Prescription drug · BLA
Fylnetra (pegfilgrastim) NDC 70121-1627
Pegfilgrastim 6 mg/.6mL · Injection · Subcutaneous · Amneal Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70121-1627-1 | 70121162701 | 1 SYRINGE in 1 CARTON (70121-1627-1) / .6 mL in 1 SYRINGEMarketed from May 31, 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)
- Fylnetra
- Generic name (nonproprietary)
- pegfilgrastim
- Active ingredients
- Pegfilgrastim — 6 mg/.6mL
- Dosage form
- Injection
- Route
- Subcutaneous
- Labeler
- Amneal Pharmaceuticals LLC
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761084
- Marketing start
- Listing expires
- Other FDA classes
- Granulocyte Colony-Stimulating Factor (Chemical structure)Increased Myeloid Cell Production (Physiologic effect)
- Identifiers
- Product ID 70121-1627_8cb6cfed-487e-4351-8f48-0be3cc5c2d6dSPL ID 8cb6cfed-487e-4351-8f48-0be3cc5c2d6dSPL set ID eeadd641-573d-47fe-897a-61006e5f9e03RxCUI 2602781, 2602787UNII 3A58010674UPC 0370121162711, 0470121162718
- 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 codeMed-Code curated
J2506 — Injection, pegfilgrastim, excludes biosimilar, 0.5 mg
Billing unit: 0.5 mg. Units on the claim = dose given ÷ 0.5 mg.
Pegfilgrastim biosimilars have their own HCPCS codes.
- 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
N470121162701followed by a unit qualifier and the quantityPackage 70121-1627-01. 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)
FYLNETRA is a leukocyte growth factor indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. (1.1) Increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome). (1.2) Limitations of Use FYLNETRA is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. 1.1 Patients with Cancer Receiving Myelosuppressive Chemotherapy FYLNETRA is indicated to decrease the inciden…
Excerpt only. Read the full label for complete information.