Furosemide
- Product NDC
- 0054-3298
- Requested package NDC
- 0054-3298-63
- 11-digit product format
- 000543298
- Labeler code
- 0054
- Product ID
- 0054-3298_bc62ddda-7639-4090-99f0-7dd4d13518f3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Furosemide
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA070433
- Marketing category
- ANDA
- Marketing start
- 1987-04-22
- Substance
- FUROSEMIDE
- Active strength
- 40 mg/5mL
- 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 |
|---|---|---|---|---|---|---|---|
| A070433-001 | FUROSEMIDE | FUROSEMIDE | 40MG/5ML | SOLUTION / ORAL | RS | 1987-04-22 |
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 | A070433-001 | FUROSEMIDE | 40MG/5ML | SOLUTION / ORAL | RS | 1987-04-22 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A070433-001 | FUROSEMIDE | 40MG/5ML | SOLUTION / ORAL | RS | 1987-04-22 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A070433-001 | FUROSEMIDE | 40MG/5ML | SOLUTION / ORAL | RS | 1987-04-22 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A070433-001 | FUROSEMIDE | 40MG/5ML | SOLUTION / ORAL | 1987-04-22 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A070433-001 | FUROSEMIDE | 40MG/5ML | SOLUTION / ORAL | 1987-04-22 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A070433-001 | FUROSEMIDE | 40MG/5ML | SOLUTION / ORAL | 1987-04-22 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A070433-001 | FUROSEMIDE | 40MG/5ML | SOLUTION / ORAL | 1987-04-22 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A070433-001 | FUROSEMIDE | 40MG/5ML | SOLUTION / ORAL | 1987-04-22 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A070433-001 | FUROSEMIDE | 40MG/5ML | SOLUTION / ORAL | 1987-04-22 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A070433-001 | FUROSEMIDE | 40MG/5ML | SOLUTION / ORAL | 1987-04-22 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A070433-001 | FUROSEMIDE | 40MG/5ML | SOLUTION / ORAL | 1987-04-22 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A070433-001 | FUROSEMIDE | 40MG/5ML | SOLUTION / ORAL | 1987-04-22 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A070433-001 | FUROSEMIDE | 40MG/5ML | SOLUTION / ORAL | 1987-04-22 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A070433-001 | FUROSEMIDE | 40MG/5ML | SOLUTION / ORAL | 1987-04-22 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A070433-001 | FUROSEMIDE | 40MG/5ML | SOLUTION / ORAL | 1987-04-22 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A070433-001 | FUROSEMIDE | 40MG/5ML | SOLUTION / ORAL | 1987-04-22 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A070433-001 | FUROSEMIDE | 40MG/5ML | SOLUTION / ORAL | 1987-04-22 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A070433-001 | FUROSEMIDE | 40MG/5ML | SOLUTION / ORAL | 1987-04-22 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A070433-001 | FUROSEMIDE | 40MG/5ML | SOLUTION / ORAL | 1987-04-22 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A070433-001 | FUROSEMIDE | 40MG/5ML | SOLUTION / ORAL | 1987-04-22 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A070433-001 | FUROSEMIDE | 40MG/5ML | SOLUTION / ORAL | 1987-04-22 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A070433-001 | FUROSEMIDE | 40MG/5ML | SOLUTION / ORAL | 1987-04-22 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A070433-001 | FUROSEMIDE | 40MG/5ML | SOLUTION / ORAL | 1987-04-22 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A070433-001 | FUROSEMIDE | 40MG/5ML | SOLUTION / ORAL | 1987-04-22 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A070433-001 | FUROSEMIDE | 40MG/5ML | SOLUTION / ORAL | 1987-04-22 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A070433-001 | FUROSEMIDE | 40MG/5ML | SOLUTION / ORAL | 1987-04-22 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A070433-001 | FUROSEMIDE | 40MG/5ML | SOLUTION / ORAL | 1987-04-22 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A070433-001 | FUROSEMIDE | 40MG/5ML | SOLUTION / ORAL | 1987-04-22 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A070433-001 | FUROSEMIDE | 40MG/5ML | SOLUTION / ORAL | 1987-04-22 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A070433-001 | FUROSEMIDE | 40MG/5ML | SOLUTION / ORAL | 1987-04-22 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A070433-001 | FUROSEMIDE | 40MG/5ML | SOLUTION / ORAL | 1987-04-22 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A070433-001 | FUROSEMIDE | 40MG/5ML | SOLUTION / ORAL | 1987-04-22 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A070433-001 | FUROSEMIDE | 40MG/5ML | SOLUTION / ORAL | 1987-04-22 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A070433-001 | FUROSEMIDE | 40MG/5ML | SOLUTION / ORAL | 1987-04-22 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A070433-001 | FUROSEMIDE | 40MG/5ML | SOLUTION / ORAL | 1987-04-22 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A070433-001 | FUROSEMIDE | 40MG/5ML | SOLUTION / ORAL | 1987-04-22 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A070433-001 | FUROSEMIDE | 40MG/5ML | SOLUTION / ORAL | 1987-04-22 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A070433-001 | FUROSEMIDE | 40MG/5ML | SOLUTION / ORAL | 1987-04-22 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A070433-001 | FUROSEMIDE | 40MG/5ML | SOLUTION / ORAL | 1987-04-22 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A070433-001 | FUROSEMIDE | 40MG/5ML | SOLUTION / ORAL | 1987-04-22 | f41ea6bd6efb… |
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/5mL |
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 | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 0054-3298-63 | 2022-08-05 | C162847 | 48780-1 | e4f33bdf-a7a2-d8a0-e053-dadaa90a6e4e | Furosemide Tablets, USP and Furosemide Oral Solution, USP Rx only |
| 0054-3298-63 | 2022-07-29 | C162847 | 48780-1 | e4f33bdf-a7a2-d8a0-e053-dadaa90a6e4e | Furosemide Tablets, USP and Furosemide Oral Solution, USP Rx only |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0054-3298-63 | Furosemide | 500 mL in 1 BOTTLE, PLASTIC | SOLUTION | 500 | 18 | |
| 0054-3298-63 | Furosemide | 500 mL in 1 BOTTLE, PLASTIC | SOLUTION | 500 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0054-3298-63 | ML - Milliliter | 0054-3298 | fc59355f-cba5-41a5-ac6a-88fdfd1435b4 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0054-3298 | FUROSEMIDE TABLET FUROSEMIDE SOLUTION [HIKMA PHARMACEUTICALS USA INC.] | 16 | Current NDC, Legacy NDC, 1 package rows | 20250511_9e493331-dddd-496e-abf8-61747fb67aba.zip |
| 0054-3298 | FUROSEMIDE (FUROSEMIDE) TABLET FUROSEMIDE (FUROSEMIDE) SOLUTION [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.] | 1 | Current NDC, Legacy NDC | 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 | Atlantic Biologicals Corps | 9c342198-7162-4cc5-bda1-bc4054a4292b | 2026-06-16 | Warnings, Adverse reactions | 070433 ANDA070433 |
| Furosemide | FUROSEMIDE | Hikma Pharmaceuticals USA Inc. | 9e493331-dddd-496e-abf8-61747fb67aba | 2025-11-03 | Warnings, Adverse reactions | 070433 ANDA070433 0054-3298-63 0054-3298 00054329863 |
| Furosemide | FUROSEMIDE | Precision Dose Inc. | 3fd02fb5-98a0-4eda-a0ec-41faabe04706 | 2024-06-13 | Warnings, Adverse reactions | 070433 ANDA070433 |
DailyMed RxNorm Mappings#
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0054-3298-63 | 00054329863 | 500 mL in 1 BOTTLE, PLASTIC (0054-3298-63) | 500 ml | 1987-04-22 | 0000-00-00 | No | No | Current |