Prescription drug · NDA
Halaven (eribulin mesylate) NDC 62856-389
Eribulin mesylate .5 mg/mL · Injection · Intravenous · Eisai Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62856-389-01 | 62856038901 | 1 VIAL, SINGLE-DOSE in 1 CARTON (62856-389-01) / 2 mL in 1 VIAL, SINGLE-DOSEMarketed from Nov 15, 2010 |
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 — .5 mg/mL
- Dosage form
- Injection
- Route
- Intravenous
- Labeler
- Eisai Inc.
- 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 62856-389_2c75a415-0b1e-4c36-8301-c50ac155d980SPL ID 2c75a415-0b1e-4c36-8301-c50ac155d980SPL set ID 31ce4750-ded5-4a0b-95e9-f229fa6bc822RxCUI 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
N462856038901followed by a unit qualifier and the quantityPackage 62856-0389-01. 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 .
Indications (excerpt from the label)
HALAVEN is a microtubule inhibitor indicated for the treatment of patients with: Metastatic breast cancer who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting. ( 1.1 ) Unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen. ( 1.2 ) 1.1 Me tastatic Breast Cancer HALAVEN is indicated for the treatment of patients with metastatic breast cancer who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease. Prior therapy should have included an a…
Excerpt only. Read the full label for complete information.
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 1 mg/2mL | InjectionIntravenous | BSP Pharmaceuticals SpA | 43624-002 |