Home NDC 63187-307 Nabumetone
Product NDC 63187-307
11-digit product format 631870307
Labeler code 63187
Product ID 63187-307_9f61b1e1-ce31-45de-ab89-7ab579ee5878
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Nabumetone
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Proficient Rx LP
Application ANDA091083
Marketing category ANDA
Marketing start 2011-06-13
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 2026-12-31
Current FDA listing Yes 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A091083-001 NABUMETONE NABUMETONE 500MG TABLET / ORAL AB 2011-06-13 A091083-002 NABUMETONE NABUMETONE 750MG TABLET / ORAL AB 2011-06-13
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A091083-001 NABUMETONE 500MG TABLET / ORAL AB 2011-06-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A091083-002 NABUMETONE 750MG TABLET / ORAL AB 2011-06-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A091083-001 NABUMETONE 500MG TABLET / ORAL AB 2011-06-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091083-002 NABUMETONE 750MG TABLET / ORAL AB 2011-06-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091083-001 NABUMETONE 500MG TABLET / ORAL AB 2011-06-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091083-002 NABUMETONE 750MG TABLET / ORAL AB 2011-06-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091083-001 NABUMETONE 500MG TABLET / ORAL AB 2011-06-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091083-002 NABUMETONE 750MG TABLET / ORAL AB 2011-06-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091083-001 NABUMETONE 500MG TABLET / ORAL AB 2011-06-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091083-002 NABUMETONE 750MG TABLET / ORAL AB 2011-06-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091083-001 NABUMETONE 500MG TABLET / ORAL AB 2011-06-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091083-002 NABUMETONE 750MG TABLET / ORAL AB 2011-06-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091083-001 NABUMETONE 500MG TABLET / ORAL AB 2011-06-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091083-002 NABUMETONE 750MG TABLET / ORAL AB 2011-06-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091083-001 NABUMETONE 500MG TABLET / ORAL AB 2011-06-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091083-002 NABUMETONE 750MG TABLET / ORAL AB 2011-06-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091083-001 NABUMETONE 500MG TABLET / ORAL AB 2011-06-13 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091083-002 NABUMETONE 750MG TABLET / ORAL AB 2011-06-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091083-001 NABUMETONE 500MG TABLET / ORAL AB 2011-06-13 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091083-002 NABUMETONE 750MG TABLET / ORAL AB 2011-06-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091083-001 NABUMETONE 500MG TABLET / ORAL AB 2011-06-13 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A091083-002 NABUMETONE 750MG TABLET / ORAL AB 2011-06-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091083-001 NABUMETONE 500MG TABLET / ORAL AB 2011-06-13 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091083-002 NABUMETONE 750MG TABLET / ORAL AB 2011-06-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091083-001 NABUMETONE 500MG TABLET / ORAL AB 2011-06-13 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091083-002 NABUMETONE 750MG TABLET / ORAL AB 2011-06-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091083-001 NABUMETONE 500MG TABLET / ORAL AB 2011-06-13 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091083-002 NABUMETONE 750MG TABLET / ORAL AB 2011-06-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091083-001 NABUMETONE 500MG TABLET / ORAL AB 2011-06-13 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A091083-002 NABUMETONE 750MG TABLET / ORAL AB 2011-06-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091083-001 NABUMETONE 500MG TABLET / ORAL AB 2011-06-13 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091083-002 NABUMETONE 750MG TABLET / ORAL AB 2011-06-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A091083-001 NABUMETONE 500MG TABLET / ORAL AB 2011-06-13 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A091083-002 NABUMETONE 750MG TABLET / ORAL AB 2011-06-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A091083-001 NABUMETONE 500MG TABLET / ORAL AB 2011-06-13 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A091083-002 NABUMETONE 750MG TABLET / ORAL AB 2011-06-13 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A091083-001 NABUMETONE 500MG TABLET / ORAL AB 2011-06-13 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A091083-002 NABUMETONE 750MG TABLET / ORAL AB 2011-06-13 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A091083-001 NABUMETONE 500MG TABLET / ORAL AB 2011-06-13 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A091083-002 NABUMETONE 750MG TABLET / ORAL AB 2011-06-13 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Nabumetone
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NABUMETONE 750 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination LW0TIW155Z Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 311893 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63187-307-30 Nabumetone 30 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 30 3
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded NABUMETONE ACTIVE INGREDIENT LW0TIW155Z NABUMETONE TABLET, FILM COATED [PROFICIENT RX LP] 1 NABUMETONE ACTIVE MOIETY LW0TIW155Z NABUMETONE TABLET, FILM COATED [PROFICIENT RX LP] 1 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 NABUMETONE TABLET, FILM COATED [PROFICIENT RX LP] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO NABUMETONE TABLET, FILM COATED [PROFICIENT RX LP] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 NABUMETONE TABLET, FILM COATED [PROFICIENT RX LP] 1 POVIDONES INACTIVE INGREDIENT FZ989GH94E NABUMETONE TABLET, FILM COATED [PROFICIENT RX LP] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 NABUMETONE TABLET, FILM COATED [PROFICIENT RX LP] 1 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J NABUMETONE TABLET, FILM COATED [PROFICIENT RX LP] 1 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 NABUMETONE TABLET, FILM COATED [PROFICIENT RX LP] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ NABUMETONE TABLET, FILM COATED [PROFICIENT RX LP] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP NABUMETONE TABLET, FILM COATED [PROFICIENT RX LP] 1 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 NABUMETONE TABLET, FILM COATED [PROFICIENT RX LP] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63187-307 NABUMETONE TABLET, FILM COATED [PROFICIENT RX LP] 3 Current NDC, Legacy NDC, 1 package rows 20200131_079a8a9e-6d71-414a-83f3-ef68e323c1fd.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 · 5 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Nabumetone NABUMETONE Bryant Ranch Prepack 0186328f-3eb7-4407-bf9e-8007d08ebe7b 2025-09-23 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 091083 application number: ANDA091083 Nabumetone NABUMETONE Bryant Ranch Prepack dd0d2652-d335-45db-af43-5a2523f7299a 2025-09-18 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 091083 application number: ANDA091083 Nabumetone NABUMETONE Actavis Pharma, Inc. 53656d70-6572-4669-6465-6c6973555341 2025-07-07 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 091083 application number: ANDA091083 Nabumetone NABUMETONE Proficient Rx LP 0870c3c9-bfce-4722-8779-8775644196d3 2022-12-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 091083 application number: ANDA091083 Nabumetone NABUMETONE Proficient Rx LP 079a8a9e-6d71-414a-83f3-ef68e323c1fd 2020-01-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 091083 application number: ANDA091083 ndc (product): 63187-307
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 63187-307-30 63187030730 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63187-307-30) 2019-01-01 0000-00-00 No No Current