mupirocin

Product NDC: 76420-128
11-digit product format: 764200128
Labeler code: 76420
Product ID: 76420-128_b3ba247a-da42-b643-e053-2a95a90aa969
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Mupirocin
Dosage form: OINTMENT
Route: TOPICAL
Labeler: Asclemed USA, Inc.
Application: ANDA065123
Marketing category: ANDA
Marketing start: 2009-10-30
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
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…`

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
b2ff9c56-ca19-48ca-bd08-4b33edb13a08	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
76420-128-22	mupirocin	22 g in 1 TUBE	OINTMENT	22		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
76420-128-22	GM - Gram	76420-128	21061d8d-6661-4952-8a40-3fac713071f3	1	2022-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76420-128	MUPIROCIN OINTMENT [ASCLEMED USA, INC.]	1	Current NDC, Legacy NDC, 1 package rows	20201112_b2ff9c56-ca19-48ca-bd08-4b33edb13a08.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 · 14 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
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
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
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
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
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
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
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
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

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	b2ff9c56-ca19-48ca-bd08-4b33edb13a08	1
106346	mupirocin 0.02 MG/MG Topical Ointment	SCD	b2ff9c56-ca19-48ca-bd08-4b33edb13a08	1
106346	mupirocin 2 % Topical Ointment	SY	b2ff9c56-ca19-48ca-bd08-4b33edb13a08	1
106346	mupirocin 20 MG per GM Topical Ointment	SY	b2ff9c56-ca19-48ca-bd08-4b33edb13a08	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
76420-128-22	76420012822	22 g in 1 TUBE (76420-128-22)	22 g	2020-11-10	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
mupirocin	Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	2020-11-09	HUMAN PRESCRIPTION DRUG LABEL	1