Home NDC 79739-7076 Nabumetone 500 mg
Product NDC 79739-7076
11-digit product format 797397076
Labeler code 79739
Product ID 79739-7076_cf52d275-4853-4576-832a-07630bb644dc
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Nabumetone
Dosage form TABLET, FILM COATED
Route ORAL
Labeler LGM PHARMA SOLUTIONS, LLC
Application ANDA203166
Marketing category ANDA
Marketing start 2019-09-04
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 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A203166-001 NABUMETONE NABUMETONE 500MG TABLET / ORAL AB 2019-08-30 A203166-002 NABUMETONE NABUMETONE 750MG TABLET / ORAL AB 2019-08-30 A203166-003 NABUMETONE NABUMETONE 1GM TABLET / ORAL RS 2019-08-30
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 4 · 123 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 A203166-001 NABUMETONE 500MG TABLET / ORAL AB 2019-08-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203166-002 NABUMETONE 750MG TABLET / ORAL AB 2019-08-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203166-003 NABUMETONE 1GM TABLET / ORAL RS 2019-08-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A203166-001 NABUMETONE 500MG TABLET / ORAL AB 2019-08-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203166-002 NABUMETONE 750MG TABLET / ORAL AB 2019-08-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203166-003 NABUMETONE 1GM TABLET / ORAL RS 2019-08-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203166-001 NABUMETONE 500MG TABLET / ORAL AB 2019-08-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203166-002 NABUMETONE 750MG TABLET / ORAL AB 2019-08-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203166-003 NABUMETONE 1GM TABLET / ORAL 2019-08-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203166-001 NABUMETONE 500MG TABLET / ORAL AB 2019-08-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203166-002 NABUMETONE 750MG TABLET / ORAL AB 2019-08-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203166-003 NABUMETONE 1GM TABLET / ORAL 2019-08-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203166-001 NABUMETONE 500MG TABLET / ORAL AB 2019-08-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203166-002 NABUMETONE 750MG TABLET / ORAL AB 2019-08-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203166-003 NABUMETONE 1GM TABLET / ORAL 2019-08-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203166-001 NABUMETONE 500MG TABLET / ORAL AB 2019-08-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203166-002 NABUMETONE 750MG TABLET / ORAL AB 2019-08-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203166-003 NABUMETONE 1GM TABLET / ORAL 2019-08-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203166-001 NABUMETONE 500MG TABLET / ORAL AB 2019-08-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203166-002 NABUMETONE 750MG TABLET / ORAL AB 2019-08-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203166-003 NABUMETONE 1GM TABLET / ORAL 2019-08-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203166-001 NABUMETONE 500MG TABLET / ORAL AB 2019-08-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203166-002 NABUMETONE 750MG TABLET / ORAL AB 2019-08-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203166-003 NABUMETONE 1GM TABLET / ORAL 2019-08-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203166-001 NABUMETONE 500MG TABLET / ORAL AB 2019-08-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203166-002 NABUMETONE 750MG TABLET / ORAL AB 2019-08-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203166-003 NABUMETONE 1GM TABLET / ORAL 2019-08-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203166-001 NABUMETONE 500MG TABLET / ORAL AB 2019-08-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203166-002 NABUMETONE 750MG TABLET / ORAL AB 2019-08-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203166-003 NABUMETONE 1GM TABLET / ORAL 2019-08-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203166-001 NABUMETONE 500MG TABLET / ORAL AB 2019-08-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203166-002 NABUMETONE 750MG TABLET / ORAL AB 2019-08-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203166-003 NABUMETONE 1GM TABLET / ORAL 2019-08-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203166-001 NABUMETONE 500MG TABLET / ORAL AB 2019-08-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203166-002 NABUMETONE 750MG TABLET / ORAL AB 2019-08-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203166-003 NABUMETONE 1GM TABLET / ORAL 2019-08-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203166-001 NABUMETONE 500MG TABLET / ORAL AB 2019-08-30 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203166-002 NABUMETONE 750MG TABLET / ORAL AB 2019-08-30 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203166-003 NABUMETONE 1GM TABLET / ORAL 2019-08-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203166-001 NABUMETONE 500MG TABLET / ORAL AB 2019-08-30 1e350fbaab3a…
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 500 mg
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 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 311892 Internal RxNorm lookup 311893 Internal RxNorm lookup 427726 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 79739-7076-1 Nabumetone 500 mg 100 in 1 BOTTLE TABLET, FILM COATED 100 4 79739-7076-5 Nabumetone 500 mg 500 in 1 BOTTLE TABLET, FILM COATED 500 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 79739-7076 NABUMETONE 500 MG (NABUMETONE) TABLET, FILM COATED NABUMETONE 750 MG (NABUMETONE) TABLET, FILM COATED NABUMETONE 1000 MG (NABUMETONE) TABLET, FILM COATED [LGM PHARMA SOLUTIONS, LLC] 3 Current NDC, Legacy NDC, 2 package rows 20240123_ef7c3da8-797f-4ea9-8999-53509785a0f7.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 · 2 matching rows.
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 79739-7076-1 79739707601 100 TABLET, FILM COATED in 1 BOTTLE (79739-7076-1) 2019-09-04 0000-00-00 No No Current 79739-7076-5 79739707605 500 TABLET, FILM COATED in 1 BOTTLE (79739-7076-5) 2019-09-04 0000-00-00 No No Current