Prescription drug · BLA
Aranesp (Darbepoetin alfa) NDC 55513-057
Darbepoetin alfa 25 ug/.42mL · Injection, Solution · Intravenous, Subcutaneous · Amgen, Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55513-057-04 | 5551300570455513005704 | 1 BLISTER PACK in 1 PACKAGE (55513-057-04) / 4 SYRINGE in 1 BLISTER PACK / .42 mL in 1 SYRINGE (55513-057-01)Marketed from Aug 26, 2006 |
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)
- Aranesp
- Generic name (nonproprietary)
- darbepoetin alfa
- Active ingredients
- Darbepoetin alfa — 25 ug/.42mL
- Dosage form
- Injection, Solution
- Route
- Intravenous, Subcutaneous
- Labeler
- Amgen, IncNDC labeler code 55513
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 103951
- Marketing start
- Listing expires
- Other FDA classes
- Erythropoietin (Chemical structure)Increased Erythroid Cell Production (Physiologic effect)
- Identifiers
- Product ID 55513-057_2f0f60a5-832a-4954-ba26-7dec84fcf4f3SPL ID 2f0f60a5-832a-4954-ba26-7dec84fcf4f3SPL set ID 0fd36cb9-c4f6-4167-93c9-8530865db3f9RxCUI 349273, 349274, 349275, 349276, 352044, 352045, 352046, 352047, 730044, 730046, 731167, 731171, 731174, 731176, 731179, 731181, 731184, 731227, 731229, 731231, 731235, 731241, 731245, 731250, 1605171, 1605172, 1654954, 1654955UNII 15UQ94PT4PUPC 0355513006217
- Pharmacologic class
- Erythropoiesis-stimulating Agent
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
N455513005704followed by a unit qualifier and the quantityPackage 55513-0057-04. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
Aranesp is an erythropoiesis-stimulating agent (ESA) indicated for the treatment of anemia due to: Chronic Kidney Disease (CKD) in patients on dialysis and patients not on dialysis ( 1.1 ). The effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy ( 1.2 ). Limitations of Use Aranesp has not been shown to improve quality of life, fatigue, or patient well-being ( 1.3 ). Aranesp is not indicated for use: In patients with cancer receiving hormonal agents, biologic products, or radiotherapy, unless also receiving concomitant myelosuppressive chemotherapy ( 1.3 ). In patients with cancer receiving myelosuppres…
Excerpt only. Read the full label for complete information.
About NDC 55513-057
- What is NDC 55513-057?
- 55513-057 is the product NDC for Aranesp (darbepoetin alfa), Darbepoetin alfa 25 ug/.42mL injection, solution, 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?
- Aranesp (Darbepoetin alfa).
- What is the active ingredient?
- Darbepoetin alfa.
- 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 Aranesp?
- 13 other product NDCs are listed under this name. See all Aranesp NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Aranesp products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Aranespdarbepoetin alfa | Darbepoetin alfa 25 ug/mL | SolutionIntravenous, Subcutaneous | Amgen, Inc | 55513-002 | 55513-0002-04 |
| Aranespdarbepoetin alfa | Darbepoetin alfa 40 ug/mL | SolutionIntravenous, Subcutaneous | Amgen, Inc | 55513-003 | 55513-0003-04 |
| Aranespdarbepoetin alfa | Darbepoetin alfa 60 ug/mL | SolutionIntravenous, Subcutaneous | Amgen, Inc | 55513-004 | 55513-0004-04 |
| Aranespdarbepoetin alfa | Darbepoetin alfa 100 ug/mL | SolutionIntravenous, Subcutaneous | Amgen, Inc | 55513-005 | 55513-0005-04 |
| Aranespdarbepoetin alfa | Darbepoetin alfa 200 ug/mL | SolutionIntravenous, Subcutaneous | Amgen, Inc | 55513-006 | 55513-0006-0155513-0006-21 |
| Aranespdarbepoetin alfa | Darbepoetin alfa 150 ug/.3mL | Injection, SolutionIntravenous, Subcutaneous | Amgen, Inc | 55513-027 | 55513-0027-04 |
| Aranespdarbepoetin alfa | Darbepoetin alfa 10 ug/.4mL | Injection, SolutionIntravenous, Subcutaneous | Amgen, Inc | 55513-098 | 55513-0098-04 |
| Aranespdarbepoetin alfa | Darbepoetin alfa 40 ug/.4mL | Injection, SolutionIntravenous, Subcutaneous | Amgen, Inc | 55513-021 | 55513-0021-04 |
| Aranespdarbepoetin alfa | Darbepoetin alfa 60 ug/.3mL | Injection, SolutionIntravenous, Subcutaneous | Amgen, Inc | 55513-023 | 55513-0023-04 |
| Aranespdarbepoetin alfa | Darbepoetin alfa 100 ug/.5mL | Injection, SolutionIntravenous, Subcutaneous | Amgen, Inc | 55513-025 | 55513-0025-04 |
Other NDCs under BLA 103951
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 |
|---|---|---|---|---|
| Aranespdarbepoetin alfa | Darbepoetin alfa 60 ug/mL | SolutionIntravenous, Subcutaneous | Amgen, Inc | 55513-004 |
| Aranespdarbepoetin alfa | Darbepoetin alfa 25 ug/mL | SolutionIntravenous, Subcutaneous | Amgen, Inc | 55513-002 |
| Aranespdarbepoetin alfa | Darbepoetin alfa 40 ug/mL | SolutionIntravenous, Subcutaneous | Amgen, Inc | 55513-003 |
| Aranespdarbepoetin alfa | Darbepoetin alfa 60 ug/.3mL | Injection, SolutionIntravenous, Subcutaneous | Amgen, Inc | 55513-023 |
| Aranespdarbepoetin alfa | Darbepoetin alfa 100 ug/mL | SolutionIntravenous, Subcutaneous | Amgen, Inc | 55513-005 |
| Aranespdarbepoetin alfa | Darbepoetin alfa 200 ug/mL | SolutionIntravenous, Subcutaneous | Amgen, Inc | 55513-006 |
| Aranespdarbepoetin alfa | Darbepoetin alfa 40 ug/.4mL | Injection, SolutionIntravenous, Subcutaneous | Amgen, Inc | 55513-021 |
| Aranespdarbepoetin alfa | Darbepoetin alfa 200 ug/.4mL | Injection, SolutionIntravenous, Subcutaneous | Amgen, Inc | 55513-028 |
| Aranespdarbepoetin alfa | Darbepoetin alfa 100 ug/.5mL | Injection, SolutionIntravenous, Subcutaneous | Amgen, Inc | 55513-025 |
| Aranespdarbepoetin alfa | Darbepoetin alfa 150 ug/.3mL | Injection, SolutionIntravenous, Subcutaneous | Amgen, Inc | 55513-027 |
| Aranespdarbepoetin alfa | Darbepoetin alfa 500 ug/mL | Injection, SolutionIntravenous, Subcutaneous | Amgen, Inc | 55513-032 |
| Aranespdarbepoetin alfa | Darbepoetin alfa 10 ug/.4mL | Injection, SolutionIntravenous, Subcutaneous | Amgen, Inc | 55513-098 |
| Aranespdarbepoetin alfa | Darbepoetin alfa 300 ug/.6mL | Injection, SolutionIntravenous, Subcutaneous | Amgen, Inc | 55513-111 |