Fulphila (pegfilgrastim-jmdb) NDC 83257-005 · J-Code J2506

NDC codes

FDA NDC Directory

Product NDC (as listed)83257-005Labeler and product segments. Claims need a package NDC.

Product NDC at billing width83257-0005Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
83257-005-41	83257000541	1 SYRINGE in 1 CARTON (83257-005-41) / .6 mL in 1 SYRINGEMarketed from Oct 1, 2023

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): Fulphila
Generic name (nonproprietary): pegfilgrastim-jmdb
Active ingredients: Pegfilgrastim — 6 mg/.6mL
Dosage form: Injection
Route: Subcutaneous
Labeler: Biocon Biologics Inc.
Product type: Prescription drug
Marketing category: BLA — Biologics License ApplicationApplication BLA 761075
Marketing start: Oct 1, 2023
Listing expires: Dec 31, 2027
Other FDA classes: Granulocyte Colony-Stimulating Factor (Chemical structure)Increased Myeloid Cell Production (Physiologic effect)
Identifiers: Product ID 83257-005_d060dfe4-0d02-2d02-34f3-c31bfff5ab7aSPL ID d060dfe4-0d02-2d02-34f3-c31bfff5ab7aSPL set ID 9bfc4d3e-6120-7fec-f1d6-0b3743752034RxCUI 2048020, 2048025UNII 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.

How CPT relates to drug billing

NDC on a medical claim

N483257000541 followed by a unit qualifier and the quantity

Package 83257-0005-41. 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 Jan 30, 2026.

Indications (excerpt from the label)

Fulphila 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 ) Limitations of Use Fulphila is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. 1.1 Patients with Cancer Receiving Myelosuppressive Chemotherapy Fulphila is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs as…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)