Bumetanide
- Product NDC
- 43353-292
- Requested package NDC
- 43353-292-51
- 11-digit product format
- 433530292
- Labeler code
- 43353
- Product ID
- 43353-292_b3048e2b-3ff7-4160-870f-147d792ec36c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Bumetanide
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA074700
- Marketing category
- ANDA
- Marketing start
- 1996-11-21
- Marketing end
- 0000-00-00
- Substance
- BUMETANIDE
- Active strength
- 2 mg/1
- Pharmacologic classes
- Loop Diuretic [EPC],Increased Diuresis at Loop of Henle [PE]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 43353-292 | 43353-292-51 | D | Discontinued by firm | 2026-08-07 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A074700-001 | BUMETANIDE | BUMETANIDE | 0.5MG | TABLET / ORAL | AB | 1996-11-21 | |
| A074700-002 | BUMETANIDE | BUMETANIDE | 1MG | TABLET / ORAL | AB | 1996-11-21 | |
| A074700-003 | BUMETANIDE | BUMETANIDE | 2MG | TABLET / ORAL | AB | RS | 1996-11-21 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A074700-001 | AB |
| A074700-002 | AB |
| A074700-003 | 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 | A074700-001 | BUMETANIDE | 0.5MG | TABLET / ORAL | AB | 1996-11-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A074700-002 | BUMETANIDE | 1MG | TABLET / ORAL | AB | 1996-11-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A074700-003 | BUMETANIDE | 2MG | TABLET / ORAL | AB | RS | 1996-11-21 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A074700-001 | BUMETANIDE | 0.5MG | TABLET / ORAL | AB | 1996-11-21 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A074700-002 | BUMETANIDE | 1MG | TABLET / ORAL | AB | 1996-11-21 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A074700-003 | BUMETANIDE | 2MG | TABLET / ORAL | AB | RS | 1996-11-21 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A074700-001 | BUMETANIDE | 0.5MG | TABLET / ORAL | AB | 1996-11-21 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A074700-002 | BUMETANIDE | 1MG | TABLET / ORAL | AB | 1996-11-21 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A074700-003 | BUMETANIDE | 2MG | TABLET / ORAL | AB | RS | 1996-11-21 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A074700-001 | BUMETANIDE | 0.5MG | TABLET / ORAL | AB | 1996-11-21 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A074700-002 | BUMETANIDE | 1MG | TABLET / ORAL | AB | 1996-11-21 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A074700-003 | BUMETANIDE | 2MG | TABLET / ORAL | AB | RS | 1996-11-21 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A074700-001 | BUMETANIDE | 0.5MG | TABLET / ORAL | AB | 1996-11-21 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A074700-002 | BUMETANIDE | 1MG | TABLET / ORAL | AB | 1996-11-21 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A074700-003 | BUMETANIDE | 2MG | TABLET / ORAL | AB | RS | 1996-11-21 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A074700-001 | BUMETANIDE | 0.5MG | TABLET / ORAL | AB | 1996-11-21 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A074700-002 | BUMETANIDE | 1MG | TABLET / ORAL | AB | 1996-11-21 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A074700-003 | BUMETANIDE | 2MG | TABLET / ORAL | AB | RS | 1996-11-21 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A074700-001 | BUMETANIDE | 0.5MG | TABLET / ORAL | AB | 1996-11-21 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A074700-002 | BUMETANIDE | 1MG | TABLET / ORAL | AB | 1996-11-21 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A074700-003 | BUMETANIDE | 2MG | TABLET / ORAL | AB | RS | 1996-11-21 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A074700-001 | BUMETANIDE | 0.5MG | TABLET / ORAL | AB | 1996-11-21 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A074700-002 | BUMETANIDE | 1MG | TABLET / ORAL | AB | 1996-11-21 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A074700-003 | BUMETANIDE | 2MG | TABLET / ORAL | AB | RS | 1996-11-21 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A074700-001 | BUMETANIDE | 0.5MG | TABLET / ORAL | AB | 1996-11-21 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A074700-002 | BUMETANIDE | 1MG | TABLET / ORAL | AB | 1996-11-21 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A074700-003 | BUMETANIDE | 2MG | TABLET / ORAL | AB | RS | 1996-11-21 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A074700-001 | BUMETANIDE | 0.5MG | TABLET / ORAL | AB | 1996-11-21 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A074700-002 | BUMETANIDE | 1MG | TABLET / ORAL | AB | 1996-11-21 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A074700-003 | BUMETANIDE | 2MG | TABLET / ORAL | AB | RS | 1996-11-21 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A074700-001 | BUMETANIDE | 0.5MG | TABLET / ORAL | AB | 1996-11-21 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A074700-002 | BUMETANIDE | 1MG | TABLET / ORAL | AB | 1996-11-21 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A074700-003 | BUMETANIDE | 2MG | TABLET / ORAL | AB | RS | 1996-11-21 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A074700-001 | BUMETANIDE | 0.5MG | TABLET / ORAL | AB | 1996-11-21 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A074700-002 | BUMETANIDE | 1MG | TABLET / ORAL | AB | 1996-11-21 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A074700-003 | BUMETANIDE | 2MG | TABLET / ORAL | AB | RS | 1996-11-21 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A074700-001 | BUMETANIDE | 0.5MG | TABLET / ORAL | AB | 1996-11-21 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A074700-002 | BUMETANIDE | 1MG | TABLET / ORAL | AB | 1996-11-21 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A074700-003 | BUMETANIDE | 2MG | TABLET / ORAL | AB | RS | 1996-11-21 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A074700-001 | BUMETANIDE | 0.5MG | TABLET / ORAL | AB | 1996-11-21 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A074700-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A074700-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A074700-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A074700-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A074700-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A074700-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A074700-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A074700-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A074700-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A074700-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A074700-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A074700-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A074700-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A074700-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A074700-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A074700-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A074700-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A074700-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A074700-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A074700-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A074700-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A074700-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A074700-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A074700-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A074700-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A074700-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A074700-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A074700-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A074700-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A074700-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A074700-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A074700-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A074700-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A074700-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A074700-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A074700-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A074700-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A074700-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A074700-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A074700-001 | AB | 1 | 8072bd15b7f6… |
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 |
|---|---|---|---|---|---|---|
| Bumetanide | BUMETANIDE | Sandoz Inc | 8914d8bf-61b7-4cd2-a8ef-7e1c5df37828 | 2026-06-03 | Boxed warning, Warnings, Adverse reactions | 074700 ANDA074700 |
| Bumetanide | BUMETANIDE | Bryant Ranch Prepack | 12b9489a-b16b-4504-a660-e66fd5261069 | 2025-11-04 | Boxed warning, Warnings, Adverse reactions | 074700 ANDA074700 |
| Bumetanide | BUMETANIDE | Bryant Ranch Prepack | b2dcdf9b-70b9-493f-99b4-fc7dcc31939a | 2025-10-21 | Boxed warning, Warnings, Adverse reactions | 074700 ANDA074700 |
| Bumetanide | BUMETANIDE | Bryant Ranch Prepack | 6b5450f2-ae91-48b6-ad83-261bdfcf47ac | 2025-07-28 | Boxed warning, Warnings, Adverse reactions | 074700 ANDA074700 |
| Bumetanide | BUMETANIDE | REMEDYREPACK INC. | 0fb78afc-d8bc-4ae8-8c0a-6d9c6f7a22c5 | 2025-07-07 | Boxed warning, Warnings, Adverse reactions | 074700 ANDA074700 |
| Bumetanide | BUMETANIDE | Bryant Ranch Prepack | a7068f36-a863-4af0-9c82-e5394a6e7a54 | 2025-06-26 | Boxed warning, Warnings, Adverse reactions | 074700 ANDA074700 |
| Bumetanide | BUMETANIDE | Bryant Ranch Prepack | 056be255-5880-48e9-b160-bd5b3d82c24a | 2025-01-08 | Boxed warning, Warnings, Adverse reactions | 074700 ANDA074700 |
| Bumetanide | BUMETANIDE | Bryant Ranch Prepack | 80fe034e-01b7-438e-8378-44fafb7a1d94 | 2025-01-08 | Boxed warning, Warnings, Adverse reactions | 074700 ANDA074700 |
| Bumetanide | BUMETANIDE | Bryant Ranch Prepack | 0fb6d547-9966-4352-8974-d02ea58e6445 | 2024-07-24 | Boxed warning, Warnings, Adverse reactions | 074700 ANDA074700 |
| Bumetanide | BUMETANIDE | Proficient Rx LP | 6e3d3ea1-830f-4fc6-9c56-b2ec71875dc6 | 2024-07-01 | Boxed warning, Warnings, Adverse reactions | 074700 ANDA074700 |
| Bumetanide | BUMETANIDE | Bryant Ranch Prepack | f6f12a41-ae6d-4ce6-9bb1-e32679af665f | 2024-01-26 | Boxed warning, Warnings, Adverse reactions | 074700 ANDA074700 |
| Bumetanide | BUMETANIDE | Sandoz Inc | 05cb961d-ac33-4bcf-b04e-411e496c43c1 | 2023-06-30 | Boxed warning, Warnings, Adverse reactions | 074700 ANDA074700 |
| Bumetanide | BUMETANIDE | A-S Medication Solutions | 7f9dccf8-37ff-454b-9d55-7f1d631c8483 | 2023-01-25 | Boxed warning, Warnings, Adverse reactions | 074700 ANDA074700 |
| Bumetanide | BUMETANIDE | A-S Medication Solutions | f6ff0d37-c67d-4b9f-8b62-5deda9783c28 | 2023-01-05 | Boxed warning, Warnings, Adverse reactions | 074700 ANDA074700 |
| Bumetanide | BUMETANIDE | A-S Medication Solutions | 8bed63fb-91ec-4132-ac0a-16c4c6f58d95 | 2023-01-03 | Boxed warning, Warnings, Adverse reactions | 074700 ANDA074700 |
| Bumetanide | BUMETANIDE | Aphena Pharma Solutions - Tennessee, LLC | 7e47e7b1-d28a-4e12-882f-cf193b7f2697 | 2019-09-30 | Boxed warning, Warnings, Adverse reactions | 074700 ANDA074700 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 43353-292-51 | 43353029251 | 6000 TABLET in 1 BOTTLE (43353-292-51) | 6000 tablet | 2017-03-10 | 0000-00-00 | No | No | Current |