Nabumetone

Product NDC
68788-7597
11-digit product format
687887597
Labeler code
68788
Product ID
68788-7597_a1eab4d1-416d-4fdf-aa75-93d17db5a253
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nabumetone
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA078420
Marketing category
ANDA
Marketing start
2020-02-13
Substance
NABUMETONE
Active strength
750 mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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 · 88 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A078420-001NABUMETONE500MGTABLET / ORALAB2008-09-24c2088c7a36db…
2026-10-15 13:18:302026-09A078420-002NABUMETONE750MGTABLET / ORALAB2008-09-24c2088c7a36db…
2026-09-14 22:38:342026-08A078420-001NABUMETONE500MGTABLET / ORALAB2008-09-2484e616aacf4f…
2026-09-14 22:38:342026-08A078420-002NABUMETONE750MGTABLET / ORALAB2008-09-2484e616aacf4f…
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…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09A078420-001AB1c2088c7a36db…
2026-10-15 13:18:302026-09A078420-002AB1c2088c7a36db…
2026-09-14 22:38:342026-08A078420-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A078420-002AB184e616aacf4f…
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…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Nabumetone
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NABUMETONE750 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
LW0TIW155ZInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
311893Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
455c9992-39a0-4353-a121-57e700c77942Available on FDA.report

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-7597-1Nabumetone100 in 1 BOTTLETABLET1005
68788-7597-2Nabumetone20 in 1 BOTTLETABLET205
68788-7597-3Nabumetone30 in 1 BOTTLETABLET305
68788-7597-6Nabumetone60 in 1 BOTTLETABLET605
68788-7597-8Nabumetone120 in 1 BOTTLETABLET1205
68788-7597-9Nabumetone90 in 1 BOTTLETABLET905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7597-1EA - Each68788-75973c78549b-cde7-45f0-b6de-2082e8ab3fe012020-04-20
68788-7597-2EA - Each68788-759753007ca8-c0cf-4b9e-a6c6-cc7fa3ff87b912020-04-20
68788-7597-3EA - Each68788-7597337e5ec1-726a-40a6-9ce9-93be59c696de12020-04-20
68788-7597-6EA - Each68788-7597e46d173b-a9af-4e40-89e0-b3a8d264e28b12020-04-20
68788-7597-8EA - Each68788-7597380bbafe-ff15-4103-8543-d812f3a4ef8712020-04-20
68788-7597-9EA - Each68788-7597326542ea-164a-467d-a0c8-259933e3ae5012020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7597NABUMETONE TABLET [PREFERRED PHARMACEUTICALS INC.]4Current NDC, Legacy NDC, 6 package rows20240724_455c9992-39a0-4353-a121-57e700c77942.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 2 of 2 · 34 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NabumetoneNABUMETONEPD-Rx Pharmaceuticals, Inc.69620c53-b37a-45b9-b560-221bbcd98fda2025-02-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078420
application number: ANDA078420
NABUMETONENABUMETONEdirect rxa8600b12-f180-0b27-e053-2995a90acbd92025-01-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078420
application number: ANDA078420
NabumetoneNABUMETONEScieGen Pharmaceuticals Inc80c6888d-03b4-44f3-b94d-bcf5154ceae52025-01-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078420
application number: ANDA078420
NabumetoneNABUMETONEAdvanced Rx of Tennessee, LLCaf9994ac-6687-2df2-e053-2995a90a959a2024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078420
application number: ANDA078420
NabumetoneNABUMETONEAdvanced Rx Pharmacy of Tennessee, LLCb43db4aa-6013-3942-e053-2a95a90a51892024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078420
application number: ANDA078420
NabumetoneNABUMETONEQuality Care Products, LLCda259c7c-6f1e-403c-b42b-596d53b61fe52024-12-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078420
application number: ANDA078420
NabumetoneNABUMETONEQuality Care Products, LLC065fdacc-739e-4b46-bebc-044b5c11bbbb2024-12-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078420
application number: ANDA078420
NabumetoneNABUMETONEA-S Medication Solutions26037234-daca-4f1a-a7a7-0871f77283f02024-11-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078420
application number: ANDA078420
NabumetoneNABUMETONEA-S Medication Solutionsd997d125-dfc5-4cc5-b7a6-03f5a7248d142024-10-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078420
application number: ANDA078420
NabumetoneNABUMETONEWestminster Pharmaceuticals, LLC264df44a-e294-4d9b-9113-92859cb08c202024-08-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078420
application number: ANDA078420
NabumetoneNABUMETONEBryant Ranch Prepack62f2e0bf-e5c8-480c-ac5e-401ced3bbc672024-08-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078420
application number: ANDA078420
NabumetoneNABUMETONEProficient Rx LP7a1643bf-6627-4b12-8246-6acc40517cf22022-05-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078420
application number: ANDA078420
NabumetoneNABUMETONEProficient Rx LPf4392863-ed3f-4fbd-8260-49827609aa2e2022-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078420
application number: ANDA078420
NabumetoneNABUMETONEAsclemed USA, Inc.04a71deb-2c9d-436c-a574-e5991b6a52482022-03-07Boxed 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 TabletPSN455c9992-39a0-4353-a121-57e700c779425
311893nabumetone 750 MG Oral TabletSCD455c9992-39a0-4353-a121-57e700c779425

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-7597-168788759701100 TABLET in 1 BOTTLE (68788-7597-1) 100 tablet2020-02-130000-00-00NoNoCurrent
68788-7597-26878875970220 TABLET in 1 BOTTLE (68788-7597-2) 20 tablet2020-02-130000-00-00NoNoCurrent
68788-7597-36878875970330 TABLET in 1 BOTTLE (68788-7597-3) 30 tablet2020-02-130000-00-00NoNoCurrent
68788-7597-66878875970660 TABLET in 1 BOTTLE (68788-7597-6) 60 tablet2020-02-130000-00-00NoNoCurrent
68788-7597-868788759708120 TABLET in 1 BOTTLE (68788-7597-8) 120 tablet2020-02-130000-00-00NoNoCurrent
68788-7597-96878875970990 TABLET in 1 BOTTLE (68788-7597-9) 90 tablet2020-02-130000-00-00NoNoCurrent