Mupirocin

Product NDC: 50090-8170
11-digit product format: 500908170
Labeler code: 50090
Product ID: 50090-8170_02d8f858-c42d-4d02-87a0-5792c0710fd2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Mupirocin
Dosage form: OINTMENT
Route: TOPICAL
Labeler: A-S Medication Solutions
Application: ANDA065170
Marketing category: ANDA
Marketing start: 2005-09-23
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: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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 · 44 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
2026-10-15 13:18:30	2026-09	A065170-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2005-09-23	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A065170-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2005-09-23	`84e616aacf4f…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A065170-001	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A065170-001	AB	1	`84e616aacf4f…`
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…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Mupirocin
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MUPIROCIN	20 mg/g

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
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
50090-8170-0	50090817000	1 TUBE in 1 CARTON (50090-8170-0) / 22 g in 1 TUBE	1 tube	2026-10-28	No	No	Current