Furosemide
- Product NDC
- 0054-4299
- Requested package NDC
- 0054-4299-25
- 11-digit product format
- 000544299
- Labeler code
- 0054
- Product ID
- 0054-4299_bc62ddda-7639-4090-99f0-7dd4d13518f3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Furosemide
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- NDA018823
- Marketing category
- NDA
- Marketing start
- 1983-11-10
- Substance
- FUROSEMIDE
- Active strength
- 40 mg/1
- Pharmacologic classes
- Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N018823-001 | FUROSEMIDE | FUROSEMIDE | 20MG | TABLET / ORAL | AB | 1983-11-10 | |
| N018823-002 | FUROSEMIDE | FUROSEMIDE | 40MG | TABLET / ORAL | AB | 1983-11-10 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N018823-001 | AB |
| N018823-002 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N018823-001 | FUROSEMIDE | 20MG | TABLET / ORAL | AB | 1983-11-10 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N018823-002 | FUROSEMIDE | 40MG | TABLET / ORAL | AB | 1983-11-10 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N018823-001 | FUROSEMIDE | 20MG | TABLET / ORAL | AB | 1983-11-10 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N018823-002 | FUROSEMIDE | 40MG | TABLET / ORAL | AB | 1983-11-10 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N018823-001 | FUROSEMIDE | 20MG | TABLET / ORAL | AB | 1983-11-10 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N018823-002 | FUROSEMIDE | 40MG | TABLET / ORAL | AB | 1983-11-10 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018823-001 | FUROSEMIDE | 20MG | TABLET / ORAL | AB | 1983-11-10 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018823-002 | FUROSEMIDE | 40MG | TABLET / ORAL | AB | 1983-11-10 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N018823-001 | FUROSEMIDE | 20MG | TABLET / ORAL | AB | 1983-11-10 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N018823-002 | FUROSEMIDE | 40MG | TABLET / ORAL | AB | 1983-11-10 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018823-001 | FUROSEMIDE | 20MG | TABLET / ORAL | AB | 1983-11-10 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018823-002 | FUROSEMIDE | 40MG | TABLET / ORAL | AB | 1983-11-10 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018823-001 | FUROSEMIDE | 20MG | TABLET / ORAL | AB | 1983-11-10 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018823-002 | FUROSEMIDE | 40MG | TABLET / ORAL | AB | 1983-11-10 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018823-001 | FUROSEMIDE | 20MG | TABLET / ORAL | AB | 1983-11-10 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018823-002 | FUROSEMIDE | 40MG | TABLET / ORAL | AB | 1983-11-10 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018823-001 | FUROSEMIDE | 20MG | TABLET / ORAL | AB | 1983-11-10 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018823-002 | FUROSEMIDE | 40MG | TABLET / ORAL | AB | 1983-11-10 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018823-001 | FUROSEMIDE | 20MG | TABLET / ORAL | AB | 1983-11-10 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018823-002 | FUROSEMIDE | 40MG | TABLET / ORAL | AB | 1983-11-10 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N018823-001 | FUROSEMIDE | 20MG | TABLET / ORAL | AB | 1983-11-10 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N018823-002 | FUROSEMIDE | 40MG | TABLET / ORAL | AB | 1983-11-10 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N018823-001 | FUROSEMIDE | 20MG | TABLET / ORAL | AB | 1983-11-10 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N018823-002 | FUROSEMIDE | 40MG | TABLET / ORAL | AB | 1983-11-10 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N018823-001 | FUROSEMIDE | 20MG | TABLET / ORAL | AB | 1983-11-10 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N018823-002 | FUROSEMIDE | 40MG | TABLET / ORAL | AB | 1983-11-10 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N018823-001 | FUROSEMIDE | 20MG | TABLET / ORAL | AB | 1983-11-10 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N018823-002 | FUROSEMIDE | 40MG | TABLET / ORAL | AB | 1983-11-10 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N018823-001 | FUROSEMIDE | 20MG | TABLET / ORAL | AB | 1983-11-10 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N018823-002 | FUROSEMIDE | 40MG | TABLET / ORAL | AB | 1983-11-10 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N018823-001 | FUROSEMIDE | 20MG | TABLET / ORAL | AB | 1983-11-10 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | N018823-002 | FUROSEMIDE | 40MG | TABLET / ORAL | AB | 1983-11-10 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N018823-001 | FUROSEMIDE | 20MG | TABLET / ORAL | AB | 1983-11-10 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N018823-002 | FUROSEMIDE | 40MG | TABLET / ORAL | AB | 1983-11-10 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N018823-001 | FUROSEMIDE | 20MG | TABLET / ORAL | AB | 1983-11-10 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N018823-002 | FUROSEMIDE | 40MG | TABLET / ORAL | AB | 1983-11-10 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N018823-001 | FUROSEMIDE | 20MG | TABLET / ORAL | AB | 1983-11-10 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N018823-002 | FUROSEMIDE | 40MG | TABLET / ORAL | AB | 1983-11-10 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N018823-001 | FUROSEMIDE | 20MG | TABLET / ORAL | AB | 1983-11-10 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N018823-002 | FUROSEMIDE | 40MG | TABLET / ORAL | AB | 1983-11-10 | 74a2ff9319b5… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N018823-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N018823-002 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N018823-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N018823-002 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N018823-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N018823-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018823-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018823-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N018823-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N018823-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018823-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018823-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018823-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018823-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018823-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018823-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018823-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018823-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018823-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018823-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N018823-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N018823-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N018823-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N018823-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N018823-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N018823-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N018823-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N018823-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N018823-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N018823-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N018823-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N018823-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N018823-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N018823-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N018823-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N018823-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N018823-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N018823-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N018823-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N018823-002 | AB | 1 | 74a2ff9319b5… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Furosemide
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| FUROSEMIDE | 40 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 7LXU5N7ZO5 | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 9e493331-dddd-496e-abf8-61747fb67aba | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| d80d3aff-3a63-4d7b-a2be-fd9388b04330 | Product name | 9 | 20250806 |
| 9061e89f-9c86-4196-b34b-886fc1673cc4 | Product name | 1 | 20140821 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Related label |
|---|---|---|
| 0054-4299-25 | 2022-08-05 | Furosemide Tablets, USP and Furosemide Oral Solution, USP Rx only |
| 0054-4299-31 | 2022-08-05 | Furosemide Tablets, USP and Furosemide Oral Solution, USP Rx only |
| 0054-4299-25 | 2022-07-29 | Furosemide Tablets, USP and Furosemide Oral Solution, USP Rx only |
| 0054-4299-31 | 2022-07-29 | Furosemide Tablets, USP and Furosemide Oral Solution, USP Rx only |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0054-4299-25 | Furosemide | 100 in 1 BOTTLE | TABLET | 100 | 18 | |
| 0054-4299-31 | Furosemide | 1000 in 1 BOTTLE | TABLET | 1000 | 18 | |
| 0054-4299-25 | Furosemide | 100 in 1 BOTTLE | TABLET | 100 | 1 | |
| 0054-4299-31 | Furosemide | 1000 in 1 BOTTLE | TABLET | 1000 | 1 | |
| 0054-8299-25 | Furosemide | 10 in 1 BOX | TABLET | 10 | 1 | |
| 0054-8299-25 | Furosemide | 100 in 1 BLISTER PACK | TABLET | 100 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0054-4299-25 | EA - Each | 0054-4299 | 5927e536-cfbc-48da-bdc7-0b1d203cd2af | 1 | 2012-07-24 |
| 0054-4299-31 | EA - Each | 0054-4299 | 4a7d718f-8b9a-4f87-ada8-b6d22d6efef7 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0054-4299 | FUROSEMIDE TABLET FUROSEMIDE SOLUTION [HIKMA PHARMACEUTICALS USA INC.] | 16 | Current NDC, Legacy NDC, 2 package rows | 20250511_9e493331-dddd-496e-abf8-61747fb67aba.zip |
| 0054-4299 | FUROSEMIDE (FUROSEMIDE) TABLET FUROSEMIDE (FUROSEMIDE) SOLUTION [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.] | 1 | Current NDC, Legacy NDC, 4 package rows | 20070509_EA623E21-E9FD-4EF1-843B-82CBC05AF5BF.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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Furosemide | FUROSEMIDE | Northwind Health Company, LLC | f3173c0d-2b62-7c7b-e053-2995a90ada05 | 2026-01-01 | Warnings, Adverse reactions | 018823 NDA018823 |
| Furosemide | FUROSEMIDE | Hikma Pharmaceuticals USA Inc. | 9e493331-dddd-496e-abf8-61747fb67aba | 2025-11-03 | Warnings, Adverse reactions | 018823 NDA018823 0054-4299-25 0054-4299 00054429925 |
| Furosemide | FUROSEMIDE | A-S Medication Solutions | a2e46e16-4adf-4599-b69d-a6f6f891ba75 | 2023-10-31 | Warnings, Adverse reactions | 018823 NDA018823 |
| Furosemide | FUROSEMIDE | Aphena Pharma Solutions - Tennessee, LLC | 6fbf7f3d-7566-44d5-9507-c4460238fc91 | 2018-02-09 | Warnings, Adverse reactions | 018823 NDA018823 |
DailyMed RxNorm Mappings#
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0054-4299-25 | 00054429925 | 100 TABLET in 1 BOTTLE (0054-4299-25) | 100 tablet | 1983-11-10 | 0000-00-00 | No | No | Current |