mupirocin

Product NDC
50090-4397
Requested package NDC
50090-4397-1
11-digit product format
500904397
Labeler code
50090
Product ID
50090-4397_036900f5-7ccd-4d8b-a50a-6cc652fb3d47
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mupirocin
Dosage form
OINTMENT
Route
TOPICAL
Labeler
A-S Medication Solutions
Application
ANDA065123
Marketing category
ANDA
Marketing start
2009-10-30
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage50090-439750090-4397-1IInactivated 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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A065123-001MUPIROCINMUPIROCIN2%OINTMENT / TOPICALABRS2003-11-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A065123-001AB

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 06:07:402026-07A065123-001MUPIROCIN2%OINTMENT / TOPICALABRS2003-11-07caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A065123-001MUPIROCIN2%OINTMENT / TOPICALABRS2003-11-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065123-001MUPIROCIN2%OINTMENT / TOPICALABRS2003-11-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A065123-001MUPIROCIN2%OINTMENT / TOPICALABRS2003-11-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065123-001MUPIROCIN2%OINTMENT / TOPICALABRS2003-11-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065123-001MUPIROCIN2%OINTMENT / TOPICALABRS2003-11-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065123-001MUPIROCIN2%OINTMENT / TOPICALABRS2003-11-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065123-001MUPIROCIN2%OINTMENT / TOPICALABRS2003-11-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065123-001MUPIROCIN2%OINTMENT / TOPICALABRS2003-11-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065123-001MUPIROCIN2%OINTMENT / TOPICALABRS2003-11-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065123-001MUPIROCIN2%OINTMENT / TOPICALABRS2003-11-07d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065123-001MUPIROCIN2%OINTMENT / TOPICALABRS2003-11-0779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065123-001MUPIROCIN2%OINTMENT / TOPICALABRS2003-11-07301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065123-001MUPIROCIN2%OINTMENT / TOPICALABRS2003-11-071e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065123-001MUPIROCIN2%OINTMENT / TOPICALABRS2003-11-078072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065123-001MUPIROCIN2%OINTMENT / TOPICALABRS2003-11-075c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065123-001MUPIROCIN2%OINTMENT / TOPICALABRS2003-11-075d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065123-001MUPIROCIN2%OINTMENT / TOPICALABRS2003-11-074b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065123-001MUPIROCIN2%OINTMENT / TOPICALABRS2003-11-0774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065123-001MUPIROCIN2%OINTMENT / TOPICALABRS2003-11-07bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065123-001MUPIROCIN2%OINTMENT / TOPICALABRS2003-11-07782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A065123-001MUPIROCIN2%OINTMENT / TOPICALABRS2003-11-0787673890dc5c…
2021-03-12 10:30 UTC2021-03A065123-001MUPIROCIN2%OINTMENT / TOPICALABRS2003-11-075aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A065123-001MUPIROCIN2%OINTMENT / TOPICALABRS2003-11-078869cabd3fbd…
2020-11-12 02:37 UTC2020-11A065123-001MUPIROCIN2%OINTMENT / TOPICALABRS2003-11-07c0c555d07b60…
2019-12-14 00:12 UTC2019-12A065123-001MUPIROCIN2%OINTMENT / TOPICALABRS2003-11-073f01610625f2…
2019-09-15 20:21 UTC2019-09A065123-001MUPIROCIN2%OINTMENT / TOPICALABRS2003-11-07b00525d2431f…
2019-07-19 19:46 UTC2019-07A065123-001MUPIROCIN2%OINTMENT / TOPICALABRS2003-11-07ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A065123-001MUPIROCIN2%OINTMENT / TOPICALABRS2003-11-076a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A065123-001MUPIROCIN2%OINTMENT / TOPICALABRS2003-11-071c564ffb4f44…
2023-12-20 04:57 UTC2023-12A065123-001MUPIROCIN2%OINTMENT / TOPICALABRS2003-11-07ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A065123-001MUPIROCIN2%OINTMENT / TOPICALABRS2003-11-07a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A065123-001MUPIROCIN2%OINTMENT / TOPICALABRS2003-11-079b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A065123-001MUPIROCIN2%OINTMENT / TOPICALABRS2003-11-07a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A065123-001MUPIROCIN2%OINTMENT / TOPICALABRS2003-11-073f0d92c62455…
2023-05-13 08:27 UTC2023-05A065123-001MUPIROCIN2%OINTMENT / TOPICALABRS2003-11-07053a50430f4f…
2023-01-26 05:58 UTC2023-01A065123-001MUPIROCIN2%OINTMENT / TOPICALABRS2003-11-073bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A065123-001MUPIROCIN2%OINTMENT / TOPICALABRS2003-11-073a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A065123-001MUPIROCIN2%OINTMENT / TOPICALABRS2003-11-07f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A065123-001MUPIROCIN2%OINTMENT / TOPICALABRS2003-11-07e64feba35796…

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 06:07:402026-07A065123-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A065123-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065123-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A065123-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065123-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065123-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065123-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065123-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065123-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065123-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065123-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065123-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065123-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065123-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065123-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065123-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065123-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065123-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065123-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065123-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065123-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A065123-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A065123-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A065123-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A065123-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A065123-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A065123-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A065123-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A065123-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A065123-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A065123-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A065123-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A065123-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A065123-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A065123-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A065123-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A065123-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A065123-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A065123-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A065123-001AB1e64feba35796…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f2f8c312-f164-6104-0de4-ec45484840e3Product name220260304
0c2e0212-b823-4ce8-611e-853ac2cac1b2Product name420230327
3db2f5c1-f78c-f062-515c-4827e36c2518Product name120140508
f74f326b-f453-01a0-e7e7-ce5ea9475503Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4397-0mupirocin1 in 1 CARTONOINTMENT11
50090-4397-0mupirocin22 g in 1 TUBEOINTMENT221
50090-4397-1mupirocin1 in 1 CARTONOINTMENT11
50090-4397-1mupirocin22 g in 1 TUBEOINTMENT221

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4397MUPIROCIN OINTMENT [A-S MEDICATION SOLUTIONS]1Legacy NDC, 4 package rows20200825_99eb0412-1d5c-437f-902b-1bc195ae1efa.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
mupirocinMUPIROCINPreferred Pharmaceuticals Inc.6c9cd7fc-b72e-406e-b9aa-0f1bc035b8322026-07-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065123
application number: ANDA065123
mupirocinMUPIROCINHAWAII REPACK, INC.7eaa296c-3f98-4f11-b4c1-62c2bc22a9a12026-07-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065123
application number: ANDA065123
mupirocinMUPIROCINSt. Mary's Medical Park Pharmacy235c4f77-e751-a69f-e063-6394a90a1f962026-06-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065123
application number: ANDA065123
mupirocinMUPIROCINREMEDYREPACK INC.290b4e51-59b4-429a-987b-715ac817ef2c2026-01-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065123
application number: ANDA065123
mupirocinMUPIROCINBryant Ranch Prepack6cef3abf-9f17-459e-86b9-95896d9620b72025-10-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065123
application number: ANDA065123
mupirocinMUPIROCINBryant Ranch Prepack7e7675fb-4bfa-46ac-ac1b-0918593d63ee2025-10-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065123
application number: ANDA065123
mupirocinMUPIROCINATLANTIC BIOLOGICALS CORP.da2f7d4e-82c6-4790-8eea-3a97e5b307342025-05-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065123
application number: ANDA065123
MupirocinMUPIROCIN OINTMENTKesin Pharma Corporationb8e115ce-c8ff-4d08-b865-71dc4d0e51a12025-05-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065123
application number: ANDA065123
mupirocinMUPIROCINNuCare Pharmaceuticals,Inc.831060e6-17ef-b0a0-e053-2991aa0aeb4f2024-06-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065123
application number: ANDA065123
mupirocinMUPIROCINA-S Medication Solutionsa6c22c25-0f02-4c06-bbc2-723a18ecdda82024-01-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065123
application number: ANDA065123
mupirocinMUPIROCINPadagis Israel Pharmaceuticals Ltde9b61f01-3c67-42a4-a62b-10f1d13431902023-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065123
application number: ANDA065123
mupirocinMUPIROCINBryant Ranch Prepack1cd4c71f-138b-47c2-8ce8-9ac32408dc562023-07-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065123
application number: ANDA065123
mupirocinMUPIROCINProficient Rx LP97f8d67d-c422-4a26-9394-24a5ec9719d92022-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065123
application number: ANDA065123
mupirocinMUPIROCINAsclemed USA, Inc.b2ff9c56-ca19-48ca-bd08-4b33edb13a082020-11-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065123
application number: ANDA065123

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
106346mupirocin 2 % Topical OintmentPSN99eb0412-1d5c-437f-902b-1bc195ae1efa1
106346mupirocin 0.02 MG/MG Topical OintmentSCD99eb0412-1d5c-437f-902b-1bc195ae1efa1
106346mupirocin 2 % Topical OintmentSY99eb0412-1d5c-437f-902b-1bc195ae1efa1
106346mupirocin 20 MG per GM Topical OintmentSY99eb0412-1d5c-437f-902b-1bc195ae1efa1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-4397-1500904397011 TUBE in 1 CARTON (50090-4397-1) > 22 g in 1 TUBE1 tube2019-06-280000-00-00NoNoCurrent