Prescription drug · ANDA
Eribulin Mesylate NDC 81298-3890
Eribulin mesylate .5 mg/mL · Solution · Intravenous · Long Grove Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 81298-3890-1 | 81298389001 | 1 VIAL, SINGLE-DOSE in 1 CARTON (81298-3890-1) / 2 mL in 1 VIAL, SINGLE-DOSEMarketed from Jul 22, 2024 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Eribulin Mesylate
- Generic name (nonproprietary)
- eribulin mesylate
- Active ingredients
- Eribulin mesylate — .5 mg/mL
- Dosage form
- Solution
- Route
- Intravenous
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 214850
- Marketing start
- Listing expires
- Other FDA classes
- Microtubule Inhibition (Physiologic effect)
- Identifiers
- Product ID 81298-3890_68589863-7488-4661-bbbe-9838b7d0396dSPL ID 68589863-7488-4661-bbbe-9838b7d0396dSPL set ID 4a64918a-f674-4843-b544-ab815fdd1b8fRxCUI 1045456UNII AV9U0660CWUPC 0381298389016
- 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
N481298389001followed by a unit qualifier and the quantityPackage 81298-3890-01. 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)
Eribulin Mesylate Injection 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 Metastatic Breast Cancer Eribulin mesylate injection 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. …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 214850
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 |
|---|---|---|---|---|
| Eribulin Mesylate | Eribulin mesylate .5 mg/mL | SolutionIntravenous | Northstar Rx LLC | 72603-368 |
| Eribulin Mesylate | Eribulin mesylate .5 mg/mL | SolutionIntravenous | BluePoint Laboratories | 68001-656 |