Prescription drug · NDA
Halaven (Eribulin mesylate) NDC 43624-002
Eribulin mesylate 1 mg/2mL · Injection · Intravenous · BSP Pharmaceuticals SpA
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43624-002-01 | 4362400020143624000201 | 100 VIAL in 1 TRAY (43624-002-01) / 2 mL in 1 VIALMarketed from Apr 21, 2017 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Halaven
- Generic name (nonproprietary)
- eribulin mesylate
- Active ingredients
- Eribulin mesylate — 1 mg/2mL
- Dosage form
- Injection
- Route
- Intravenous
- Labeler
- BSP Pharmaceuticals SpANDC labeler code 43624
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 201532
- Marketing start
- Listing expires
- Other FDA classes
- Microtubule Inhibition (Physiologic effect)
- Identifiers
- Product ID 43624-002_494dbaab-6ded-549d-e063-6394a90a4022SPL ID 494dbaab-6ded-549d-e063-6394a90a4022SPL set ID 8fc8fe1d-59fe-4e43-a95c-e7aa13422cd6RxCUI 1045456, 1045460UNII AV9U0660CW
- Pharmacologic class
- Microtubule Inhibitor
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N443624000201followed by a unit qualifier and the quantityPackage 43624-0002-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
About NDC 43624-002
- What is NDC 43624-002?
- 43624-002 is the product NDC for Halaven (eribulin mesylate), Eribulin mesylate 1 mg/2mL injection, listed with the FDA by BSP Pharmaceuticals SpA. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Halaven (Eribulin mesylate).
- What is the active ingredient?
- Eribulin mesylate.
- Who is the labeler?
- BSP Pharmaceuticals SpA, NDC labeler code 43624. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Halaven?
- 1 other product NDC are listed under this name. See all Halaven NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Halaven products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Halaveneribulin mesylate | Eribulin mesylate .5 mg/mL | InjectionIntravenous | Eisai Inc. | 62856-389 | 62856-0389-01 |
Other NDCs under NDA 201532
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Halaveneribulin mesylate | Eribulin mesylate .5 mg/mL | InjectionIntravenous | Eisai Inc. | 62856-389 |