Prescription drug · BLA
Nplate (Romiplostim) NDC 55513-221
Romiplostim 250 ug/.5mL · Injection, Powder, Lyophilized, For solution · Subcutaneous · Amgen, Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55513-221-01 | 5551302210155513022101 | 1 VIAL in 1 CARTON (55513-221-01) / .5 mL in 1 VIALMarketed from Aug 25, 2008 | |
| 55513-221-21 | 5551302212155513022121 | 1 VIAL in 1 CARTON (55513-221-21) / .5 mL in 1 VIALMarketed from Aug 1, 2025 |
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)
- Nplate
- Generic name (nonproprietary)
- romiplostim
- Active ingredients
- Romiplostim — 250 ug/.5mL
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Subcutaneous
- Labeler
- Amgen, IncNDC labeler code 55513
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 125268
- Marketing start
- Listing expires
- Other FDA classes
- Increased Megakaryocyte Maturation (Physiologic effect)Increased Platelet Production (Physiologic effect)Thrombopoietin Receptor Agonists (Mechanism)
- Identifiers
- Product ID 55513-221_7f47b815-d08b-46fe-aee9-d2cef6e86ec0SPL ID 7f47b815-d08b-46fe-aee9-d2cef6e86ec0SPL set ID c45f9a58-37c1-4f76-8e36-97d38c577037RxCUI 1728092, 1728095, 1728097, 1728099, 2201538, 2201540UNII GN5XU2DXKVUPC 0355513221016, 0355513222013
- Pharmacologic class
- Thrombopoietin Receptor Agonist
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
N455513022101followed by a unit qualifier and the quantityPackage 55513-0221-01. 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)
Nplate is a thrombopoietin receptor agonist indicated for the treatment of thrombocytopenia in: Adult patients with immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. ( 1.1 ) Pediatric patients 1 year of age and older with ITP for at least 6 months who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. ( 1.1 ) Nplate is indicated to increase survival in adults and in pediatric patients (including term neonates) acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome [HS-ARS]). ( 1.2 ) Limitations of Use: Nplate is not indicated for the t…
Excerpt only. Read the full label for complete information.
About NDC 55513-221
- What is NDC 55513-221?
- 55513-221 is the product NDC for Nplate (romiplostim), Romiplostim 250 ug/.5mL injection, powder, lyophilized, for solution, listed with the FDA by Amgen, Inc. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Nplate (Romiplostim).
- What is the active ingredient?
- Romiplostim.
- 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 Nplate?
- 2 other product NDCs are listed under this name. See all Nplate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Nplate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Nplateromiplostim | Romiplostim 125 ug/.25mL | Injection, Powder, Lyophilized, For solutionSubcutaneous | Amgen, Inc | 55513-223 | 55513-0223-0155513-0223-21 |
| Nplateromiplostim | Romiplostim 500 ug/mL | Injection, Powder, Lyophilized, For solutionSubcutaneous | Amgen, Inc | 55513-222 | 55513-0222-0155513-0222-21 |
Other NDCs under BLA 125268
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 |
|---|---|---|---|---|
| Nplateromiplostim | Romiplostim 500 ug/mL | Injection, Powder, Lyophilized, For solutionSubcutaneous | Amgen, Inc | 55513-222 |
| Nplateromiplostim | Romiplostim 125 ug/.25mL | Injection, Powder, Lyophilized, For solutionSubcutaneous | Amgen, Inc | 55513-223 |