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065192-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2005-11-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065192-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2005-11-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065192-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2005-11-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065192-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2005-11-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065192-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2005-11-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065192-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2005-11-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065192-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2005-11-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065192-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2005-11-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065192-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2005-11-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065192-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2005-11-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065192-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2005-11-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065192-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2005-11-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065192-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2005-11-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065192-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2005-11-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065192-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2005-11-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065192-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2005-11-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065192-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2005-11-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065192-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2005-11-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065192-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2005-11-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065192-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2005-11-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065192-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2005-11-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065192-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2005-11-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065192-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2005-11-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065192-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2005-11-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065192-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2005-11-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065192-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2005-11-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065192-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2005-11-30	`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	A065192-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065192-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065192-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065192-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065192-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065192-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065192-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065192-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065192-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065192-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065192-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065192-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065192-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065192-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065192-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065192-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065192-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065192-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065192-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065192-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065192-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065192-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065192-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065192-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065192-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065192-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065192-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065192-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065192-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065192-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065192-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065192-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065192-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065192-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065192-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065192-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065192-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065192-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065192-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065192-001	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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50436-0025-1	2023-01-30	C162847	48780-1	f386c649-a4a4-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use MUPIROCIN Ointment safely and effectively. See full prescribing information for MUPIROCIN Ointment. MUPIROCIN ointment, for topical use Initial U.S. Approval: 1987

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50436-0025-1	Mupirocin	22 g in 1 BOTTLE	OINTMENT	22		8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50436-0025-1	GM - Gram	50436-0025	08d0983d-8b8d-4b2e-ad51-7cfc56272058	1	2014-12-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
mupirocin	ACTIVE INGREDIENT	D0GX863OA5	MUPIROCIN OINTMENT [UNIT DOSE SERVICES]	2
mupirocin	ACTIVE MOIETY	D0GX863OA5	MUPIROCIN OINTMENT [UNIT DOSE SERVICES]	2
polyethylene glycol 3350	INACTIVE INGREDIENT	G2M7P15E5P	MUPIROCIN OINTMENT [UNIT DOSE SERVICES]	2
polyethylene glycol 400	INACTIVE INGREDIENT	B697894SGQ	MUPIROCIN OINTMENT [UNIT DOSE SERVICES]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50436-0025	MUPIROCIN OINTMENT [UNIT DOSE SERVICES]	8	Legacy NDC, 1 package rows	20210829_f8ede7ba-fb90-4b3b-8f40-0914ae2e5a8c.zip

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	f8ede7ba-fb90-4b3b-8f40-0914ae2e5a8c	8
106346	mupirocin 0.02 MG/MG Topical Ointment	SCD	f8ede7ba-fb90-4b3b-8f40-0914ae2e5a8c	8
106346	mupirocin 2 % Topical Ointment	SY	f8ede7ba-fb90-4b3b-8f40-0914ae2e5a8c	8
106346	mupirocin 20 MG per GM Topical Ointment	SY	f8ede7ba-fb90-4b3b-8f40-0914ae2e5a8c	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50436-0025-1	50436002501	22 g in 1 BOTTLE (50436-0025-1)	22 g	2005-11-30	0000-00-00	No	No	Current