Home NDC 10544-273 Nabumetone
Product NDC 10544-273
11-digit product format 105440273
Labeler code 10544
Product ID 10544-273_c54513d2-ddbd-4ace-a48b-a4fd2d8f6bec
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Nabumetone
Dosage form TABLET
Route ORAL
Labeler Blenheim Pharmacal, Inc.
Application ANDA076009
Marketing category ANDA
Marketing start 2010-03-24
Marketing end 0000-00-00
Substance NABUMETONE
Active strength 500 mg/1
Pharmacologic classes Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag E
Listing certified through 2017-12-31
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 · 110 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 A076009-001 NABUMETONE NABUMETONE 500MG TABLET / ORAL AB 2003-01-24 A076009-002 NABUMETONE NABUMETONE 750MG TABLET / ORAL AB 2003-01-24
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 · 88 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 2026-10-15 13:18:30 2026-09 A076009-001 NABUMETONE 500MG TABLET / ORAL AB 2003-01-24 c2088c7a36db…2026-10-15 13:18:30 2026-09 A076009-002 NABUMETONE 750MG TABLET / ORAL AB 2003-01-24 c2088c7a36db…2026-09-14 22:38:34 2026-08 A076009-001 NABUMETONE 500MG TABLET / ORAL AB 2003-01-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076009-002 NABUMETONE 750MG TABLET / ORAL AB 2003-01-24 84e616aacf4f…2026-08-18 06:07:40 2026-07 A076009-001 NABUMETONE 500MG TABLET / ORAL AB 2003-01-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076009-002 NABUMETONE 750MG TABLET / ORAL AB 2003-01-24 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076009-001 NABUMETONE 500MG TABLET / ORAL AB 2003-01-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076009-002 NABUMETONE 750MG TABLET / ORAL AB 2003-01-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076009-001 NABUMETONE 500MG TABLET / ORAL AB 2003-01-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076009-002 NABUMETONE 750MG TABLET / ORAL AB 2003-01-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076009-001 NABUMETONE 500MG TABLET / ORAL AB 2003-01-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076009-002 NABUMETONE 750MG TABLET / ORAL AB 2003-01-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076009-001 NABUMETONE 500MG TABLET / ORAL AB 2003-01-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076009-002 NABUMETONE 750MG TABLET / ORAL AB 2003-01-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076009-001 NABUMETONE 500MG TABLET / ORAL AB 2003-01-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076009-002 NABUMETONE 750MG TABLET / ORAL AB 2003-01-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076009-001 NABUMETONE 500MG TABLET / ORAL AB 2003-01-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076009-002 NABUMETONE 750MG TABLET / ORAL AB 2003-01-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076009-001 NABUMETONE 500MG TABLET / ORAL AB 2003-01-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076009-002 NABUMETONE 750MG TABLET / ORAL AB 2003-01-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076009-001 NABUMETONE 500MG TABLET / ORAL AB 2003-01-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076009-002 NABUMETONE 750MG TABLET / ORAL AB 2003-01-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076009-001 NABUMETONE 500MG TABLET / ORAL AB 2003-01-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076009-002 NABUMETONE 750MG TABLET / ORAL AB 2003-01-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076009-001 NABUMETONE 500MG TABLET / ORAL AB 2003-01-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076009-002 NABUMETONE 750MG TABLET / ORAL AB 2003-01-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076009-001 NABUMETONE 500MG TABLET / ORAL AB 2003-01-24 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076009-002 NABUMETONE 750MG TABLET / ORAL AB 2003-01-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076009-001 NABUMETONE 500MG TABLET / ORAL AB 2003-01-24 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076009-002 NABUMETONE 750MG TABLET / ORAL AB 2003-01-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076009-001 NABUMETONE 500MG TABLET / ORAL AB 2003-01-24 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076009-002 NABUMETONE 750MG TABLET / ORAL AB 2003-01-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076009-001 NABUMETONE 500MG TABLET / ORAL AB 2003-01-24 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A076009-002 NABUMETONE 750MG TABLET / ORAL AB 2003-01-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076009-001 NABUMETONE 500MG TABLET / ORAL AB 2003-01-24 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076009-002 NABUMETONE 750MG TABLET / ORAL AB 2003-01-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076009-001 NABUMETONE 500MG TABLET / ORAL AB 2003-01-24 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A076009-002 NABUMETONE 750MG TABLET / ORAL AB 2003-01-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076009-001 NABUMETONE 500MG TABLET / ORAL AB 2003-01-24 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A076009-002 NABUMETONE 750MG TABLET / ORAL AB 2003-01-24 4b0b4de00fa7…
Observed Orange Book normalized TE history# Normalized TE history page 3 of 3 · 88 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 10544-273-20 Nabumetone 20 in 1 BOTTLE TABLET 20 1 10544-273-30 Nabumetone 30 in 1 BOTTLE TABLET 30 1 10544-273-40 Nabumetone 40 in 1 BOTTLE TABLET 40 1 10544-273-60 Nabumetone 60 in 1 BOTTLE TABLET 60 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded NABUMETONE ACTIVE INGREDIENT LW0TIW155Z NABUMETONE TABLET [BLENHEIM PHARMACAL, INC.] 1 NABUMETONE ACTIVE MOIETY LW0TIW155Z NABUMETONE TABLET [BLENHEIM PHARMACAL, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U NABUMETONE TABLET [BLENHEIM PHARMACAL, INC.] 1 COLLOIDAL SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 NABUMETONE TABLET [BLENHEIM PHARMACAL, INC.] 1 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G NABUMETONE TABLET [BLENHEIM PHARMACAL, INC.] 1 HYPROMELLOSE INACTIVE INGREDIENT 3NXW29V3WO NABUMETONE TABLET [BLENHEIM PHARMACAL, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 NABUMETONE TABLET [BLENHEIM PHARMACAL, INC.] 1 POLYETHYLENE GLYCOL INACTIVE INGREDIENT 3WJQ0SDW1A NABUMETONE TABLET [BLENHEIM PHARMACAL, INC.] 1 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H NABUMETONE TABLET [BLENHEIM PHARMACAL, INC.] 1 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J NABUMETONE TABLET [BLENHEIM PHARMACAL, INC.] 1 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 NABUMETONE TABLET [BLENHEIM PHARMACAL, INC.] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP NABUMETONE TABLET [BLENHEIM PHARMACAL, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 10544-273 NABUMETONE TABLET [BLENHEIM PHARMACAL, INC.] 1 Legacy NDC, 4 package rows 20100422_72400d93-7ec6-494a-8dc0-6de8f6c0c531.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 10544-273-20 10544027320 20 in 1 BOTTLE Historical 10544-273-30 10544027330 30 in 1 BOTTLE Historical 10544-273-40 10544027340 40 in 1 BOTTLE Historical 10544-273-60 10544027360 60 in 1 BOTTLE Historical