Home NDC 71205-378-30 Nabumetone
Product NDC 71205-378
Requested package NDC 71205-378-30
11-digit product format 712050378
Labeler code 71205
Product ID 71205-378_9490d3f2-d162-41b9-aad7-23aea8f5a500
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Nabumentone
Dosage form TABLET
Route ORAL
Labeler Proficient Rx LP
Application ANDA075280
Marketing category ANDA
Marketing start 2002-02-25
Marketing end 2022-07-31
Substance NABUMETONE
Active strength 750 mg/1
Pharmacologic classes Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag No
Listing certified through 0000-00-00
Current FDA listing Historical FDA.report record 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 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.
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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Nabumetone NABUMETONE Chartwell RX, LLC 84bb2887-bab4-46ae-a07c-fa2a32c04b50 2023-01-20 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 075280 application number: ANDA075280
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 71205-378-30 71205037830 30 TABLET in 1 BOTTLE (71205-378-30) 30 tablet 2020-01-03 2022-07-31 No No Current