eribulin mesylate NDC 68083-592

NDC codes

FDA NDC Directory

Product NDC (as listed)68083-592Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68083-0592Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
68083-592-01	68083059201	1 VIAL, SINGLE-DOSE in 1 CARTON (68083-592-01) / 2 mL in 1 VIAL, SINGLE-DOSEMarketed from Apr 5, 2024

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): eribulin mesylate
Generic name (nonproprietary): eribulin mesylate
Active ingredients: Eribulin mesylate — .5 mg/mL
Dosage form: Injection
Route: Intravenous
Labeler: Gland Pharma Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 218047
Marketing start: Apr 5, 2024
Listing expires: Dec 31, 2027
Other FDA classes: Microtubule Inhibition (Physiologic effect)
Identifiers: Product ID 68083-592_53ee1a1d-b0ee-4e53-ab22-7eea2d583be9SPL ID 53ee1a1d-b0ee-4e53-ab22-7eea2d583be9SPL set ID f57835e2-4c53-4e93-b54b-7d7a5000ae3dRxCUI 1045456UNII 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.

How CPT relates to drug billing

NDC on a medical claim

N468083059201 followed by a unit qualifier and the quantity

Package 68083-0592-01. 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 Jul 21, 2026.

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.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 218047

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 218047
Product	Strength	Form · route	Labeler	Product NDC
eribulin mesylate	Eribulin mesylate .5 mg/mL	InjectionIntravenous	Apotex Corp.	60505-6289
eribulin mesylate	Eribulin mesylate .5 mg/mL	InjectionIntravenous	Apotex Corp.	60505-6435