Mupirocin

Product NDC
70166-017
11-digit product format
701660017
Labeler code
70166
Product ID
70166-017_68f713f6-29df-20a5-e053-2991aa0a9e9d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mupirocin
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Lohxa
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
2020-12-31
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 productproduct70166-017IInactivated by FDA2026-08-17
excluded packagepackage70166-01770166-017-01IInactivated 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 · 30 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70166-017-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70166-017-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage70166-017-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage70166-017-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage70166-017-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage70166-017-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage70166-017-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage70166-017-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage70166-017-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage70166-017-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage70166-017-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage70166-017-01557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage70166-017-018af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage70166-017-01834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage70166-017-011332a3947898…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
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
70166-017-01Mupirocin50 in 1 CARTONOINTMENT501
70166-017-01Mupirocin1 g in 1 SYRINGE, PLASTICOINTMENT11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70166-017MUPIROCIN OINTMENT [LOHXA]1Legacy NDC, 2 package rows20180404_770fcfa2-d5e1-4e8e-bfa6-0bfc9d1677c3.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 OintmentPSN770fcfa2-d5e1-4e8e-bfa6-0bfc9d1677c31
106346mupirocin 0.02 MG/MG Topical OintmentSCD770fcfa2-d5e1-4e8e-bfa6-0bfc9d1677c31
106346mupirocin 2 % Topical OintmentSY770fcfa2-d5e1-4e8e-bfa6-0bfc9d1677c31
106346mupirocin 20 MG per GM Topical OintmentSY770fcfa2-d5e1-4e8e-bfa6-0bfc9d1677c31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70166-017-017016600170150 SYRINGE, PLASTIC in 1 CARTON (70166-017-01) > 1 g in 1 SYRINGE, PLASTIC2018-04-030000-00-00NoNoCurrent