Prescription drug · BLA
Nyvepria (pegfilgrastim-apgf) NDC 0069-0324
Pegfilgrastim 6 mg/.6mL · Injection, Solution · Subcutaneous · Pfizer Laboratories Div Pfizer Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0069-0324-01 | 00069032401 | 1 CARTON in 1 CARTON (0069-0324-01) / 1 SYRINGE in 1 CARTON / .6 mL in 1 SYRINGEMarketed from Dec 15, 2020 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Nyvepria
- Generic name (nonproprietary)
- pegfilgrastim-apgf
- Active ingredients
- Pegfilgrastim — 6 mg/.6mL
- Dosage form
- Injection, Solution
- Route
- Subcutaneous
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761111
- Marketing start
- Listing expires
- Other FDA classes
- Granulocyte Colony-Stimulating Factor (Chemical structure)Increased Myeloid Cell Production (Physiologic effect)
- Identifiers
- Product ID 0069-0324_e562b389-581e-4cf2-a09d-0bd6093d9027SPL ID e562b389-581e-4cf2-a09d-0bd6093d9027SPL set ID 99d30b99-2743-446b-98f3-0430bf4ea869RxCUI 2469335, 2469340UNII 3A58010674
- 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
N400069032401followed by a unit qualifier and the quantityPackage 00069-0324-01. 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)
Patients with Cancer Receiving Myelosuppressive Chemotherapy NYVEPRIA is indicated in adults and pediatric patients aged newborn and older 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 [see Dosage and Administration (2.1) and Clinical Studies (14) ] . NYVEPRIA is a leukocyte growth factor indicated in adults and pediatric patients aged newborn and older to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti…
Excerpt only. Read the full label for complete information.
- Source
- FDA NDC Directory via openFDA; FDA SPL via openFDA and DailyMed; Med-Code HCPCS directory (curated)
- openFDA data updated
Med-Code stores this record for up to 24 hours before requesting it again.
Reference information only. Verify codes and billing rules against the applicable payer and official source before submitting a claim. How Med-Code handles data.