Prescription drug · BLA
Releuko (filgrastim) NDC 70121-1568
Filgrastim 300 ug/.5mL · Injection, Solution · Intravenous, Subcutaneous · Amneal Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70121-1568-1 | 70121156801 | 1 SYRINGE in 1 BOX (70121-1568-1) / .5 mL in 1 SYRINGEMarketed from Feb 25, 2022 | |
| 70121-1568-7 | 70121156807 | 10 SYRINGE in 1 BOX (70121-1568-7) / .5 mL in 1 SYRINGEMarketed from Feb 25, 2022 |
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)
- Releuko
- Generic name (nonproprietary)
- filgrastim
- Active ingredients
- Filgrastim — 300 ug/.5mL
- Dosage form
- Injection, Solution
- Route
- Intravenous, Subcutaneous
- Labeler
- Amneal Pharmaceuticals LLC
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761082
- Marketing start
- Listing expires
- Other FDA classes
- Granulocyte Colony-Stimulating Factor (Chemical structure)Increased Myeloid Cell Production (Physiologic effect)
- Identifiers
- Product ID 70121-1568_7dd755fd-d4fe-431a-97a2-1ded5cf1a24bSPL ID 7dd755fd-d4fe-431a-97a2-1ded5cf1a24bSPL set ID 74e1ec6e-1630-4654-895c-2bd355f939e7RxCUI 2595944, 2595950, 2595953, 2595957, 2595959, 2595960, 2595961, 2595962UNII PVI5M0M1GWUPC 0370121156970, 0370121156819, 0370121157014, 0370121156871, 0370121157175, 0370121157076
- Pharmacologic class
- Leukocyte Growth Factor
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
N470121156801followed by a unit qualifier and the quantityPackage 70121-1568-01. 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)
RELEUKO is a leukocyte growth factor indicated to: Decrease the incidence of infection‚ as manifested by febrile neutropenia‚ in patients with nonmyeloid malignancies receiving myelosuppressive anti- cancer drugs associated with a significant incidence of severe neutropenia with fever. ( 1.1 ) Reduce the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia (AML). ( 1.2 ) Reduce the duration of neutropenia and neutropenia-related clinical sequelae‚ e.g.‚ febrile neutropenia, in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation …
Excerpt only. Read the full label for complete information.
Other NDCs under BLA 761082
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 |
|---|---|---|---|---|
| Releukofilgrastim | Filgrastim 300 ug/mL | Injection, SolutionIntravenous, Subcutaneous | Amneal Pharmaceuticals LLC | 70121-1569 |
| Releukofilgrastim | Filgrastim 480 ug/.8mL | Injection, SolutionIntravenous, Subcutaneous | Amneal Pharmaceuticals LLC | 70121-1570 |
| Releukofilgrastim | Filgrastim 480 ug/1.6mL | Injection, SolutionIntravenous, Subcutaneous | Amneal Pharmaceuticals LLC | 70121-1571 |