Halaven®
(eribulin mesylate) Injection, for intravenous use
1 mg/2 mL (0.5 mg/mL)
Halaven - BSP Pharmaceuticals SpA
- Manufacturer
- BSP Pharmaceuticals SpA
- Effective date
- 2026-01-26
- Label type
- HUMAN PRESCRIPTION DRUG LABEL
- Version
- 58
- Source
- full-release
- Hydrated at
- 2026-05-31 22:19:18
Label at a glance#
ProductHalaven
Active ingredientERIBULIN MESYLATE
Label structure2 sections
Label contents#
Full prescribing information#
PRINCIPAL DISPLAY PANEL - SHIPPER LABEL
Eisai Manufacturing Limited
Allegato DQA-035/XXXX
New Chemical Entity Demand Chain Unit European Knowledge Centre
Mosquito Way-Hatfield, Herts, AL 109SN
United Kingdom
HALAVEN®
(eribulin mesylate) Injection, for intravenous use- 0.5mg/ml, 2 ml
Store at 15° - 25°C (59° - 77°F). DO NOT FREEZE
QTY: 00XXX EXP: MM-YYYY LOT: F1XXYZZZ
(22) 900XXX MMYYYY F1XXYZZZ 7
NDC 43624-002-01
(0X) 50X XXXXX 00X X X0 XXX
Manufactured by : BSP Pharmaceuticals SpA-Latina Scalo, Italy.
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1045456 | eriBULin mesylate 1 MG in 2 ML Injection | PSN | 58 |
| 1045460 | Halaven 1 MG in 2 ML Injection | PSN | 58 |
| 1045460 | 2 ML eribulin mesylate 0.5 MG/ML Injection [Halaven] | SBD | 58 |
| 1045456 | 2 ML eribulin mesylate 0.5 MG/ML Injection | SCD | 58 |
| 1045460 | 2 ML Halaven 0.5 MG/ML Injection | SY | 58 |
| 1045456 | eribulin mesylate 1 MG per 2 ML Injection | SY | 58 |
| 1045460 | Halaven 1 MG per 2 ML Injection | SY | 58 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| ERIBULIN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| f2cc096b-1048-9b7c-d909-76a5ea566cbf | Product name | 3 | 20251210 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 43624-002-01 | Halaven | 100 in 1 TRAY | INJECTION | 100 | 58 | |
| 43624-002-01 | Halaven | 2 mL in 1 VIAL | INJECTION | 2 | 58 |
Products#
Every source-derived product name is available through these pages.
- Halaven
- eribulin mesylate
- WATER
- ERIBULIN
- ALCOHOL
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 43624-002 | 43624-002-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| WATER | 059QF0KO0R | IACT |
| ERIBULIN MESYLATE | AV9U0660CW | ACTIB |
| ALCOHOL | 3K9958V90M | IACT |
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 57 | 2025-12-24 | monthly-update | 2026-06-03 17:48:57 |
Orange Book application contexts#
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N201532-001 | HALAVEN | ERIBULIN MESYLATE | 1MG/2ML (0.5MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2010-11-15 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N201532-001 | AP |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N201532-001 | RE46965 | 2027-01-08 | Drug product | 2018-08-07 | |
| N201532-001 | RE46965*PED | 2027-07-08 | Pediatric extension |
Orange Book exclusivity#
| Application-product | Exclusivity code | Expiration |
|---|---|---|
| N201532-001 | M-280 | 2025-09-13 |
| N201532-001 | PED | 2026-03-13 |
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 | N201532-001 | HALAVEN | 1MG/2ML (0.5MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2010-11-15 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N201532-001 | HALAVEN | 1MG/2ML (0.5MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2010-11-15 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N201532-001 | HALAVEN | 1MG/2ML (0.5MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2010-11-15 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N201532-001 | HALAVEN | 1MG/2ML (0.5MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2010-11-15 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N201532-001 | HALAVEN | 1MG/2ML (0.5MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2010-11-15 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N201532-001 | HALAVEN | 1MG/2ML (0.5MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2010-11-15 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N201532-001 | HALAVEN | 1MG/2ML (0.5MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2010-11-15 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N201532-001 | HALAVEN | 1MG/2ML (0.5MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2010-11-15 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N201532-001 | HALAVEN | 1MG/2ML (0.5MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2010-11-15 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N201532-001 | HALAVEN | 1MG/2ML (0.5MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2010-11-15 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N201532-001 | HALAVEN | 1MG/2ML (0.5MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2010-11-15 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N201532-001 | HALAVEN | 1MG/2ML (0.5MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2010-11-15 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N201532-001 | HALAVEN | 1MG/2ML (0.5MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2010-11-15 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N201532-001 | HALAVEN | 1MG/2ML (0.5MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2010-11-15 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N201532-001 | HALAVEN | 1MG/2ML (0.5MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2010-11-15 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N201532-001 | HALAVEN | 1MG/2ML (0.5MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2010-11-15 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N201532-001 | HALAVEN | 1MG/2ML (0.5MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2010-11-15 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N201532-001 | HALAVEN | 1MG/2ML (0.5MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2010-11-15 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N201532-001 | HALAVEN | 1MG/2ML (0.5MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2010-11-15 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N201532-001 | HALAVEN | 1MG/2ML (0.5MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2010-11-15 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N201532-001 | HALAVEN | 1MG/2ML (0.5MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2010-11-15 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N201532-001 | HALAVEN | 1MG/2ML (0.5MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2010-11-15 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N201532-001 | HALAVEN | 1MG/2ML (0.5MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2010-11-15 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | N201532-001 | HALAVEN | 1MG/2ML (0.5MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2010-11-15 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | N201532-001 | HALAVEN | 1MG/2ML (0.5MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2010-11-15 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | N201532-001 | HALAVEN | 1MG/2ML (0.5MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2010-11-15 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | N201532-001 | HALAVEN | 1MG/2ML (0.5MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2010-11-15 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | N201532-001 | HALAVEN | 1MG/2ML (0.5MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2010-11-15 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | N201532-001 | HALAVEN | 1MG/2ML (0.5MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2010-11-15 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N201532-001 | HALAVEN | 1MG/2ML (0.5MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2010-11-15 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N201532-001 | HALAVEN | 1MG/2ML (0.5MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2010-11-15 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N201532-001 | HALAVEN | 1MG/2ML (0.5MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2010-11-15 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N201532-001 | HALAVEN | 1MG/2ML (0.5MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2010-11-15 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N201532-001 | HALAVEN | 1MG/2ML (0.5MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2010-11-15 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N201532-001 | HALAVEN | 1MG/2ML (0.5MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2010-11-15 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N201532-001 | HALAVEN | 1MG/2ML (0.5MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2010-11-15 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N201532-001 | HALAVEN | 1MG/2ML (0.5MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2010-11-15 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | N201532-001 | HALAVEN | 1MG/2ML (0.5MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2010-11-15 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N201532-001 | HALAVEN | 1MG/2ML (0.5MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2010-11-15 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | N201532-001 | HALAVEN | 1MG/2ML (0.5MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2010-11-15 | f41ea6bd6efb… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N201532-001 | AP | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N201532-001 | AP | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N201532-001 | AP | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N201532-001 | AP | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N201532-001 | AP | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N201532-001 | AP | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N201532-001 | AP | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N201532-001 | AP | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N201532-001 | AP | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N201532-001 | AP | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N201532-001 | AP | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N201532-001 | AP | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N201532-001 | AP | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N201532-001 | AP | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N201532-001 | AP | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N201532-001 | AP | 1 | 8072bd15b7f6… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N201532-001 | AP | 1 | a50c72e98297… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N201532-001 | RE46965 | 2027-01-08 | Drug product | 2018-08-07 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N201532-001 | RE46965*PED | 2027-07-08 | Pediatric extension | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | N201532-001 | RE46965 | 2027-01-08 | Drug product | 2018-08-07 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N201532-001 | RE46965*PED | 2027-07-08 | Pediatric extension | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N201532-001 | RE46965 | 2027-01-08 | Drug product | 2018-08-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N201532-001 | RE46965*PED | 2027-07-08 | Pediatric extension | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N201532-001 | RE46965 | 2027-01-08 | Drug product | 2018-08-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N201532-001 | RE46965*PED | 2027-07-08 | Pediatric extension | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N201532-001 | RE46965 | 2027-01-08 | Drug product | 2018-08-07 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N201532-001 | RE46965*PED | 2027-07-08 | Pediatric extension | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N201532-001 | RE46965 | 2027-01-08 | Drug product | 2018-08-07 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N201532-001 | RE46965*PED | 2027-07-08 | Pediatric extension | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N201532-001 | RE46965 | 2027-01-08 | Drug product | 2018-08-07 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N201532-001 | RE46965*PED | 2027-07-08 | Pediatric extension | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N201532-001 | 6214865*PED | 2024-01-20 | Pediatric extension | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N201532-001 | RE46965 | 2027-01-08 | Drug product | 2018-08-07 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N201532-001 | RE46965*PED | 2027-07-08 | Pediatric extension | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N201532-001 | 6214865*PED | 2024-01-20 | Pediatric extension | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N201532-001 | RE46965 | 2027-01-08 | Drug product | 2018-08-07 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N201532-001 | RE46965*PED | 2027-07-08 | Pediatric extension | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N201532-001 | 6214865*PED | 2024-01-20 | Pediatric extension | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N201532-001 | RE46965 | 2027-01-08 | Drug product | 2018-08-07 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N201532-001 | RE46965*PED | 2027-07-08 | Pediatric extension | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N201532-001 | 6214865*PED | 2024-01-20 | Pediatric extension | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N201532-001 | RE46965 | 2027-01-08 | Drug product | 2018-08-07 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N201532-001 | RE46965*PED | 2027-07-08 | Pediatric extension | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N201532-001 | 6214865*PED | 2024-01-20 | Pediatric extension | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N201532-001 | RE46965 | 2027-01-08 | Drug product | 2018-08-07 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N201532-001 | RE46965*PED | 2027-07-08 | Pediatric extension | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N201532-001 | 6214865*PED | 2024-01-20 | Pediatric extension | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N201532-001 | RE46965 | 2027-01-08 | Drug product | 2018-08-07 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N201532-001 | RE46965*PED | 2027-07-08 | Pediatric extension | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N201532-001 | 6214865*PED | 2024-01-20 | Pediatric extension | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N201532-001 | RE46965 | 2027-01-08 | Drug product | 2018-08-07 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N201532-001 | RE46965*PED | 2027-07-08 | Pediatric extension | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N201532-001 | 6214865*PED | 2024-01-20 | Pediatric extension | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N201532-001 | RE46965 | 2027-01-08 | Drug product | 2018-08-07 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N201532-001 | RE46965*PED | 2027-07-08 | Pediatric extension | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N201532-001 | 6214865*PED | 2024-01-20 | Pediatric extension | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N201532-001 | RE46965 | 2027-01-08 | Drug product | 2018-08-07 | 8072bd15b7f6… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N201532-001 | M-280 | 2025-09-13 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N201532-001 | PED | 2026-03-13 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N201532-001 | M-280 | 2025-09-13 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N201532-001 | PED | 2026-03-13 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N201532-001 | M-280 | 2025-09-13 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N201532-001 | PED | 2026-03-13 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N201532-001 | M-280 | 2025-09-13 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N201532-001 | PED | 2026-03-13 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N201532-001 | M-280 | 2025-09-13 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N201532-001 | PED | 2026-03-13 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N201532-001 | M-280 | 2025-09-13 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N201532-001 | PED | 2026-03-13 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N201532-001 | M-280 | 2025-09-13 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N201532-001 | PED | 2026-03-13 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N201532-001 | M-280 | 2025-09-13 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N201532-001 | PED | 2026-03-13 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N201532-001 | M-280 | 2025-09-13 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N201532-001 | PED | 2026-03-13 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N201532-001 | M-280 | 2025-09-13 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N201532-001 | PED | 2026-03-13 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N201532-001 | M-280 | 2025-09-13 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N201532-001 | PED | 2026-03-13 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N201532-001 | M-280 | 2025-09-13 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N201532-001 | PED | 2026-03-13 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N201532-001 | M-280 | 2025-09-13 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N201532-001 | PED | 2026-03-13 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N201532-001 | M-280 | 2025-09-13 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N201532-001 | PED | 2026-03-13 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N201532-001 | M-280 | 2025-09-13 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N201532-001 | PED | 2026-03-13 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N201532-001 | M-280 | 2025-09-13 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N201532-001 | PED | 2026-03-13 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N201532-001 | ODE-107 | 2023-01-28 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N201532-001 | ODE-107 | 2023-01-28 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N201532-001 | ODE-107 | 2023-01-28 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N201532-001 | I-721 | 2019-01-28 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N201532-001 | ODE-107 | 2023-01-28 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N201532-001 | ODE-107 | 2023-01-28 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N201532-001 | ODE-107 | 2023-01-28 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N201532-001 | ODE-107 | 2023-01-28 | 87673890dc5c… |
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 |
|---|---|---|---|---|---|---|
| Halaven | ERIBULIN MESYLATE | BSP Pharmaceuticals SpA | 8fc8fe1d-59fe-4e43-a95c-e7aa13422cd6 | 2026-01-26 | 43624-002-01 43624-002 43624000201 494dbaab-6ded-549d-e063-6394a90a4022 8fc8fe1d-59fe-4e43-a95c-e7aa13422cd6 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.