Prescription drug · BLA
Neulasta (Pegfilgrastim) NDC 55513-192
Kit · Amgen, Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55513-192-01 | 5551301920155513019201 | 1 KIT in 1 CARTON (55513-192-01) * .6 mL in 1 SYRINGEMarketed from Feb 20, 2015 |
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)
- Neulasta
- Generic name (nonproprietary)
- pegfilgrastim
- Dosage form
- Kit
- Labeler
- Amgen, IncNDC labeler code 55513
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 125031
- Marketing start
- Listing expires
- Identifiers
- Product ID 55513-192_a090f981-1f1f-4a5b-adc7-31f1022c4748SPL ID a090f981-1f1f-4a5b-adc7-31f1022c4748SPL set ID fdfe5d72-6b80-435a-afa4-c5d74dd852ceRxCUI 727539, 727542, 2549331, 2549333, 2739503, 2739504UNII 3A58010674
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.
- NDC on a medical claim
N455513019201followed by a unit qualifier and the quantityPackage 55513-0192-01. 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)
Neulasta is a leukocyte growth factor indicated in adult and pediatric patients 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 Neulasta is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. 1.1 Patients with Cancer Receiving Myelosuppressive Chemotherapy Neulasta …
Excerpt only. Read the full label for complete information.
About NDC 55513-192
- What is NDC 55513-192?
- 55513-192 is the product NDC for Neulasta (pegfilgrastim) kit, listed with the FDA by Amgen, Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Neulasta (Pegfilgrastim).
- Who is the labeler?
- Amgen, Inc, NDC labeler code 55513. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Neulasta?
- 2 other product NDCs are listed under this name. See all Neulasta NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Neulasta products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Neulastapegfilgrastim | Pegfilgrastim 4 mg/.4mL | SolutionSubcutaneous | Amgen, Inc | 55513-099 | 55513-0099-01 |
| Neulastapegfilgrastim | Pegfilgrastim 6 mg/.6mL | InjectionSubcutaneous | Amgen, Inc | 55513-190 | 55513-0190-01 |
Other NDCs under BLA 125031
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 |
|---|---|---|---|---|
| Neulastapegfilgrastim | Pegfilgrastim 4 mg/.4mL | SolutionSubcutaneous | Amgen, Inc | 55513-099 |
| Neulastapegfilgrastim | Pegfilgrastim 6 mg/.6mL | InjectionSubcutaneous | Amgen, Inc | 55513-190 |