Home NDC 62135-146 Nabumetone
Product NDC 62135-146
11-digit product format 621350146
Labeler code 62135
Product ID 62135-146_f2b77c4f-f185-76cb-e053-2995a90a6cc1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Nabumetone
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Chartwell RX, LLC
Application ANDA075280
Marketing category ANDA
Marketing start 2002-02-25
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 1 .
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 A075280-001 NABUMETONE NABUMETONE 500MG TABLET / ORAL AB 2002-02-25 A075280-002 NABUMETONE NABUMETONE 750MG TABLET / ORAL AB 2002-02-25
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 · 82 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 2026-02-19 14:30 UTC 2026-02 A075280-001 NABUMETONE 500MG TABLET / ORAL AB 2002-02-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075280-002 NABUMETONE 750MG TABLET / ORAL AB 2002-02-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075280-001 NABUMETONE 500MG TABLET / ORAL AB 2002-02-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075280-002 NABUMETONE 750MG TABLET / ORAL AB 2002-02-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075280-001 NABUMETONE 500MG TABLET / ORAL AB 2002-02-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075280-002 NABUMETONE 750MG TABLET / ORAL AB 2002-02-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075280-001 NABUMETONE 500MG TABLET / ORAL AB 2002-02-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075280-002 NABUMETONE 750MG TABLET / ORAL AB 2002-02-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075280-001 NABUMETONE 500MG TABLET / ORAL AB 2002-02-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075280-002 NABUMETONE 750MG TABLET / ORAL AB 2002-02-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075280-001 NABUMETONE 500MG TABLET / ORAL AB 2002-02-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075280-002 NABUMETONE 750MG TABLET / ORAL AB 2002-02-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075280-001 NABUMETONE 500MG TABLET / ORAL AB 2002-02-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075280-002 NABUMETONE 750MG TABLET / ORAL AB 2002-02-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075280-001 NABUMETONE 500MG TABLET / ORAL AB 2002-02-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075280-002 NABUMETONE 750MG TABLET / ORAL AB 2002-02-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075280-001 NABUMETONE 500MG TABLET / ORAL AB 2002-02-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075280-002 NABUMETONE 750MG TABLET / ORAL AB 2002-02-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075280-001 NABUMETONE 500MG TABLET / ORAL AB 2002-02-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075280-002 NABUMETONE 750MG TABLET / ORAL AB 2002-02-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075280-001 NABUMETONE 500MG TABLET / ORAL AB 2002-02-25 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075280-002 NABUMETONE 750MG TABLET / ORAL AB 2002-02-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075280-001 NABUMETONE 500MG TABLET / ORAL AB 2002-02-25 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075280-002 NABUMETONE 750MG TABLET / ORAL AB 2002-02-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075280-001 NABUMETONE 500MG TABLET / ORAL AB 2002-02-25 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075280-002 NABUMETONE 750MG TABLET / ORAL AB 2002-02-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075280-001 NABUMETONE 500MG TABLET / ORAL AB 2002-02-25 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A075280-002 NABUMETONE 750MG TABLET / ORAL AB 2002-02-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075280-001 NABUMETONE 500MG TABLET / ORAL AB 2002-02-25 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075280-002 NABUMETONE 750MG TABLET / ORAL AB 2002-02-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075280-001 NABUMETONE 500MG TABLET / ORAL AB 2002-02-25 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A075280-002 NABUMETONE 750MG TABLET / ORAL AB 2002-02-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075280-001 NABUMETONE 500MG TABLET / ORAL AB 2002-02-25 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A075280-002 NABUMETONE 750MG TABLET / ORAL AB 2002-02-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075280-001 NABUMETONE 500MG TABLET / ORAL AB 2002-02-25 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A075280-002 NABUMETONE 750MG TABLET / ORAL AB 2002-02-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075280-001 NABUMETONE 500MG TABLET / ORAL AB 2002-02-25 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A075280-002 NABUMETONE 750MG TABLET / ORAL AB 2002-02-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075280-001 NABUMETONE 500MG TABLET / ORAL AB 2002-02-25 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A075280-002 NABUMETONE 750MG TABLET / ORAL AB 2002-02-25 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 311892 Internal RxNorm lookup 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 62135-146-60 Nabumetone 60 in 1 BOTTLE TABLET, FILM COATED 60 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62135-146 NABUMETONE TABLET, FILM COATED [CHARTWELL RX, LLC] 1 Current NDC, 1 package rows 20230121_84bb2887-bab4-46ae-a07c-fa2a32c04b50.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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 62135-146-60 62135014660 60 TABLET, FILM COATED in 1 BOTTLE (62135-146-60) 2023-01-18 No No Current