Nabumetone
- Product NDC
- 50228-466
- Requested package NDC
- 50228-466-05
- 11-digit product format
- 502280466
- Labeler code
- 50228
- Product ID
- 50228-466_2b9b03ef-e03c-eca1-e063-6394a90a3fad
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nabumetone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- ScieGen Pharmaceuticals Inc
- Application
- ANDA078420
- Marketing category
- ANDA
- Marketing start
- 2019-06-26
- 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
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A078420-001 | NABUMETONE | NABUMETONE | 500MG | TABLET / ORAL | AB | 2008-09-24 | |
| A078420-002 | NABUMETONE | NABUMETONE | 750MG | TABLET / ORAL | AB | 2008-09-24 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A078420-001 | AB |
| A078420-002 | AB |
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.
| 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 | A078420-001 | NABUMETONE | 500MG | TABLET / ORAL | AB | 2008-09-24 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078420-002 | NABUMETONE | 750MG | TABLET / ORAL | AB | 2008-09-24 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078420-001 | NABUMETONE | 500MG | TABLET / ORAL | AB | 2008-09-24 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078420-002 | NABUMETONE | 750MG | TABLET / ORAL | AB | 2008-09-24 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078420-001 | NABUMETONE | 500MG | TABLET / ORAL | AB | 2008-09-24 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078420-002 | NABUMETONE | 750MG | TABLET / ORAL | AB | 2008-09-24 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078420-001 | NABUMETONE | 500MG | TABLET / ORAL | AB | 2008-09-24 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078420-002 | NABUMETONE | 750MG | TABLET / ORAL | AB | 2008-09-24 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078420-001 | NABUMETONE | 500MG | TABLET / ORAL | AB | 2008-09-24 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078420-002 | NABUMETONE | 750MG | TABLET / ORAL | AB | 2008-09-24 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078420-001 | NABUMETONE | 500MG | TABLET / ORAL | AB | 2008-09-24 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078420-002 | NABUMETONE | 750MG | TABLET / ORAL | AB | 2008-09-24 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078420-001 | NABUMETONE | 500MG | TABLET / ORAL | AB | 2008-09-24 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078420-002 | NABUMETONE | 750MG | TABLET / ORAL | AB | 2008-09-24 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078420-001 | NABUMETONE | 500MG | TABLET / ORAL | AB | 2008-09-24 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078420-002 | NABUMETONE | 750MG | TABLET / ORAL | AB | 2008-09-24 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078420-001 | NABUMETONE | 500MG | TABLET / ORAL | AB | 2008-09-24 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078420-002 | NABUMETONE | 750MG | TABLET / ORAL | AB | 2008-09-24 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078420-001 | NABUMETONE | 500MG | TABLET / ORAL | AB | 2008-09-24 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078420-002 | NABUMETONE | 750MG | TABLET / ORAL | AB | 2008-09-24 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078420-001 | NABUMETONE | 500MG | TABLET / ORAL | AB | 2008-09-24 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078420-002 | NABUMETONE | 750MG | TABLET / ORAL | AB | 2008-09-24 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078420-001 | NABUMETONE | 500MG | TABLET / ORAL | AB | 2008-09-24 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078420-002 | NABUMETONE | 750MG | TABLET / ORAL | AB | 2008-09-24 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078420-001 | NABUMETONE | 500MG | TABLET / ORAL | AB | 2008-09-24 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078420-002 | NABUMETONE | 750MG | TABLET / ORAL | AB | 2008-09-24 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A078420-001 | NABUMETONE | 500MG | TABLET / ORAL | AB | 2008-09-24 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A078420-002 | NABUMETONE | 750MG | TABLET / ORAL | AB | 2008-09-24 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A078420-001 | NABUMETONE | 500MG | TABLET / ORAL | AB | 2008-09-24 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A078420-002 | NABUMETONE | 750MG | TABLET / ORAL | AB | 2008-09-24 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A078420-001 | NABUMETONE | 500MG | TABLET / ORAL | AB | 2008-09-24 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A078420-002 | NABUMETONE | 750MG | TABLET / ORAL | AB | 2008-09-24 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A078420-001 | NABUMETONE | 500MG | TABLET / ORAL | AB | 2008-09-24 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A078420-002 | NABUMETONE | 750MG | TABLET / ORAL | AB | 2008-09-24 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A078420-001 | NABUMETONE | 500MG | TABLET / ORAL | AB | 2008-09-24 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A078420-002 | NABUMETONE | 750MG | TABLET / ORAL | AB | 2008-09-24 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A078420-001 | NABUMETONE | 500MG | TABLET / ORAL | AB | 2008-09-24 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A078420-002 | NABUMETONE | 750MG | TABLET / ORAL | AB | 2008-09-24 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A078420-001 | NABUMETONE | 500MG | TABLET / ORAL | AB | 2008-09-24 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | A078420-002 | NABUMETONE | 750MG | TABLET / ORAL | AB | 2008-09-24 | 782e0a99824c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A078420-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078420-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078420-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078420-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A078420-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078420-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078420-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078420-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078420-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078420-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078420-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078420-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078420-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078420-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078420-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078420-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078420-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078420-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A078420-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078420-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078420-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078420-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078420-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078420-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078420-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078420-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A078420-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A078420-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A078420-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A078420-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A078420-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A078420-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A078420-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A078420-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A078420-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A078420-002 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A078420-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A078420-002 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A078420-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A078420-002 | AB | 1 | 782e0a99824c… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Nabumetone
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| NABUMETONE | 750 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| LW0TIW155Z | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 80c6888d-03b4-44f3-b94d-bcf5154ceae5 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 9d4d18c4-d38e-37e1-df1c-ee38762bf8a5 | Product name | 4 | 20251024 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50228-466-01 | Nabumetone | 100 in 1 BOTTLE | TABLET | 100 | 6 | |
| 50228-466-05 | Nabumetone | 500 in 1 BOTTLE | TABLET | 500 | 6 | |
| 50228-466-30 | Nabumetone | 30 in 1 BOTTLE | TABLET | 30 | 6 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50228-466-01 | EA - Each | 50228-466 | f59a501c-e15e-4ee5-bd96-9c123fcd5422 | 1 | 2019-08-06 |
| 50228-466-05 | EA - Each | 50228-466 | 6d2de5e3-8213-44fb-8d09-29d4a015e380 | 1 | 2019-08-06 |
DailyMed Dashboard NDC Coverage#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Nabumetone | NABUMETONE | Preferred Pharmaceuticals, Inc. | 95769e02-fa4a-4389-a2fa-3146eae02526 | 2026-07-28 | Boxed warning, Warnings, Adverse reactions | 078420 ANDA078420 |
| Nabumetone | NABUMETONE | Preferred Pharmaceuticals Inc. | 455c9992-39a0-4353-a121-57e700c77942 | 2026-07-28 | Boxed warning, Warnings, Adverse reactions | 078420 ANDA078420 |
| Nabumetone | NABUMETONE | St. Mary's Medical Park Pharmacy | 95aa8124-08fe-ff2f-e053-2a95a90a3c8f | 2026-06-25 | Boxed warning, Warnings, Adverse reactions | 078420 ANDA078420 |
| Nabumetone | NABUMETONE | REMEDYREPACK INC. | 311ae656-55d2-4116-a1bd-6f4a4ce70185 | 2026-06-09 | Boxed warning, Warnings, Adverse reactions | 078420 ANDA078420 |
| Nabumetone | NABUMETONE | St. Mary's Medical Park Pharmacy | 94930125-b792-579e-e053-2995a90ab6f9 | 2026-05-15 | Boxed warning, Warnings, Adverse reactions | 078420 ANDA078420 |
| Nabumetone | NABUMETONE | REMEDYREPACK INC. | 6106afa3-e138-4b4d-8c13-992bf5062097 | 2026-02-23 | Boxed warning, Warnings, Adverse reactions | 078420 ANDA078420 |
| Nabumetone | NABUMETONE | Northwind Health Company, LLC | d9ca2484-7293-7db6-e053-2995a90a0f13 | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | 078420 ANDA078420 |
| Nabumetone | NABUMETONE | Northwind Health Company, LLC | da34003b-81a4-2efd-e053-2995a90a961c | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | 078420 ANDA078420 |
| Nabumetone | NABUMETONE | Redpharm Drug | 3745775e-e11a-01db-e063-6294a90a9b52 | 2025-12-24 | Boxed warning, Warnings, Adverse reactions | 078420 ANDA078420 |
| Nabumetone | NABUMETONE | PD-Rx Pharmaceuticals, Inc. | 75c51686-9c5e-4c13-acf4-2d04502eedda | 2025-12-24 | Boxed warning, Warnings, Adverse reactions | 078420 ANDA078420 |
| Nabumetone | NABUMETONE | Bryant Ranch Prepack | 583602ff-dbbe-4369-afa9-b917734ac9b1 | 2025-04-01 | Boxed warning, Warnings, Adverse reactions | 078420 ANDA078420 |
| Nabumetone | NABUMETONE | Bryant Ranch Prepack | b2a41c0b-e2ad-4e14-a2f7-2049c12c35da | 2025-03-31 | Boxed warning, Warnings, Adverse reactions | 078420 ANDA078420 |
| Nabumetone | NABUMETONE | Bryant Ranch Prepack | ad9f2a34-6244-49b7-98ee-af18cb55693c | 2025-03-31 | Boxed warning, Warnings, Adverse reactions | 078420 ANDA078420 |
| Nabumetone | NABUMETONE | Bryant Ranch Prepack | 06f73fa8-7a8f-4160-939e-a25980a11906 | 2025-03-31 | Boxed warning, Warnings, Adverse reactions | 078420 ANDA078420 |
| Nabumetone | NABUMETONE | Bryant Ranch Prepack | 5a66c21f-4f06-4fb8-98fa-e81949586afd | 2025-03-31 | Boxed warning, Warnings, Adverse reactions | 078420 ANDA078420 |
| Nabumetone | NABUMETONE | Bryant Ranch Prepack | 419c597f-6a6f-4420-b240-7dc4c223387e | 2025-03-27 | Boxed warning, Warnings, Adverse reactions | 078420 ANDA078420 |
| Nabumetone | NABUMETONE | Bryant Ranch Prepack | a4553637-498e-491a-982a-cff81b43aa6c | 2025-03-27 | Boxed warning, Warnings, Adverse reactions | 078420 ANDA078420 |
| Nabumetone | NABUMETONE | Bryant Ranch Prepack | 5ba602e9-846e-42b3-9ea6-fb461a948947 | 2025-03-26 | Boxed warning, Warnings, Adverse reactions | 078420 ANDA078420 |
| Nabumetone | NABUMETONE | Bryant Ranch Prepack | 0be7ee60-2706-43ed-98ec-b89cd4e2b57c | 2025-03-26 | Boxed warning, Warnings, Adverse reactions | 078420 ANDA078420 |
| Nabumetone | NABUMETONE | PD-Rx Pharmaceuticals, Inc. | 69620c53-b37a-45b9-b560-221bbcd98fda | 2025-02-04 | Boxed warning, Warnings, Adverse reactions | 078420 ANDA078420 |
DailyMed RxNorm Mappings#
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 50228-466-05 | 50228046605 | 500 TABLET in 1 BOTTLE (50228-466-05) | 500 tablet | 2019-06-26 | 0000-00-00 | No | No | Current |