Home NDC 71335-1234 Nabumetone
Product NDC 71335-1234
11-digit product format 713351234
Labeler code 71335
Product ID 71335-1234_8b05e389-e1cc-47d1-b24e-10f247ca7f14
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Nabumetone
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA091083
Marketing category ANDA
Marketing start 2011-06-13
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 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 3 · 140 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 A091083-001 NABUMETONE NABUMETONE 500MG TABLET / ORAL AB 2011-06-13 A091083-002 NABUMETONE NABUMETONE 750MG TABLET / ORAL AB 2011-06-13
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 A091083-001 NABUMETONE 500MG TABLET / ORAL AB 2011-06-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A091083-002 NABUMETONE 750MG TABLET / ORAL AB 2011-06-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A091083-001 NABUMETONE 500MG TABLET / ORAL AB 2011-06-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091083-002 NABUMETONE 750MG TABLET / ORAL AB 2011-06-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091083-001 NABUMETONE 500MG TABLET / ORAL AB 2011-06-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091083-002 NABUMETONE 750MG TABLET / ORAL AB 2011-06-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091083-001 NABUMETONE 500MG TABLET / ORAL AB 2011-06-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091083-002 NABUMETONE 750MG TABLET / ORAL AB 2011-06-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091083-001 NABUMETONE 500MG TABLET / ORAL AB 2011-06-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091083-002 NABUMETONE 750MG TABLET / ORAL AB 2011-06-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091083-001 NABUMETONE 500MG TABLET / ORAL AB 2011-06-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091083-002 NABUMETONE 750MG TABLET / ORAL AB 2011-06-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091083-001 NABUMETONE 500MG TABLET / ORAL AB 2011-06-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091083-002 NABUMETONE 750MG TABLET / ORAL AB 2011-06-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091083-001 NABUMETONE 500MG TABLET / ORAL AB 2011-06-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091083-002 NABUMETONE 750MG TABLET / ORAL AB 2011-06-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091083-001 NABUMETONE 500MG TABLET / ORAL AB 2011-06-13 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091083-002 NABUMETONE 750MG TABLET / ORAL AB 2011-06-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091083-001 NABUMETONE 500MG TABLET / ORAL AB 2011-06-13 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091083-002 NABUMETONE 750MG TABLET / ORAL AB 2011-06-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091083-001 NABUMETONE 500MG TABLET / ORAL AB 2011-06-13 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A091083-002 NABUMETONE 750MG TABLET / ORAL AB 2011-06-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091083-001 NABUMETONE 500MG TABLET / ORAL AB 2011-06-13 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091083-002 NABUMETONE 750MG TABLET / ORAL AB 2011-06-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091083-001 NABUMETONE 500MG TABLET / ORAL AB 2011-06-13 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091083-002 NABUMETONE 750MG TABLET / ORAL AB 2011-06-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091083-001 NABUMETONE 500MG TABLET / ORAL AB 2011-06-13 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091083-002 NABUMETONE 750MG TABLET / ORAL AB 2011-06-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091083-001 NABUMETONE 500MG TABLET / ORAL AB 2011-06-13 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A091083-002 NABUMETONE 750MG TABLET / ORAL AB 2011-06-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091083-001 NABUMETONE 500MG TABLET / ORAL AB 2011-06-13 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091083-002 NABUMETONE 750MG TABLET / ORAL AB 2011-06-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A091083-001 NABUMETONE 500MG TABLET / ORAL AB 2011-06-13 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A091083-002 NABUMETONE 750MG TABLET / ORAL AB 2011-06-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A091083-001 NABUMETONE 500MG TABLET / ORAL AB 2011-06-13 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A091083-002 NABUMETONE 750MG TABLET / ORAL AB 2011-06-13 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A091083-001 NABUMETONE 500MG TABLET / ORAL AB 2011-06-13 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A091083-002 NABUMETONE 750MG TABLET / ORAL AB 2011-06-13 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A091083-001 NABUMETONE 500MG TABLET / ORAL AB 2011-06-13 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A091083-002 NABUMETONE 750MG TABLET / ORAL AB 2011-06-13 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 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 311892 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# NDC, Effective, Related label table NDC Effective Related label 71335-1234-1 2025-09-18 Nabumetone Tablets, USP Rx only 71335-1234-2 2025-09-18 Nabumetone Tablets, USP Rx only 71335-1234-3 2025-09-18 Nabumetone Tablets, USP Rx only 71335-1234-4 2025-09-18 Nabumetone Tablets, USP Rx only 71335-1234-5 2025-09-18 Nabumetone Tablets, USP Rx only 71335-1234-6 2025-09-18 Nabumetone Tablets, USP Rx only 71335-1234-7 2025-09-18 Nabumetone Tablets, USP Rx only 71335-1234-8 2025-09-18 Nabumetone Tablets, USP Rx only 71335-1234-9 2025-09-18 Nabumetone Tablets, USP Rx only 71335-1234-1 2024-01-30 Nabumetone Tablets, USP Rx only 71335-1234-2 2024-01-30 Nabumetone Tablets, USP Rx only 71335-1234-3 2024-01-30 Nabumetone Tablets, USP Rx only 71335-1234-4 2024-01-30 Nabumetone Tablets, USP Rx only 71335-1234-5 2024-01-30 Nabumetone Tablets, USP Rx only 71335-1234-6 2024-01-30 Nabumetone Tablets, USP Rx only 71335-1234-7 2024-01-30 Nabumetone Tablets, USP Rx only 71335-1234-8 2024-01-30 Nabumetone Tablets, USP Rx only 71335-1234-9 2024-01-30 Nabumetone Tablets, USP Rx only
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 71335-1234-1 Nabumetone 20 in 1 BOTTLE TABLET, FILM COATED 20 5 71335-1234-2 Nabumetone 30 in 1 BOTTLE TABLET, FILM COATED 30 5 71335-1234-3 Nabumetone 60 in 1 BOTTLE TABLET, FILM COATED 60 5 71335-1234-4 Nabumetone 90 in 1 BOTTLE TABLET, FILM COATED 90 5 71335-1234-5 Nabumetone 42 in 1 BOTTLE TABLET, FILM COATED 42 5 71335-1234-6 Nabumetone 56 in 1 BOTTLE TABLET, FILM COATED 56 5 71335-1234-7 Nabumetone 14 in 1 BOTTLE TABLET, FILM COATED 14 5 71335-1234-8 Nabumetone 100 in 1 BOTTLE TABLET, FILM COATED 100 5 71335-1234-9 Nabumetone 9 in 1 BOTTLE TABLET, FILM COATED 9 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71335-1234 NABUMETONE TABLET, FILM COATED [BRYANT RANCH PREPACK] 4 Current NDC, Legacy NDC, 9 package rows 20220513_dd0d2652-d335-45db-af43-5a2523f7299a.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 · 5 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Nabumetone NABUMETONE Bryant Ranch Prepack 0186328f-3eb7-4407-bf9e-8007d08ebe7b 2025-09-23 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 091083 application number: ANDA091083 Nabumetone NABUMETONE Bryant Ranch Prepack dd0d2652-d335-45db-af43-5a2523f7299a 2025-09-18 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 091083 application number: ANDA091083 ndc (product): 71335-1234 Nabumetone NABUMETONE Actavis Pharma, Inc. 53656d70-6572-4669-6465-6c6973555341 2025-07-07 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 091083 application number: ANDA091083 Nabumetone NABUMETONE Proficient Rx LP 0870c3c9-bfce-4722-8779-8775644196d3 2022-12-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 091083 application number: ANDA091083 Nabumetone NABUMETONE Proficient Rx LP 079a8a9e-6d71-414a-83f3-ef68e323c1fd 2020-01-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 091083 application number: ANDA091083
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 71335-1234-1 71335123401 20 TABLET, FILM COATED in 1 BOTTLE (71335-1234-1) 2019-05-29 0000-00-00 No No Current 71335-1234-2 71335123402 30 TABLET, FILM COATED in 1 BOTTLE (71335-1234-2) 2019-10-22 0000-00-00 No No Current 71335-1234-3 71335123403 60 TABLET, FILM COATED in 1 BOTTLE (71335-1234-3) 2019-07-03 0000-00-00 No No Current 71335-1234-4 71335123404 90 TABLET, FILM COATED in 1 BOTTLE (71335-1234-4) 2019-06-19 0000-00-00 No No Current 71335-1234-5 71335123405 42 TABLET, FILM COATED in 1 BOTTLE (71335-1234-5) 2022-05-02 0000-00-00 No No Current 71335-1234-6 71335123406 56 TABLET, FILM COATED in 1 BOTTLE (71335-1234-6) 2019-07-15 0000-00-00 No No Current 71335-1234-7 71335123407 14 TABLET, FILM COATED in 1 BOTTLE (71335-1234-7) 2022-05-02 0000-00-00 No No Current 71335-1234-8 71335123408 100 TABLET, FILM COATED in 1 BOTTLE (71335-1234-8) 2022-05-02 0000-00-00 No No Current 71335-1234-9 71335123409 9 TABLET, FILM COATED in 1 BOTTLE (71335-1234-9) 2022-05-02 0000-00-00 No No Current