Mupirocin

Product NDC
63187-151
11-digit product format
631870151
Labeler code
63187
Product ID
63187-151_a22d9ce1-ccc1-4955-939c-b74e110cffa5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mupirocin
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Proficient Rx LP
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
2026-12-31
Current FDA listing
Yes

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…

Additional Listing Data#

Finished product
Yes
Brand name base
Mupirocin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MUPIROCIN20 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
D0GX863OA5Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
106346Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
d8766748-6b53-4673-a3ee-5cd8a4301647Available on FDA.report

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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63187-151-222019-12-04C16284748780-19855e2a2-4bb4-60a7-e053-dbdaa90a05bdMupirocin Ointment USP, 2%
63187-151-222019-11-27C16284748780-19855e2a2-4bb4-60a7-e053-dbdaa90a05bdMupirocin Ointment USP, 2%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63187-151-22Mupirocin1 in 1 CARTONOINTMENT14
63187-151-22Mupirocin22 g in 1 TUBEOINTMENT224

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-151-22GM - Gram63187-15112c73070-ca87-4eee-a1c2-a49ab662680412015-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MupirocinACTIVE INGREDIENTD0GX863OA5MUPIROCIN OINTMENT [PROFICIENT RX LP]1
MupirocinACTIVE MOIETYD0GX863OA5MUPIROCIN OINTMENT [PROFICIENT RX LP]1
polyethylene glycol 3350INACTIVE INGREDIENTG2M7P15E5PMUPIROCIN OINTMENT [PROFICIENT RX LP]1
polyethylene glycol 400INACTIVE INGREDIENTB697894SGQMUPIROCIN OINTMENT [PROFICIENT RX LP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-151MUPIROCIN OINTMENT [PROFICIENT RX LP]4Current NDC, Legacy NDC, 2 package rows20230115_d8766748-6b53-4673-a3ee-5cd8a4301647.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
ndc (product): 63187-151

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
106346mupirocin 2 % Topical OintmentPSNd8766748-6b53-4673-a3ee-5cd8a43016474
106346mupirocin 0.02 MG/MG Topical OintmentSCDd8766748-6b53-4673-a3ee-5cd8a43016474
106346mupirocin 2 % Topical OintmentSYd8766748-6b53-4673-a3ee-5cd8a43016474
106346mupirocin 20 MG per GM Topical OintmentSYd8766748-6b53-4673-a3ee-5cd8a43016474

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-151-22631870151221 TUBE in 1 CARTON (63187-151-22) / 22 g in 1 TUBE1 tube2014-09-010000-00-00NoNoCurrent