Home NDC 61919-159 NABUMETONE
Product NDC 61919-159
11-digit product format 619190159
Labeler code 61919
Product ID 61919-159_9ca996d4-3b69-05db-e053-2995a90a9b81
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name NABUMETONE
Dosage form TABLET, FILM COATED
Route ORAL
Labeler DIRECT RX
Application ANDA075189
Marketing category ANDA
Marketing start 2016-03-03
Marketing end 0000-00-00
Substance NABUMETONE
Active strength 500 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 2021-12-31
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 2 · 102 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 A075189-001 NABUMETONE NABUMETONE 500MG TABLET / ORAL 2000-05-26 A075189-002 NABUMETONE NABUMETONE 750MG TABLET / ORAL 2001-09-24
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 A075189-001 NABUMETONE 500MG TABLET / ORAL 2000-05-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075189-002 NABUMETONE 750MG TABLET / ORAL 2001-09-24 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075189-001 NABUMETONE 500MG TABLET / ORAL 2000-05-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075189-002 NABUMETONE 750MG TABLET / ORAL 2001-09-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075189-001 NABUMETONE 500MG TABLET / ORAL 2000-05-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075189-002 NABUMETONE 750MG TABLET / ORAL 2001-09-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075189-001 NABUMETONE 500MG TABLET / ORAL 2000-05-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075189-002 NABUMETONE 750MG TABLET / ORAL 2001-09-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075189-001 NABUMETONE 500MG TABLET / ORAL 2000-05-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075189-002 NABUMETONE 750MG TABLET / ORAL 2001-09-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075189-001 NABUMETONE 500MG TABLET / ORAL 2000-05-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075189-002 NABUMETONE 750MG TABLET / ORAL 2001-09-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075189-001 NABUMETONE 500MG TABLET / ORAL 2000-05-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075189-002 NABUMETONE 750MG TABLET / ORAL 2001-09-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075189-001 NABUMETONE 500MG TABLET / ORAL 2000-05-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075189-002 NABUMETONE 750MG TABLET / ORAL 2001-09-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075189-001 NABUMETONE 500MG TABLET / ORAL 2000-05-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075189-002 NABUMETONE 750MG TABLET / ORAL 2001-09-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075189-001 NABUMETONE 500MG TABLET / ORAL 2000-05-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075189-002 NABUMETONE 750MG TABLET / ORAL 2001-09-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075189-001 NABUMETONE 500MG TABLET / ORAL 2000-05-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075189-002 NABUMETONE 750MG TABLET / ORAL 2001-09-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075189-001 NABUMETONE 500MG TABLET / ORAL 2000-05-26 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075189-002 NABUMETONE 750MG TABLET / ORAL 2001-09-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075189-001 NABUMETONE 500MG TABLET / ORAL 2000-05-26 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075189-002 NABUMETONE 750MG TABLET / ORAL 2001-09-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075189-001 NABUMETONE 500MG TABLET / ORAL 2000-05-26 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075189-002 NABUMETONE 750MG TABLET / ORAL 2001-09-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075189-001 NABUMETONE 500MG TABLET / ORAL 2000-05-26 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A075189-002 NABUMETONE 750MG TABLET / ORAL 2001-09-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075189-001 NABUMETONE 500MG TABLET / ORAL 2000-05-26 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075189-002 NABUMETONE 750MG TABLET / ORAL 2001-09-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075189-001 NABUMETONE 500MG TABLET / ORAL 2000-05-26 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A075189-002 NABUMETONE 750MG TABLET / ORAL 2001-09-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075189-001 NABUMETONE 500MG TABLET / ORAL 2000-05-26 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A075189-002 NABUMETONE 750MG TABLET / ORAL 2001-09-24 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075189-001 NABUMETONE 500MG TABLET / ORAL AB 2000-05-26 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A075189-002 NABUMETONE 750MG TABLET / ORAL AB RS 2001-09-24 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075189-001 NABUMETONE 500MG TABLET / ORAL 2000-05-26 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A075189-002 NABUMETONE 750MG TABLET / ORAL 2001-09-24 bb7c543d1eb4…
Observed Orange Book normalized TE history# 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 61919-159-90 NABUMETONE 90 in 1 BOTTLE TABLET, FILM COATED 90 3 61919-159-30 NABUMETONE 30 in 1 BOTTLE TABLET, FILM COATED 30 2 61919-159-60 NABUMETONE 60 in 1 BOTTLE TABLET, FILM COATED 60 2
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded NABUMETONE ACTIVE INGREDIENT LW0TIW155Z NABUMETONE TABLET, FILM COATED [DIRECT RX] 2 NABUMETONE ACTIVE MOIETY LW0TIW155Z NABUMETONE TABLET, FILM COATED [DIRECT RX] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U NABUMETONE TABLET, FILM COATED [DIRECT RX] 2 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 NABUMETONE TABLET, FILM COATED [DIRECT RX] 2 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT NABUMETONE TABLET, FILM COATED [DIRECT RX] 2 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 NABUMETONE TABLET, FILM COATED [DIRECT RX] 2 HYPROMELLOSE 2910 (3 MPA.S) INACTIVE INGREDIENT 0VUT3PMY82 NABUMETONE TABLET, FILM COATED [DIRECT RX] 2 HYPROMELLOSE 2910 (5 MPA.S) INACTIVE INGREDIENT R75537T0T4 NABUMETONE TABLET, FILM COATED [DIRECT RX] 2 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ NABUMETONE TABLET, FILM COATED [DIRECT RX] 2 POLYETHYLENE GLYCOL 6000 INACTIVE INGREDIENT 30IQX730WE NABUMETONE TABLET, FILM COATED [DIRECT RX] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 NABUMETONE TABLET, FILM COATED [DIRECT RX] 2 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J NABUMETONE TABLET, FILM COATED [DIRECT RX] 2 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 NABUMETONE TABLET, FILM COATED [DIRECT RX] 2 TALC INACTIVE INGREDIENT 7SEV7J4R1U NABUMETONE TABLET, FILM COATED [DIRECT RX] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP NABUMETONE TABLET, FILM COATED [DIRECT RX] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61919-159 NABUMETONE TABLET, FILM COATED [DIRECT RX] 3 Legacy NDC, 1 package rows 20200131_2d8f206e-0853-43ca-e054-00144ff8d46c.zip 61919-159 NABUMETONE TABLET, FILM COATED [DIRECT RX] 2 Legacy NDC, 2 package rows 20150829_3cbe54ab-137b-4a1d-8490-d9e826cccbfc.zip
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 61919-159-30 61919015930 30 in 1 BOTTLE Historical 61919-159-60 61919015960 60 in 1 BOTTLE Historical 61919-159-90 61919015990 90 TABLET, FILM COATED in 1 BOTTLE (61919-159-90) 2016-03-03 0000-00-00 No No Current