Home NDC 68180-142 Nabumetone
Product NDC 68180-142
11-digit product format 681800142
Labeler code 68180
Product ID 68180-142_54834b73-96d1-4f73-953d-a3407be454d6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name nabumetone
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Lupin Pharmaceuticals, Inc.
Application ANDA090445
Marketing category ANDA
Marketing start 2011-01-12
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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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 A090445-001 NABUMETONE NABUMETONE 500MG TABLET / ORAL AB 2011-01-12 A090445-002 NABUMETONE NABUMETONE 750MG TABLET / ORAL AB 2011-01-12
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 A090445-001 NABUMETONE 500MG TABLET / ORAL AB 2011-01-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090445-002 NABUMETONE 750MG TABLET / ORAL AB 2011-01-12 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A090445-001 NABUMETONE 500MG TABLET / ORAL AB 2011-01-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090445-002 NABUMETONE 750MG TABLET / ORAL AB 2011-01-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090445-001 NABUMETONE 500MG TABLET / ORAL AB 2011-01-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090445-002 NABUMETONE 750MG TABLET / ORAL AB 2011-01-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090445-001 NABUMETONE 500MG TABLET / ORAL AB 2011-01-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090445-002 NABUMETONE 750MG TABLET / ORAL AB 2011-01-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090445-001 NABUMETONE 500MG TABLET / ORAL AB 2011-01-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090445-002 NABUMETONE 750MG TABLET / ORAL AB 2011-01-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090445-001 NABUMETONE 500MG TABLET / ORAL AB 2011-01-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090445-002 NABUMETONE 750MG TABLET / ORAL AB 2011-01-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090445-001 NABUMETONE 500MG TABLET / ORAL AB 2011-01-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090445-002 NABUMETONE 750MG TABLET / ORAL AB 2011-01-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090445-001 NABUMETONE 500MG TABLET / ORAL AB 2011-01-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090445-002 NABUMETONE 750MG TABLET / ORAL AB 2011-01-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090445-001 NABUMETONE 500MG TABLET / ORAL AB 2011-01-12 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090445-002 NABUMETONE 750MG TABLET / ORAL AB 2011-01-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090445-001 NABUMETONE 500MG TABLET / ORAL AB 2011-01-12 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090445-002 NABUMETONE 750MG TABLET / ORAL AB 2011-01-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090445-001 NABUMETONE 500MG TABLET / ORAL AB 2011-01-12 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A090445-002 NABUMETONE 750MG TABLET / ORAL AB 2011-01-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090445-001 NABUMETONE 500MG TABLET / ORAL AB 2011-01-12 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090445-002 NABUMETONE 750MG TABLET / ORAL AB 2011-01-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090445-001 NABUMETONE 500MG TABLET / ORAL AB 2011-01-12 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090445-002 NABUMETONE 750MG TABLET / ORAL AB 2011-01-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090445-001 NABUMETONE 500MG TABLET / ORAL AB 2011-01-12 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090445-002 NABUMETONE 750MG TABLET / ORAL AB 2011-01-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090445-001 NABUMETONE 500MG TABLET / ORAL AB 2011-01-12 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A090445-002 NABUMETONE 750MG TABLET / ORAL AB 2011-01-12 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090445-001 NABUMETONE 500MG TABLET / ORAL AB 2011-01-12 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090445-002 NABUMETONE 750MG TABLET / ORAL AB 2011-01-12 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090445-001 NABUMETONE 500MG TABLET / ORAL AB 2011-01-12 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A090445-002 NABUMETONE 750MG TABLET / ORAL AB 2011-01-12 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090445-001 NABUMETONE 500MG TABLET / ORAL AB 2011-01-12 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A090445-002 NABUMETONE 750MG TABLET / ORAL AB 2011-01-12 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090445-001 NABUMETONE 500MG TABLET / ORAL AB 2011-01-12 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A090445-002 NABUMETONE 750MG TABLET / ORAL AB 2011-01-12 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A090445-001 NABUMETONE 500MG TABLET / ORAL AB 2011-01-12 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A090445-002 NABUMETONE 750MG TABLET / ORAL AB 2011-01-12 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 · 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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68180-142-01 Nabumetone 100 in 1 BOTTLE TABLET, FILM COATED 100 4 68180-142-03 Nabumetone 1000 in 1 BOTTLE TABLET, FILM COATED 1000 4
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded NABUMETONE ACTIVE INGREDIENT LW0TIW155Z NABUMETONE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] 2 NABUMETONE ACTIVE MOIETY LW0TIW155Z NABUMETONE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U NABUMETONE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] 2 HYPROMELLOSE 2208 (3 MPA.S) INACTIVE INGREDIENT 9H4L916OBU NABUMETONE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] 2 HYPROMELLOSE 2910 (3 MPA.S) INACTIVE INGREDIENT 0VUT3PMY82 NABUMETONE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 NABUMETONE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] 2 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ NABUMETONE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 NABUMETONE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] 2 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J NABUMETONE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] 2 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 NABUMETONE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP NABUMETONE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68180-142 NABUMETONE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] 4 Current NDC, Legacy NDC, 2 package rows 20231104_cf96d189-5417-4181-a5fb-169b269560a2.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 Marketing end Sample Exclude flag Status 68180-142-01 68180014201 100 TABLET, FILM COATED in 1 BOTTLE (68180-142-01) 2011-01-12 0000-00-00 No No Current 68180-142-03 68180014203 1000 TABLET, FILM COATED in 1 BOTTLE (68180-142-03) 2011-01-12 0000-00-00 No No Current