Nabumetone

Product NDC
45865-111
Requested package NDC
45865-111-60
11-digit product format
458650111
Labeler code
45865
Product ID
45865-111_b523dbfe-898f-c75b-e053-2a95a90a7ea2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nabumetone
Dosage form
TABLET
Route
ORAL
Labeler
Medsource Pharmaceuticals
Application
ANDA078420
Marketing category
ANDA
Marketing start
2020-07-01
Marketing end
0000-00-00
Substance
NABUMETONE
Active strength
750 mg/1
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
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 packagepackage45865-11145865-111-60IInactivated 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 · 9 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A078420-001NABUMETONENABUMETONE500MGTABLET / ORALAB2008-09-24
A078420-002NABUMETONENABUMETONE750MGTABLET / ORALAB2008-09-24

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A078420-001AB
A078420-002AB

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 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A078420-001NABUMETONE500MGTABLET / ORALAB2008-09-24caaa826d4ba7…
2026-08-18 06:07:402026-07A078420-002NABUMETONE750MGTABLET / ORALAB2008-09-24caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078420-001NABUMETONE500MGTABLET / ORALAB2008-09-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078420-002NABUMETONE750MGTABLET / ORALAB2008-09-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078420-001NABUMETONE500MGTABLET / ORALAB2008-09-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078420-002NABUMETONE750MGTABLET / ORALAB2008-09-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08A078420-001NABUMETONE500MGTABLET / ORALAB2008-09-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078420-002NABUMETONE750MGTABLET / ORALAB2008-09-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078420-001NABUMETONE500MGTABLET / ORALAB2008-09-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078420-002NABUMETONE750MGTABLET / ORALAB2008-09-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078420-001NABUMETONE500MGTABLET / ORALAB2008-09-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078420-002NABUMETONE750MGTABLET / ORALAB2008-09-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078420-001NABUMETONE500MGTABLET / ORALAB2008-09-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078420-002NABUMETONE750MGTABLET / ORALAB2008-09-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078420-001NABUMETONE500MGTABLET / ORALAB2008-09-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078420-002NABUMETONE750MGTABLET / ORALAB2008-09-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078420-001NABUMETONE500MGTABLET / ORALAB2008-09-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078420-002NABUMETONE750MGTABLET / ORALAB2008-09-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078420-001NABUMETONE500MGTABLET / ORALAB2008-09-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078420-002NABUMETONE750MGTABLET / ORALAB2008-09-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078420-001NABUMETONE500MGTABLET / ORALAB2008-09-24d06236e962d9…
2024-10-29 15:01 UTC2024-10A078420-002NABUMETONE750MGTABLET / ORALAB2008-09-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078420-001NABUMETONE500MGTABLET / ORALAB2008-09-2479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078420-002NABUMETONE750MGTABLET / ORALAB2008-09-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078420-001NABUMETONE500MGTABLET / ORALAB2008-09-24301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078420-002NABUMETONE750MGTABLET / ORALAB2008-09-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078420-001NABUMETONE500MGTABLET / ORALAB2008-09-241e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078420-002NABUMETONE750MGTABLET / ORALAB2008-09-241e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078420-001NABUMETONE500MGTABLET / ORALAB2008-09-248072bd15b7f6…
2024-05-31 18:47 UTC2024-05A078420-002NABUMETONE750MGTABLET / ORALAB2008-09-248072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078420-001NABUMETONE500MGTABLET / ORALAB2008-09-245c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078420-002NABUMETONE750MGTABLET / ORALAB2008-09-245c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078420-001NABUMETONE500MGTABLET / ORALAB2008-09-245d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A078420-002NABUMETONE750MGTABLET / ORALAB2008-09-245d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078420-001NABUMETONE500MGTABLET / ORALAB2008-09-244b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A078420-002NABUMETONE750MGTABLET / ORALAB2008-09-244b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078420-001NABUMETONE500MGTABLET / ORALAB2008-09-2474a2ff9319b5…
2019-12-13 00:20 UTC2019-12A078420-002NABUMETONE750MGTABLET / ORALAB2008-09-2474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078420-001NABUMETONE500MGTABLET / ORALAB2008-09-24bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A078420-002NABUMETONE750MGTABLET / ORALAB2008-09-24bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 80 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A078420-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078420-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078420-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078420-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078420-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078420-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078420-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078420-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078420-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078420-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078420-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078420-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078420-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078420-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078420-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078420-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078420-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078420-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078420-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078420-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078420-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078420-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078420-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078420-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078420-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078420-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078420-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078420-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078420-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A078420-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078420-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078420-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078420-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A078420-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078420-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A078420-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078420-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A078420-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078420-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A078420-002AB1bb7c543d1eb4…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9d4d18c4-d38e-37e1-df1c-ee38762bf8a5Product name420251024

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
45865-111-602025-01-30C16284748780-12cef2736-66eb-d83d-e063-dadaa90ab31fNabumetone Tablets USP Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45865-111-60Nabumetone60 in 1 BOTTLETABLET601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45865-111NABUMETONE TABLET [MEDSOURCE PHARMACEUTICALS]1Legacy NDC, 1 package rows20201128_b523da6c-bd32-7f41-e053-2995a90afc6a.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 2 · 33 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NabumetoneNABUMETONEPreferred Pharmaceuticals, Inc.95769e02-fa4a-4389-a2fa-3146eae025262026-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078420
application number: ANDA078420
NabumetoneNABUMETONEPreferred Pharmaceuticals Inc.455c9992-39a0-4353-a121-57e700c779422026-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078420
application number: ANDA078420
NabumetoneNABUMETONESt. Mary's Medical Park Pharmacy95aa8124-08fe-ff2f-e053-2a95a90a3c8f2026-06-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078420
application number: ANDA078420
NabumetoneNABUMETONEREMEDYREPACK INC.311ae656-55d2-4116-a1bd-6f4a4ce701852026-06-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078420
application number: ANDA078420
NabumetoneNABUMETONESt. Mary's Medical Park Pharmacy94930125-b792-579e-e053-2995a90ab6f92026-05-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078420
application number: ANDA078420
NabumetoneNABUMETONEREMEDYREPACK INC.6106afa3-e138-4b4d-8c13-992bf50620972026-02-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078420
application number: ANDA078420
NabumetoneNABUMETONENorthwind Health Company, LLCd9ca2484-7293-7db6-e053-2995a90a0f132026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078420
application number: ANDA078420
NabumetoneNABUMETONENorthwind Health Company, LLCda34003b-81a4-2efd-e053-2995a90a961c2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078420
application number: ANDA078420
NabumetoneNABUMETONERedpharm Drug3745775e-e11a-01db-e063-6294a90a9b522025-12-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078420
application number: ANDA078420
NabumetoneNABUMETONEPD-Rx Pharmaceuticals, Inc.75c51686-9c5e-4c13-acf4-2d04502eedda2025-12-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078420
application number: ANDA078420
NabumetoneNABUMETONEBryant Ranch Prepack583602ff-dbbe-4369-afa9-b917734ac9b12025-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078420
application number: ANDA078420
NabumetoneNABUMETONEBryant Ranch Prepackb2a41c0b-e2ad-4e14-a2f7-2049c12c35da2025-03-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078420
application number: ANDA078420
NabumetoneNABUMETONEBryant Ranch Prepackad9f2a34-6244-49b7-98ee-af18cb55693c2025-03-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078420
application number: ANDA078420
NabumetoneNABUMETONEBryant Ranch Prepack06f73fa8-7a8f-4160-939e-a25980a119062025-03-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078420
application number: ANDA078420
NabumetoneNABUMETONEBryant Ranch Prepack5a66c21f-4f06-4fb8-98fa-e81949586afd2025-03-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078420
application number: ANDA078420
NabumetoneNABUMETONEBryant Ranch Prepack419c597f-6a6f-4420-b240-7dc4c223387e2025-03-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078420
application number: ANDA078420
NabumetoneNABUMETONEBryant Ranch Prepacka4553637-498e-491a-982a-cff81b43aa6c2025-03-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078420
application number: ANDA078420
NabumetoneNABUMETONEBryant Ranch Prepack5ba602e9-846e-42b3-9ea6-fb461a9489472025-03-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078420
application number: ANDA078420
NabumetoneNABUMETONEBryant Ranch Prepack0be7ee60-2706-43ed-98ec-b89cd4e2b57c2025-03-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078420
application number: ANDA078420
NabumetoneNABUMETONEPD-Rx Pharmaceuticals, Inc.69620c53-b37a-45b9-b560-221bbcd98fda2025-02-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078420
application number: ANDA078420

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311893nabumetone 750 MG Oral TabletPSNb523da6c-bd32-7f41-e053-2995a90afc6a1
311893nabumetone 750 MG Oral TabletSCDb523da6c-bd32-7f41-e053-2995a90afc6a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45865-111-604586501116060 TABLET in 1 BOTTLE (45865-111-60) 60 tablet2020-07-010000-00-00NoNoCurrent