Prescription drug · ANDA
eribulin mesylate NDC 68083-592
Eribulin mesylate .5 mg/mL · Injection · Intravenous · Gland Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68083-592-01 | 6808305920168083059201 | 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 LimitedNDC labeler code 68083
- 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 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.
- NDC on a medical claim
N468083059201followed by a unit qualifier and the quantityPackage 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 .
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.
About NDC 68083-592
- What is NDC 68083-592?
- 68083-592 is the product NDC for eribulin mesylate, Eribulin mesylate .5 mg/mL injection, listed with the FDA by Gland Pharma Limited. 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?
- Gland Pharma Limited, NDC labeler code 68083. 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 | Apotex Corp. | 60505-6435 | 60505-6435-00 |
| Eribulin Mesylate | Eribulin mesylate .5 mg/mL | InjectionIntravenous | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | 71731-4171 | 71731-4171-01 |
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 | Apotex Corp. | 60505-6435 |