Home NDC 62135-145 Nabumetone
Product NDC 62135-145
11-digit product format 621350145
Labeler code 62135
Product ID 62135-145_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 500 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.
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 2026-08-01 22:54:32 2026-06 A075280-001 NABUMETONE 500MG TABLET / ORAL AB 2002-02-25 a50c72e98297…2026-08-01 22:54:32 2026-06 A075280-002 NABUMETONE 750MG TABLET / ORAL AB 2002-02-25 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 A075280-001 AB 1 a50c72e98297…2026-08-01 22:54:32 2026-06 A075280-002 AB 1 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Nabumetone
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NABUMETONE 500 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 62135-145-60 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 62135-145 NABUMETONE TABLET, FILM COATED [CHARTWELL RX, LLC] 1 Current NDC, 1 package rows 20230121_84bb2887-bab4-46ae-a07c-fa2a32c04b50.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 62135-145-60 62135014560 60 TABLET, FILM COATED in 1 BOTTLE (62135-145-60) 2023-01-18 No No Current