mupirocin

Product NDC
49999-644
Requested package NDC
49999-644-22
11-digit product format
499990644
Labeler code
49999
Product ID
49999-644_d8c844e0-af7b-4475-9ec7-cca109bdd775
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mupirocin
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Lake Erie Medical DBA Quality Care Products LLC
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
2023-12-31
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 packagepackage49999-64449999-644-22DDiscontinued by firm2026-08-17

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage49999-64449999-644-22DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage49999-64449999-644-22DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49999-644-22GM - Gram49999-644bbfce767-0e55-4dbc-b4d6-7e6f87579e9a12016-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49999-644MUPIROCIN OINTMENT [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]41Legacy NDC20241218_6b52bdd7-0628-459d-a672-a8190e3e50ed.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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49999-644-22499990644221 TUBE in 1 CARTON (49999-644-22) > 22 g in 1 TUBE1 tube2009-10-300000-00-00NoNoCurrent