Mupirocin

Product NDC: 81033-020
11-digit product format: 810330020
Labeler code: 81033
Product ID: 81033-020_367aff21-2e11-43b6-b7cc-ce879476c1ce
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Mupirocin
Dosage form: OINTMENT
Route: TOPICAL
Labeler: Kesin Pharma Corporation
Application: ANDA090480
Marketing category: ANDA
Marketing start: 2021-10-15
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	81033-020		D	Discontinued by firm	2026-08-17
excluded package	package	81033-020	81033-020-50	D	Discontinued by firm	2026-08-17
excluded package	package	81033-020	81033-020-99	D	Discontinued by firm	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 · 3 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product	81033-020		I	Inactivated by FDA	excluded / ndc_excluded.zip	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	81033-020	81033-020-99	I	Inactivated by FDA	excluded / ndc_excluded.zip	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	81033-020	81033-020-50	I	Inactivated by FDA	excluded / ndc_excluded.zip	`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
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…`

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, Related label table
NDC	Effective	Related label
81033-020-50	2024-03-20	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
81033-020-99	2024-03-20	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
81033-020-50	2023-07-28	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
81033-020-99	2023-07-28	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	SPL version
81033-020-01	Mupirocin	1 g in 1 TUBE	OINTMENT	1	7
81033-020-50	Mupirocin	50 in 1 PACKAGE	OINTMENT	50	7
81033-020-99	Mupirocin	100 in 1 PACKAGE	OINTMENT	100	7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
81033-020-01	GM - Gram	81033-020	61dd1f57-348f-4d00-8a69-157d0da92fc1	1	2024-04-05
81033-020-50	GM - Gram	81033-020	29b83f55-39d8-4992-a617-0293247edb2c	1	2022-12-07
81033-020-99	GM - Gram	81033-020	e8db7979-0ddd-4980-b276-3a66b961ef85	1	2022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
81033-020	MUPIROCIN OINTMENT [KESIN PHARMA CORPORATION]	5	Legacy NDC, 3 package rows	20241027_b8e115ce-c8ff-4d08-b865-71dc4d0e51a1.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 · 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
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
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

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	b8e115ce-c8ff-4d08-b865-71dc4d0e51a1	7
106346	mupirocin 0.02 MG/MG Topical Ointment	SCD	b8e115ce-c8ff-4d08-b865-71dc4d0e51a1	7
106346	mupirocin 2 % Topical Ointment	SY	b8e115ce-c8ff-4d08-b865-71dc4d0e51a1	7
106346	mupirocin 20 MG per GM Topical Ointment	SY	b8e115ce-c8ff-4d08-b865-71dc4d0e51a1	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
81033-020-01	81033002001	1 g in 1 TUBE	1 g					Historical
81033-020-50	81033002050	50 TUBE in 1 PACKAGE (81033-020-50) > 1 g in 1 TUBE (81033-020-01)	50 tube	2021-10-15	0000-00-00	No	No	Current
81033-020-99	81033002099	100 TUBE in 1 PACKAGE (81033-020-99) > 1 g in 1 TUBE (81033-020-01)	100 tube	2021-10-15	0000-00-00	No	No	Current