Mupirocin

Product NDC
53002-9851
11-digit product format
530029851
Labeler code
53002
Product ID
53002-9851_2dc44d72-8b34-4fbd-8aaa-5a21f03e4f77
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mupirocin
Dosage form
OINTMENT
Route
TOPICAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA065170
Marketing category
ANDA
Marketing start
2005-09-23
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
2021-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct53002-9851IInactivated by FDA2026-08-17
excluded packagepackage53002-985153002-9851-1IInactivated by FDA2026-08-17

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 · 22 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage53002-9851-1IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage53002-9851-1IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage53002-9851-1IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage53002-9851-1IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage53002-9851-1IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage53002-9851-1IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductUExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage53002-9851-1UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductUExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage53002-9851-1UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductUExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage53002-9851-1UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage53002-9851-1IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage53002-9851-1IInactivated by FDA9bebd1f3094a…5416666fcb17…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A065170-001MUPIROCINMUPIROCIN2%OINTMENT / TOPICALAB2005-09-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A065170-001AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A065170-001MUPIROCIN2%OINTMENT / TOPICALAB2005-09-23caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A065170-001MUPIROCIN2%OINTMENT / TOPICALAB2005-09-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065170-001MUPIROCIN2%OINTMENT / TOPICALAB2005-09-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A065170-001MUPIROCIN2%OINTMENT / TOPICALAB2005-09-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065170-001MUPIROCIN2%OINTMENT / TOPICALAB2005-09-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065170-001MUPIROCIN2%OINTMENT / TOPICALAB2005-09-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065170-001MUPIROCIN2%OINTMENT / TOPICALAB2005-09-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065170-001MUPIROCIN2%OINTMENT / TOPICALAB2005-09-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065170-001MUPIROCIN2%OINTMENT / TOPICALAB2005-09-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065170-001MUPIROCIN2%OINTMENT / TOPICALAB2005-09-23d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065170-001MUPIROCIN2%OINTMENT / TOPICALAB2005-09-23d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065170-001MUPIROCIN2%OINTMENT / TOPICALAB2005-09-2379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065170-001MUPIROCIN2%OINTMENT / TOPICALAB2005-09-23301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065170-001MUPIROCIN2%OINTMENT / TOPICALAB2005-09-231e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065170-001MUPIROCIN2%OINTMENT / TOPICALAB2005-09-238072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065170-001MUPIROCIN2%OINTMENT / TOPICALAB2005-09-235c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065170-001MUPIROCIN2%OINTMENT / TOPICALAB2005-09-235d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065170-001MUPIROCIN2%OINTMENT / TOPICALAB2005-09-234b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065170-001MUPIROCIN2%OINTMENT / TOPICALAB2005-09-2374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065170-001MUPIROCIN2%OINTMENT / TOPICALAB2005-09-23bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065170-001MUPIROCIN2%OINTMENT / TOPICALAB2005-09-23782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A065170-001MUPIROCIN2%OINTMENT / TOPICALAB2005-09-2387673890dc5c…
2021-03-12 10:30 UTC2021-03A065170-001MUPIROCIN2%OINTMENT / TOPICALAB2005-09-235aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A065170-001MUPIROCIN2%OINTMENT / TOPICALAB2005-09-238869cabd3fbd…
2020-11-12 02:37 UTC2020-11A065170-001MUPIROCIN2%OINTMENT / TOPICALAB2005-09-23c0c555d07b60…
2019-12-14 00:12 UTC2019-12A065170-001MUPIROCIN2%OINTMENT / TOPICALAB2005-09-233f01610625f2…
2019-09-15 20:21 UTC2019-09A065170-001MUPIROCIN2%OINTMENT / TOPICALAB2005-09-23b00525d2431f…
2019-07-19 19:46 UTC2019-07A065170-001MUPIROCIN2%OINTMENT / TOPICALAB2005-09-23ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A065170-001MUPIROCIN2%OINTMENT / TOPICALAB2005-09-236a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A065170-001MUPIROCIN2%OINTMENT / TOPICALAB2005-09-231c564ffb4f44…
2023-12-20 04:57 UTC2023-12A065170-001MUPIROCIN2%OINTMENT / TOPICALAB2005-09-23ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A065170-001MUPIROCIN2%OINTMENT / TOPICALAB2005-09-23a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A065170-001MUPIROCIN2%OINTMENT / TOPICALAB2005-09-239b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A065170-001MUPIROCIN2%OINTMENT / TOPICALAB2005-09-23a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A065170-001MUPIROCIN2%OINTMENT / TOPICALAB2005-09-233f0d92c62455…
2023-05-13 08:27 UTC2023-05A065170-001MUPIROCIN2%OINTMENT / TOPICALAB2005-09-23053a50430f4f…
2023-01-26 05:58 UTC2023-01A065170-001MUPIROCIN2%OINTMENT / TOPICALAB2005-09-233bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A065170-001MUPIROCIN2%OINTMENT / TOPICALAB2005-09-233a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A065170-001MUPIROCIN2%OINTMENT / TOPICALAB2005-09-23f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A065170-001MUPIROCIN2%OINTMENT / TOPICALAB2005-09-23e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A065170-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A065170-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065170-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A065170-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065170-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065170-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065170-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065170-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065170-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065170-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065170-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065170-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065170-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065170-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065170-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065170-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065170-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065170-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065170-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065170-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065170-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A065170-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A065170-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A065170-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A065170-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A065170-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A065170-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A065170-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A065170-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A065170-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A065170-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A065170-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A065170-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A065170-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A065170-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A065170-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A065170-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A065170-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A065170-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A065170-001AB1e64feba35796…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f2f8c312-f164-6104-0de4-ec45484840e3Product name220260304
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
0c2e0212-b823-4ce8-611e-853ac2cac1b2Product name420230327
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
3db2f5c1-f78c-f062-515c-4827e36c2518Product name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508
f74f326b-f453-01a0-e7e7-ce5ea9475503Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-9851-1Mupirocin22 g in 1 TUBEOINTMENT225

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-9851MUPIROCIN OINTMENT [RPK PHARMACEUTICALS, INC.]5Legacy NDC, 1 package rows20230609_f41c04f9-33fb-47ae-a54d-a4292e559784.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MupirocinMUPIROCINSportpharm LLCc70dd5d7-6995-4a3d-b19c-9b4a2cfe3da92026-05-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065170
application number: ANDA065170
MupirocinMUPIROCINPAI Holdings, LLC dba PAI Pharmaa822d44d-c651-406c-a2b9-aa8fbe8f89ce2026-03-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065170
application number: ANDA065170
MupirocinMUPIROCINAvPAK8b10c706-ae9c-fc76-e053-2a95a90a4c732026-01-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065170
application number: ANDA065170
MupirocinMUPIROCINSun Pharmaceutical Industries, Inc.900bb675-2f03-47e3-854e-257ec48313322025-07-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065170
application number: ANDA065170
MupirocinMUPIROCINLohxa6d59e35c-b262-7940-e053-2991aa0a89082025-03-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065170
application number: ANDA065170
MupirocinMUPIROCINAdvanced Rx Pharmacy of Tennessee, LLCf1a01044-8f2e-4e91-e053-2995a90af7222024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065170
application number: ANDA065170
MupirocinMUPIROCINNuCare Pharmaceuticals,Inc.66db1071-024f-aa19-e053-2a91aa0a8e392024-06-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065170
application number: ANDA065170
MupirocinMUPIROCINProficient Rx LPd8766748-6b53-4673-a3ee-5cd8a43016472023-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065170
application number: ANDA065170

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
106346mupirocin 2 % Topical OintmentPSNf41c04f9-33fb-47ae-a54d-a4292e5597845
106346mupirocin 0.02 MG/MG Topical OintmentSCDf41c04f9-33fb-47ae-a54d-a4292e5597845
106346mupirocin 2 % Topical OintmentSYf41c04f9-33fb-47ae-a54d-a4292e5597845
106346mupirocin 20 MG per GM Topical OintmentSYf41c04f9-33fb-47ae-a54d-a4292e5597845

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-9851-15300298510122 g in 1 TUBE (53002-9851-1) 22 g2018-10-010000-00-00NoNoCurrent