Home NDC 70954-784 Nabumetone
Product NDC 70954-784
11-digit product format 709540784
Labeler code 70954
Product ID 70954-784_e87289f4-d4f9-4510-aaa5-51f8f8167658
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Nabumetone
Dosage form TABLET, FILM COATED
Route ORAL
Labeler ANI Pharmaceuticals, Inc.
Application ANDA219118
Marketing category ANDA
Marketing start 2025-01-07
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 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 A219118-001 NABUMETONE NABUMETONE 500MG TABLET / ORAL AB 2025-01-07 A219118-002 NABUMETONE NABUMETONE 750MG TABLET / ORAL AB 2025-01-07
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 2026-08-18 06:07:40 2026-07 A219118-001 NABUMETONE 500MG TABLET / ORAL AB 2025-01-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A219118-002 NABUMETONE 750MG TABLET / ORAL AB 2025-01-07 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A219118-001 NABUMETONE 500MG TABLET / ORAL AB 2025-01-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A219118-002 NABUMETONE 750MG TABLET / ORAL AB 2025-01-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219118-001 NABUMETONE 500MG TABLET / ORAL AB 2025-01-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219118-002 NABUMETONE 750MG TABLET / ORAL AB 2025-01-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A219118-001 NABUMETONE 500MG TABLET / ORAL AB 2025-01-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A219118-002 NABUMETONE 750MG TABLET / ORAL AB 2025-01-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A219118-001 NABUMETONE 500MG TABLET / ORAL AB 2025-01-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A219118-002 NABUMETONE 750MG TABLET / ORAL AB 2025-01-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A219118-001 NABUMETONE 500MG TABLET / ORAL AB 2025-01-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A219118-002 NABUMETONE 750MG TABLET / ORAL AB 2025-01-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A219118-001 NABUMETONE 500MG TABLET / ORAL AB 2025-01-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A219118-002 NABUMETONE 750MG TABLET / ORAL AB 2025-01-07 03ed91905a0d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219118-001 NABUMETONE 500MG TABLET / ORAL AB 2025-01-07 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219118-002 NABUMETONE 750MG TABLET / ORAL AB 2025-01-07 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Nabumetone
Listing expiration 2027-12-31 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 70954-784-10 Nabumetone 100 in 1 BOTTLE TABLET, FILM COATED 100 1 70954-784-20 Nabumetone 500 in 1 BOTTLE TABLET, FILM COATED 500 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70954-784 NABUMETONE TABLET, FILM COATED [ANI PHARMACEUTICALS, INC.] 1 Current NDC, 2 package rows 20250112_e87289f4-d4f9-4510-aaa5-51f8f8167658.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 70954-784-10 70954078410 100 TABLET, FILM COATED in 1 BOTTLE (70954-784-10) 2025-01-07 No No Current 70954-784-20 70954078420 500 TABLET, FILM COATED in 1 BOTTLE (70954-784-20) 2025-01-07 No No Current