Prescription drug · ANDA
eribulin mesylate NDC 60505-6435
Eribulin mesylate .5 mg/mL · Injection · Intravenous · Apotex Corp.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 60505-6435-0 | 6050564350060505643500 | 1 VIAL, SINGLE-DOSE in 1 CARTON (60505-6435-0) / 2 mL in 1 VIAL, SINGLE-DOSEMarketed from Mar 19, 2025 |
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
- Injection
- Route
- Intravenous
- Labeler
- Apotex Corp.NDC labeler code 60505
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 218047
- Marketing start
- Listing expires
- Other FDA classes
- Microtubule Inhibition (Physiologic effect)
- Identifiers
- Product ID 60505-6435_7324bf15-e9e4-547d-b434-0731724875ebSPL ID 7324bf15-e9e4-547d-b434-0731724875eb
- 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
N460505643500followed by a unit qualifier and the quantityPackage 60505-6435-00. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 60505-6435
- What is NDC 60505-6435?
- 60505-6435 is the product NDC for eribulin mesylate, Eribulin mesylate .5 mg/mL injection, listed with the FDA by Apotex Corp.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- eribulin mesylate.
- What is the active ingredient?
- Eribulin mesylate.
- Who is the labeler?
- Apotex Corp., NDC labeler code 60505. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for eribulin mesylate?
- 14 other product NDCs are listed under this name. See all eribulin mesylate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other eribulin mesylate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Eribulin Mesylate | Eribulin mesylate .5 mg/mL | InjectionIntravenous | XGen Pharmaceuticals DJB, Inc. | 39822-2080 | 39822-2080-01 |
| Eribulin Mesylate | Eribulin mesylate .5 mg/mL | InjectionIntravenous | Dr. Reddys Laboratories Inc | 43598-125 | 43598-0125-11 |
| Eribulin Mesylate | Eribulin mesylate .5 mg/mL | SolutionIntravenous | Northstar Rx LLC | 72603-368 | 72603-0368-01 |
| Eribulin Mesylate | Eribulin mesylate .5 mg/mL | SolutionIntravenous | BluePoint Laboratories | 68001-656 | 68001-0656-41 |
| Eribulin Mesylate | Eribulin mesylate .5 mg/mL | InjectionIntravenous | Kindos Pharmaceuticals Co., Ltd. | 40033-364 | 40033-0364-01 |
| Eribulin Mesylate | Eribulin mesylate .5 mg/mL | InjectionIntravenous | GLENMARK PHARMACEUTICALS INC., USA | 68462-770 | 68462-0770-20 |
| Eribulin Mesylate | Eribulin mesylate .5 mg/mL | InjectionIntravenous | Sandoz Inc | 0781-3391 | 00781-3391-94 |
| Eribulin Mesylate | Eribulin mesylate .5 mg/mL | InjectionIntravenous | Sun Pharmaceutical Industries Limited | 70095-080 | 70095-0080-01 |
| Eribulin Mesylate | Eribulin mesylate .5 mg/mL | InjectionIntravenous | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | 71731-4171 | 71731-4171-01 |
| Eribulin Mesylate | Eribulin mesylate .5 mg/mL | InjectionIntravenous | Baxter Healthcare Company | 10019-080 | 10019-0080-01 |
Other NDCs under ANDA 218047
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 | InjectionIntravenous | Apotex Corp. | 60505-6289 |
| eribulin mesylate | Eribulin mesylate .5 mg/mL | InjectionIntravenous | Gland Pharma Limited | 68083-592 |