Mupirocin

Product NDC: 50268-568
Requested package NDC: 50268-568-15
11-digit product format: 502680568
Labeler code: 50268
Product ID: 50268-568_48d41df2-2bbc-ccd4-e063-6294a90a2c50
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Mupirocin
Dosage form: OINTMENT
Route: TOPICAL
Labeler: AvPAK
Application: ANDA065170
Marketing category: ANDA
Marketing start: 2019-06-11
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 1.

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 · 41 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
2026-02-19 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…`
2022-10-28 04:53 UTC	2022-10	A065170-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2005-09-23	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065170-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2005-09-23	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A065170-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2005-09-23	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
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…`
2022-10-28 04:53 UTC	2022-10	A065170-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065170-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A065170-001	AB	1	`cb3db0bc1861…`

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

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
8b10c706-ae9c-fc76-e053-2a95a90a4c73	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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50268-568-11	Mupirocin	50 g in 1 TUBE	OINTMENT	50		7
50268-568-15	Mupirocin	50 in 1 BOX	OINTMENT	50		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50268-568-11	GM - Gram	50268-568	0616efa7-6840-41ca-8b2c-053e559cc617	1	2019-11-12
50268-568-15	GM - Gram	50268-568	ff53c4aa-0185-4cda-a3fd-ae0a678d4a3c	1	2019-11-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50268-568	MUPIROCIN OINTMENT [AVPAK]	5	Current NDC, Legacy NDC, 2 package rows	20250313_8b10c706-ae9c-fc76-e053-2a95a90a4c73.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 · 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 ndc (package): 50268-568-15 ndc (product): 50268-568 ndc11 (package): 50268056815
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
106346	mupirocin 2 % Topical Ointment	PSN	8b10c706-ae9c-fc76-e053-2a95a90a4c73	7
106346	mupirocin 0.02 MG/MG Topical Ointment	SCD	8b10c706-ae9c-fc76-e053-2a95a90a4c73	7
106346	mupirocin 2 % Topical Ointment	SY	8b10c706-ae9c-fc76-e053-2a95a90a4c73	7
106346	mupirocin 20 MG per GM Topical Ointment	SY	8b10c706-ae9c-fc76-e053-2a95a90a4c73	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50268-568-15	50268056815	50 TUBE in 1 BOX (50268-568-15) / 50 g in 1 TUBE (50268-568-11)	50 tube	2019-06-11	0000-00-00	No	No	Current