Halaven
- Product NDC
- 43624-002
- 11-digit product format
- 436240002
- Labeler code
- 43624
- Product ID
- 43624-002_494dbaab-6ded-549d-e063-6394a90a4022
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- eribulin mesylate
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- BSP Pharmaceuticals SpA
- Application
- NDA201532
- Marketing category
- NDA
- Marketing start
- 2017-04-21
- Substance
- ERIBULIN MESYLATE
- Active strength
- 1 mg/2mL
- Pharmacologic classes
- Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Halaven
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ERIBULIN MESYLATE | 1 mg/2mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | AV9U0660CW |
| Rxcui | 1045456, 1045460 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| 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 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43624-002 | HALAVEN (ERIBULIN MESYLATE) INJECTION [BSP PHARMACEUTICALS SPA] | 55 | Current NDC, Legacy NDC, 2 package rows | 20241102_8fc8fe1d-59fe-4e43-a95c-e7aa13422cd6.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 43624-002-01 | 43624000201 | 100 VIAL in 1 TRAY (43624-002-01) / 2 mL in 1 VIAL | 100 vial | 2017-04-21 | 0000-00-00 | No | No | Current |