Nabumetone

Product NDC
66267-482
11-digit product format
662670482
Labeler code
66267
Product ID
66267-482_b8a758ec-1555-d91b-e053-2a95a90a10e8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nabumetone
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA078671
Marketing category
ANDA
Marketing start
2008-03-01
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
2022-12-31
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 · 7 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct66267-482DDiscontinued by firm2026-08-17
excluded productproduct66267-482IInactivated by FDA2026-08-17
excluded packagepackage66267-48266267-482-03DDiscontinued by firm2026-08-17
excluded packagepackage66267-48266267-482-06DDiscontinued by firm2026-08-17
excluded packagepackage66267-48266267-482-09DDiscontinued by firm2026-08-17
excluded packagepackage66267-48266267-482-14IInactivated by FDA2026-08-17
excluded packagepackage66267-48266267-482-60IInactivated 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 2 · 105 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage66267-482-09DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage66267-482-14IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage66267-482-60IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage66267-482-03DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage66267-482-06DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage66267-482-09DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage66267-482-14IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage66267-482-60IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage66267-482-03DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage66267-482-06DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage66267-482-09DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage66267-482-14IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage66267-482-60IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage66267-482-03DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage66267-482-06DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage66267-482-09DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage66267-482-14IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage66267-482-60IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage66267-482-03DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage66267-482-06DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage66267-482-09DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage66267-482-14IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage66267-482-60IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage66267-482-03DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage66267-482-06DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage66267-482-09DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage66267-482-14IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage66267-482-60IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage66267-482-03DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage66267-482-06DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductDDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage66267-482-09DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage66267-482-14IInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage66267-482-60IInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage66267-482-03DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage66267-482-06DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductDDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage66267-482-09DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage66267-482-14IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage66267-482-60IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage66267-482-03DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage66267-482-06DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductDDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage66267-482-09DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage66267-482-14IInactivated by FDA0efc9e666f02…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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
66267-482-142021-01-29C16284748780-1ba0f9c33-0d84-a910-e053-dadaa90a0b85Nabumetone Tablets USP
66267-482-602021-01-29C16284748780-1ba0f9c33-0d84-a910-e053-dadaa90a0b85Nabumetone Tablets USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66267-482-14Nabumetone14 in 1 BOTTLETABLET, FILM COATED141
66267-482-60Nabumetone60 in 1 BOTTLETABLET, FILM COATED601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66267-482-60EA - Each66267-48276831e72-3628-45d8-a087-e94e93349c8412017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66267-482NABUMETONE TABLET, FILM COATED [NUCARE PHARMACEUTICALS, INC.]1Legacy NDC, 2 package rows20161220_415b168c-12c2-2777-e054-00144ff88e88.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 · 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 TabletPSN415b168c-12c2-2777-e054-00144ff88e881
311892nabumetone 500 MG Oral TabletSCD415b168c-12c2-2777-e054-00144ff88e881

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
66267-482-036626704820330 TABLET, FILM COATED in 1 BOTTLE (66267-482-03) 2017-07-250000-00-00NoNoCurrent
66267-482-066626704820660 TABLET, FILM COATED in 1 BOTTLE (66267-482-06) 2017-07-250000-00-00NoNoCurrent
66267-482-096626704820990 TABLET, FILM COATED in 1 BOTTLE (66267-482-09) 2017-07-250000-00-00NoNoCurrent
66267-482-146626704821414 in 1 BOTTLEHistorical
66267-482-606626704826060 in 1 BOTTLEHistorical