Nabumetone

Product NDC
68462-359
11-digit product format
684620359
Labeler code
68462
Product ID
68462-359_53eb632a-bd56-4079-b1cd-c0699b9bfc52
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nabumetone
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Glenmark Pharmaceuticals Inc., USA
Application
ANDA078671
Marketing category
ANDA
Marketing start
2008-03-01
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
2020-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68462-359DDiscontinued by firm2026-08-17
excluded packagepackage68462-35968462-359-01DDiscontinued by firm2026-08-17
excluded packagepackage68462-35968462-359-05DDiscontinued 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 · 36 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 packagepackage68462-359-05d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68462-359-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68462-359-05f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68462-359-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68462-359-052ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68462-359-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68462-359-05a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68462-359-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68462-359-05cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68462-359-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68462-359-05cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68462-359-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68462-359-05302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68462-359-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68462-359-05ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68462-359-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68462-359-050efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68462-359-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68462-359-05ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68462-359-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68462-359-05367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68462-359-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68462-359-05557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68462-359-01557ba5c1ecfa…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
A078671-001NABUMETONENABUMETONE500MGTABLET / ORALAB2008-03-07
A078671-002NABUMETONENABUMETONE750MGTABLET / ORALABRS2008-03-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A078671-001AB
A078671-002AB

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 06:07:402026-07A078671-001NABUMETONE500MGTABLET / ORALAB2008-03-07caaa826d4ba7…
2026-08-18 06:07:402026-07A078671-002NABUMETONE750MGTABLET / ORALABRS2008-03-07caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078671-001NABUMETONE500MGTABLET / ORALAB2008-03-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078671-002NABUMETONE750MGTABLET / ORALABRS2008-03-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078671-001NABUMETONE500MGTABLET / ORALAB2008-03-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078671-002NABUMETONE750MGTABLET / ORALABRS2008-03-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A078671-001NABUMETONE500MGTABLET / ORALAB2008-03-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078671-002NABUMETONE750MGTABLET / ORALABRS2008-03-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078671-001NABUMETONE500MGTABLET / ORALAB2008-03-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078671-002NABUMETONE750MGTABLET / ORALABRS2008-03-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078671-001NABUMETONE500MGTABLET / ORALAB2008-03-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078671-002NABUMETONE750MGTABLET / ORALABRS2008-03-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078671-001NABUMETONE500MGTABLET / ORALAB2008-03-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078671-002NABUMETONE750MGTABLET / ORALABRS2008-03-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078671-001NABUMETONE500MGTABLET / ORALAB2008-03-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078671-002NABUMETONE750MGTABLET / ORALABRS2008-03-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078671-001NABUMETONE500MGTABLET / ORALAB2008-03-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078671-002NABUMETONE750MGTABLET / ORALABRS2008-03-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078671-001NABUMETONE500MGTABLET / ORALAB2008-03-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078671-002NABUMETONE750MGTABLET / ORALABRS2008-03-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078671-001NABUMETONE500MGTABLET / ORALAB2008-03-07d06236e962d9…
2024-10-29 15:01 UTC2024-10A078671-002NABUMETONE750MGTABLET / ORALABRS2008-03-07d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078671-001NABUMETONE500MGTABLET / ORALAB2008-03-0779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078671-002NABUMETONE750MGTABLET / ORALABRS2008-03-0779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078671-001NABUMETONE500MGTABLET / ORALAB2008-03-07301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078671-002NABUMETONE750MGTABLET / ORALABRS2008-03-07301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078671-001NABUMETONE500MGTABLET / ORALAB2008-03-071e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078671-002NABUMETONE750MGTABLET / ORALABRS2008-03-071e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078671-001NABUMETONE500MGTABLET / ORALAB2008-03-078072bd15b7f6…
2024-05-31 18:47 UTC2024-05A078671-002NABUMETONE750MGTABLET / ORALABRS2008-03-078072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078671-001NABUMETONE500MGTABLET / ORALAB2008-03-075c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078671-002NABUMETONE750MGTABLET / ORALABRS2008-03-075c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078671-001NABUMETONE500MGTABLET / ORALAB2008-03-075d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A078671-002NABUMETONE750MGTABLET / ORALABRS2008-03-075d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078671-001NABUMETONE500MGTABLET / ORALAB2008-03-074b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A078671-002NABUMETONE750MGTABLET / ORALABRS2008-03-074b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078671-001NABUMETONE500MGTABLET / ORALAB2008-03-0774a2ff9319b5…
2019-12-13 00:20 UTC2019-12A078671-002NABUMETONE750MGTABLET / ORALAB2008-03-0774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078671-001NABUMETONE500MGTABLET / ORALAB2008-03-07bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A078671-002NABUMETONE750MGTABLET / ORALABRS2008-03-07bb7c543d1eb4…

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
2026-08-18 06:07:402026-07A078671-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078671-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078671-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078671-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078671-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078671-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078671-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078671-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078671-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078671-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078671-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078671-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078671-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078671-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078671-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078671-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078671-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078671-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078671-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078671-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078671-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078671-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078671-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078671-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078671-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078671-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078671-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078671-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078671-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A078671-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078671-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078671-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078671-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A078671-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078671-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A078671-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078671-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A078671-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078671-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A078671-002AB1bb7c543d1eb4…

DailyMed Product Concepts#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-359-01EA - Each68462-359b492d302-6bf7-4203-8cde-d91ab77b2e5812012-07-24
68462-359-05EA - Each68462-359a8497a4e-5873-45a5-9103-8af51e9c9b1c12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NABUMETONEACTIVE INGREDIENTLW0TIW155ZNABUMETONE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]5
NABUMETONEACTIVE MOIETYLW0TIW155ZNABUMETONE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UNABUMETONE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]5
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675NABUMETONE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]5
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTNABUMETONE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]5
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WONABUMETONE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NABUMETONE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]5
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ANABUMETONE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]5
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HNABUMETONE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4NABUMETONE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]5
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JNABUMETONE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNABUMETONE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]5
NABUMETONEACTIVE INGREDIENTLW0TIW155ZNABUMETONE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]3
NABUMETONEACTIVE INGREDIENTLW0TIW155ZNABUMETONE TABLET, FILM COATED [BRYANT RANCH PREPACK]3
NABUMETONEACTIVE MOIETYLW0TIW155ZNABUMETONE TABLET, FILM COATED [BRYANT RANCH PREPACK]3
NABUMETONEACTIVE MOIETYLW0TIW155ZNABUMETONE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UNABUMETONE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UNABUMETONE TABLET, FILM COATED [BRYANT RANCH PREPACK]3
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675NABUMETONE TABLET, FILM COATED [BRYANT RANCH PREPACK]3
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675NABUMETONE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]3
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTNABUMETONE TABLET, FILM COATED [BRYANT RANCH PREPACK]3
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTNABUMETONE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WONABUMETONE TABLET, FILM COATED [BRYANT RANCH PREPACK]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WONABUMETONE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NABUMETONE TABLET, FILM COATED [BRYANT RANCH PREPACK]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NABUMETONE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]3
POLYETHYLENE GLYCOL 200INACTIVE INGREDIENTR95B8J264JNABUMETONE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ANABUMETONE TABLET, FILM COATED [BRYANT RANCH PREPACK]3
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HNABUMETONE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4NABUMETONE TABLET, FILM COATED [BRYANT RANCH PREPACK]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4NABUMETONE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JNABUMETONE TABLET, FILM COATED [BRYANT RANCH PREPACK]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JNABUMETONE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2NABUMETONE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNABUMETONE TABLET, FILM COATED [BRYANT RANCH PREPACK]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNABUMETONE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]3
NABUMETONEACTIVE INGREDIENTLW0TIW155ZNABUMETONE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]2
NABUMETONEACTIVE INGREDIENTLW0TIW155ZNABUMETONE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]2
NABUMETONEACTIVE INGREDIENTLW0TIW155ZNABUMETONE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
NABUMETONEACTIVE INGREDIENTLW0TIW155ZNABUMETONE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]2
NABUMETONEACTIVE INGREDIENTLW0TIW155ZNABUMETONE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]2
NABUMETONEACTIVE MOIETYLW0TIW155ZNABUMETONE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]2
NABUMETONEACTIVE MOIETYLW0TIW155ZNABUMETONE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]2
NABUMETONEACTIVE MOIETYLW0TIW155ZNABUMETONE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]2
NABUMETONEACTIVE MOIETYLW0TIW155ZNABUMETONE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]2
NABUMETONEACTIVE MOIETYLW0TIW155ZNABUMETONE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UNABUMETONE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UNABUMETONE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UNABUMETONE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UNABUMETONE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675NABUMETONE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675NABUMETONE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675NABUMETONE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675NABUMETONE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTNABUMETONE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTNABUMETONE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTNABUMETONE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTNABUMETONE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WONABUMETONE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WONABUMETONE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WONABUMETONE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WONABUMETONE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NABUMETONE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NABUMETONE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NABUMETONE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NABUMETONE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]2
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1ANABUMETONE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1ANABUMETONE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]2
POLYETHYLENE GLYCOL 200INACTIVE INGREDIENTR95B8J264JNABUMETONE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ANABUMETONE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HNABUMETONE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HNABUMETONE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HNABUMETONE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4NABUMETONE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4NABUMETONE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4NABUMETONE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4NABUMETONE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JNABUMETONE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JNABUMETONE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JNABUMETONE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JNABUMETONE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2NABUMETONE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNABUMETONE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNABUMETONE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNABUMETONE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNABUMETONE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
NABUMETONEACTIVE INGREDIENTLW0TIW155ZNABUMETONE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
NABUMETONEACTIVE INGREDIENTLW0TIW155ZNABUMETONE TABLET, FILM COATED [STAT RX USA LLC]1
NABUMETONEACTIVE INGREDIENTLW0TIW155ZNABUMETONE TABLET, FILM COATED [RXCHANGE CO.]1
NABUMETONEACTIVE MOIETYLW0TIW155ZNABUMETONE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
NABUMETONEACTIVE MOIETYLW0TIW155ZNABUMETONE TABLET, FILM COATED [STAT RX USA LLC]1
NABUMETONEACTIVE MOIETYLW0TIW155ZNABUMETONE TABLET, FILM COATED [RXCHANGE CO.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UNABUMETONE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UNABUMETONE TABLET, FILM COATED [STAT RX USA LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UNABUMETONE TABLET, FILM COATED [RXCHANGE CO.]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675NABUMETONE TABLET, FILM COATED [RXCHANGE CO.]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675NABUMETONE TABLET, FILM COATED [STAT RX USA LLC]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675NABUMETONE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTNABUMETONE TABLET, FILM COATED [RXCHANGE CO.]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTNABUMETONE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTNABUMETONE TABLET, FILM COATED [STAT RX USA LLC]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WONABUMETONE TABLET, FILM COATED [RXCHANGE CO.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WONABUMETONE TABLET, FILM COATED [STAT RX USA LLC]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WONABUMETONE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NABUMETONE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NABUMETONE TABLET, FILM COATED [RXCHANGE CO.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NABUMETONE TABLET, FILM COATED [STAT RX USA LLC]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1ANABUMETONE TABLET, FILM COATED [STAT RX USA LLC]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ANABUMETONE TABLET, FILM COATED [RXCHANGE CO.]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ANABUMETONE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HNABUMETONE TABLET, FILM COATED [RXCHANGE CO.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4NABUMETONE TABLET, FILM COATED [STAT RX USA LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4NABUMETONE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4NABUMETONE TABLET, FILM COATED [RXCHANGE CO.]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JNABUMETONE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JNABUMETONE TABLET, FILM COATED [STAT RX USA LLC]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JNABUMETONE TABLET, FILM COATED [RXCHANGE CO.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNABUMETONE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNABUMETONE TABLET, FILM COATED [STAT RX USA LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNABUMETONE TABLET, FILM COATED [RXCHANGE CO.]1

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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NabumetoneNABUMETONENorthwind Health Company, LLCb088f564-43ff-8007-e053-2995a90ab0122026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078671
application number: ANDA078671
NabumetoneNABUMETONEAmerican Health Packaging0653b873-b74b-4ec6-b112-675760703d912025-11-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078671
application number: ANDA078671
NabumetoneNABUMETONEPD-Rx Pharmaceuticals, Inc.8f3c1b1d-2765-4cb5-92df-044b99339c922025-06-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078671
application number: ANDA078671
NabumetoneNABUMETONEExelan Pharmaceuticals Inc.16e76e29-9315-40c0-b1d6-8d91961063cf2025-03-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078671
application number: ANDA078671
NabumetoneNABUMETONECipla USA Inc.85954380-a520-46d7-89ac-e4b19d6e00a12025-03-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078671
application number: ANDA078671
NabumetoneNABUMETONEAdvanced Rx of Tennessee, LLCaf9969df-ce14-c0bc-e053-2995a90a3f592024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078671
application number: ANDA078671

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311892nabumetone 500 MG Oral TabletPSNa521e63f-9021-41a6-8f41-907b16caadd25
311893nabumetone 750 MG Oral TabletPSNa521e63f-9021-41a6-8f41-907b16caadd25
311892nabumetone 500 MG Oral TabletSCDa521e63f-9021-41a6-8f41-907b16caadd25
311893nabumetone 750 MG Oral TabletSCDa521e63f-9021-41a6-8f41-907b16caadd25
311893nabumetone 750 MG Oral TabletPSN1c6ea763-40f0-0cc9-e054-00144ff8d46c3
311893nabumetone 750 MG Oral TabletSCD1c6ea763-40f0-0cc9-e054-00144ff8d46c3
311892nabumetone 500 MG Oral TabletPSN87028b13-0aab-4e90-b92e-6b0c54e59bbb2
311892nabumetone 500 MG Oral TabletPSNb52901fa-5f7e-418b-aae5-842da76104342
311893nabumetone 750 MG Oral TabletPSN87028b13-0aab-4e90-b92e-6b0c54e59bbb2
311893nabumetone 750 MG Oral TabletPSN8c3ee7c0-02cb-1632-e053-2995a90ad4da2
311893nabumetone 750 MG Oral TabletPSNb52901fa-5f7e-418b-aae5-842da76104342
311892nabumetone 500 MG Oral TabletSCD87028b13-0aab-4e90-b92e-6b0c54e59bbb2
311892nabumetone 500 MG Oral TabletSCDb52901fa-5f7e-418b-aae5-842da76104342
311893nabumetone 750 MG Oral TabletSCD8c3ee7c0-02cb-1632-e053-2995a90ad4da2
311893nabumetone 750 MG Oral TabletSCD87028b13-0aab-4e90-b92e-6b0c54e59bbb2
311893nabumetone 750 MG Oral TabletSCDb52901fa-5f7e-418b-aae5-842da76104342
311892nabumetone 500 MG Oral TabletPSNe6a40890-d3ce-400c-a552-0d5ad28193c51
311893nabumetone 750 MG Oral TabletPSNe6a40890-d3ce-400c-a552-0d5ad28193c51
311893nabumetone 750 MG Oral TabletPSN11e2e5bf-c5bf-46db-920a-93711827aa5e1
311893nabumetone 750 MG Oral TabletPSNfcf0a35b-1679-4c13-abde-7afc7d5604841
311893nabumetone 750 MG Oral TabletPSN90b6d62f-6684-73bc-e053-2995a90a1a751
311893nabumetone 750 MG Oral TabletPSN90a2e268-bee6-498d-e053-2995a90ad52b1
311892nabumetone 500 MG Oral TabletSCDe6a40890-d3ce-400c-a552-0d5ad28193c51
311893nabumetone 750 MG Oral TabletSCD90b6d62f-6684-73bc-e053-2995a90a1a751
311893nabumetone 750 MG Oral TabletSCDe6a40890-d3ce-400c-a552-0d5ad28193c51
311893nabumetone 750 MG Oral TabletSCD90a2e268-bee6-498d-e053-2995a90ad52b1
311893nabumetone 750 MG Oral TabletSCD11e2e5bf-c5bf-46db-920a-93711827aa5e1
311893nabumetone 750 MG Oral TabletSCDfcf0a35b-1679-4c13-abde-7afc7d5604841

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68462-359-0168462035901100 TABLET, FILM COATED in 1 BOTTLE (68462-359-01) 2008-03-010000-00-00NoNoCurrent
68462-359-0568462035905500 TABLET, FILM COATED in 1 BOTTLE (68462-359-05) 2008-03-010000-00-00NoNoCurrent