NABUMETONE

Product NDC
61919-159
11-digit product format
619190159
Labeler code
61919
Product ID
61919-159_9ca996d4-3b69-05db-e053-2995a90a9b81
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
NABUMETONE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
DIRECT RX
Application
ANDA075189
Marketing category
ANDA
Marketing start
2016-03-03
Marketing end
0000-00-00
Substance
NABUMETONE
Active strength
500 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 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct61919-159IInactivated by FDA2026-08-17
excluded productproduct61919-159IInactivated by FDA2026-08-17
excluded packagepackage61919-15961919-159-30IInactivated by FDA2026-08-17
excluded packagepackage61919-15961919-159-60IInactivated by FDA2026-08-17
excluded packagepackage61919-15961919-159-90IInactivated 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 2 · 102 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 productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage61919-159-60d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage61919-159-30d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage61919-159-90d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage61919-159-60f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage61919-159-30f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage61919-159-90f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage61919-159-602ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage61919-159-302ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage61919-159-902ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage61919-159-60a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage61919-159-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage61919-159-90a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage61919-159-60cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage61919-159-30cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage61919-159-90cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage61919-159-60cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage61919-159-30cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage61919-159-90cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage61919-159-60302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage61919-159-30302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage61919-159-90302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage61919-159-60ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage61919-159-30ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage61919-159-90ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage61919-159-600efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage61919-159-300efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage61919-159-900efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage61919-159-60ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage61919-159-30ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage61919-159-90ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage61919-159-60367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage61919-159-30367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage61919-159-90367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage61919-159-60557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage61919-159-30557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage61919-159-90557ba5c1ecfa…9c80585c8c6e…

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
A075189-001NABUMETONENABUMETONE500MGTABLET / ORAL2000-05-26
A075189-002NABUMETONENABUMETONE750MGTABLET / ORAL2001-09-24

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 06:07:402026-07A075189-001NABUMETONE500MGTABLET / ORAL2000-05-26caaa826d4ba7…
2026-08-18 06:07:402026-07A075189-002NABUMETONE750MGTABLET / ORAL2001-09-24caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075189-001NABUMETONE500MGTABLET / ORAL2000-05-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075189-002NABUMETONE750MGTABLET / ORAL2001-09-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075189-001NABUMETONE500MGTABLET / ORAL2000-05-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075189-002NABUMETONE750MGTABLET / ORAL2001-09-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08A075189-001NABUMETONE500MGTABLET / ORAL2000-05-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075189-002NABUMETONE750MGTABLET / ORAL2001-09-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075189-001NABUMETONE500MGTABLET / ORAL2000-05-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075189-002NABUMETONE750MGTABLET / ORAL2001-09-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075189-001NABUMETONE500MGTABLET / ORAL2000-05-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075189-002NABUMETONE750MGTABLET / ORAL2001-09-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075189-001NABUMETONE500MGTABLET / ORAL2000-05-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075189-002NABUMETONE750MGTABLET / ORAL2001-09-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075189-001NABUMETONE500MGTABLET / ORAL2000-05-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075189-002NABUMETONE750MGTABLET / ORAL2001-09-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075189-001NABUMETONE500MGTABLET / ORAL2000-05-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075189-002NABUMETONE750MGTABLET / ORAL2001-09-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075189-001NABUMETONE500MGTABLET / ORAL2000-05-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075189-002NABUMETONE750MGTABLET / ORAL2001-09-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075189-001NABUMETONE500MGTABLET / ORAL2000-05-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A075189-002NABUMETONE750MGTABLET / ORAL2001-09-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075189-001NABUMETONE500MGTABLET / ORAL2000-05-2679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075189-002NABUMETONE750MGTABLET / ORAL2001-09-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075189-001NABUMETONE500MGTABLET / ORAL2000-05-26301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075189-002NABUMETONE750MGTABLET / ORAL2001-09-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075189-001NABUMETONE500MGTABLET / ORAL2000-05-261e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075189-002NABUMETONE750MGTABLET / ORAL2001-09-241e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075189-001NABUMETONE500MGTABLET / ORAL2000-05-268072bd15b7f6…
2024-05-31 18:47 UTC2024-05A075189-002NABUMETONE750MGTABLET / ORAL2001-09-248072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075189-001NABUMETONE500MGTABLET / ORAL2000-05-265c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075189-002NABUMETONE750MGTABLET / ORAL2001-09-245c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075189-001NABUMETONE500MGTABLET / ORAL2000-05-265d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A075189-002NABUMETONE750MGTABLET / ORAL2001-09-245d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075189-001NABUMETONE500MGTABLET / ORAL2000-05-264b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A075189-002NABUMETONE750MGTABLET / ORAL2001-09-244b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075189-001NABUMETONE500MGTABLET / ORALAB2000-05-2674a2ff9319b5…
2019-12-13 00:20 UTC2019-12A075189-002NABUMETONE750MGTABLET / ORALABRS2001-09-2474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075189-001NABUMETONE500MGTABLET / ORAL2000-05-26bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A075189-002NABUMETONE750MGTABLET / ORAL2001-09-24bb7c543d1eb4…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A075189-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A075189-002AB174a2ff9319b5…
2019-12-14 00:12 UTC2019-12A075189-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A075189-002AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A075189-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A075189-002AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A075189-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A075189-002AB1ea99ee380514…

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
61919-159-90NABUMETONE90 in 1 BOTTLETABLET, FILM COATED903
61919-159-30NABUMETONE30 in 1 BOTTLETABLET, FILM COATED302
61919-159-60NABUMETONE60 in 1 BOTTLETABLET, FILM COATED602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-159-60EA - Each61919-15937591a8f-f4fc-498f-94cc-ab3983bf9ac812014-05-02
61919-159-90EA - Each61919-15969c3a1b0-de69-4792-8448-c51d1c374e0212018-03-08

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NABUMETONEACTIVE INGREDIENTLW0TIW155ZNABUMETONE TABLET, FILM COATED [DIRECT RX]2
NABUMETONEACTIVE MOIETYLW0TIW155ZNABUMETONE TABLET, FILM COATED [DIRECT RX]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UNABUMETONE TABLET, FILM COATED [DIRECT RX]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675NABUMETONE TABLET, FILM COATED [DIRECT RX]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTNABUMETONE TABLET, FILM COATED [DIRECT RX]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357NABUMETONE TABLET, FILM COATED [DIRECT RX]2
HYPROMELLOSE 2910 (3 MPA.S)INACTIVE INGREDIENT0VUT3PMY82NABUMETONE TABLET, FILM COATED [DIRECT RX]2
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4NABUMETONE TABLET, FILM COATED [DIRECT RX]2
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQNABUMETONE TABLET, FILM COATED [DIRECT RX]2
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WENABUMETONE TABLET, FILM COATED [DIRECT RX]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4NABUMETONE TABLET, FILM COATED [DIRECT RX]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JNABUMETONE TABLET, FILM COATED [DIRECT RX]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2NABUMETONE TABLET, FILM COATED [DIRECT RX]2
TALCINACTIVE INGREDIENT7SEV7J4R1UNABUMETONE TABLET, FILM COATED [DIRECT RX]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNABUMETONE TABLET, FILM COATED [DIRECT RX]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-159NABUMETONE TABLET, FILM COATED [DIRECT RX]3Legacy NDC, 1 package rows20200131_2d8f206e-0853-43ca-e054-00144ff8d46c.zip
61919-159NABUMETONE TABLET, FILM COATED [DIRECT RX]2Legacy NDC, 2 package rows20150829_3cbe54ab-137b-4a1d-8490-d9e826cccbfc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311892nabumetone 500 MG Oral TabletPSN2d8f206e-0853-43ca-e054-00144ff8d46c3
311892nabumetone 500 MG Oral TabletSCD2d8f206e-0853-43ca-e054-00144ff8d46c3
311892nabumetone 500 MG Oral TabletPSN3cbe54ab-137b-4a1d-8490-d9e826cccbfc2
311893nabumetone 750 MG Oral TabletPSN3cbe54ab-137b-4a1d-8490-d9e826cccbfc2
311892nabumetone 500 MG Oral TabletSCD3cbe54ab-137b-4a1d-8490-d9e826cccbfc2
311893nabumetone 750 MG Oral TabletSCD3cbe54ab-137b-4a1d-8490-d9e826cccbfc2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61919-159-306191901593030 in 1 BOTTLEHistorical
61919-159-606191901596060 in 1 BOTTLEHistorical
61919-159-906191901599090 TABLET, FILM COATED in 1 BOTTLE (61919-159-90) 2016-03-030000-00-00NoNoCurrent