Prescription drug · BLA

Aranesp (darbepoetin alfa) NDC 55513-002

Darbepoetin alfa 25 ug/mL · Solution · Intravenous, Subcutaneous · Amgen, Inc

NDC codes

FDA NDC Directory
Product NDC (as listed)55513-002Labeler and product segments. Claims need a package NDC.
Product NDC at billing width55513-0002Add 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 NDC11-digit (billing)PackageCopy
55513-002-04555130002044 VIAL, SINGLE-DOSE in 1 PACKAGE (55513-002-04) / 1 mL in 1 VIAL, SINGLE-DOSE (55513-002-01)Marketed from Sep 11, 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/mL
Dosage form
Solution
Route
Intravenous, Subcutaneous
Labeler
Amgen, Inc
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 55513-002_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

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.

How CPT relates to drug billing

NDC on a medical claim

N455513000204 followed by a unit qualifier and the quantity

Package 55513-0002-04. 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.

Full label on DailyMed (opens in a new tab)

Other NDCs under BLA 103951

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under BLA 103951
ProductStrengthForm · routeLabelerProduct NDC
Aranespdarbepoetin alfaDarbepoetin alfa 40 ug/mLSolutionIntravenous, SubcutaneousAmgen, Inc55513-003
Aranespdarbepoetin alfaDarbepoetin alfa 60 ug/mLSolutionIntravenous, SubcutaneousAmgen, Inc55513-004
Aranespdarbepoetin alfaDarbepoetin alfa 100 ug/mLSolutionIntravenous, SubcutaneousAmgen, Inc55513-005
Aranespdarbepoetin alfaDarbepoetin alfa 100 ug/.5mLInjection, SolutionIntravenous, SubcutaneousAmgen, Inc55513-025
Aranespdarbepoetin alfaDarbepoetin alfa 200 ug/mLSolutionIntravenous, SubcutaneousAmgen, Inc55513-006
Aranespdarbepoetin alfaDarbepoetin alfa 40 ug/.4mLInjection, SolutionIntravenous, SubcutaneousAmgen, Inc55513-021
Aranespdarbepoetin alfaDarbepoetin alfa 60 ug/.3mLInjection, SolutionIntravenous, SubcutaneousAmgen, Inc55513-023
Aranespdarbepoetin alfaDarbepoetin alfa 150 ug/.3mLInjection, SolutionIntravenous, SubcutaneousAmgen, Inc55513-027
Aranespdarbepoetin alfaDarbepoetin alfa 200 ug/.4mLInjection, SolutionIntravenous, SubcutaneousAmgen, Inc55513-028
Aranespdarbepoetin alfaDarbepoetin alfa 500 ug/mLInjection, SolutionIntravenous, SubcutaneousAmgen, Inc55513-032
Aranespdarbepoetin alfaDarbepoetin alfa 25 ug/.42mLInjection, SolutionIntravenous, SubcutaneousAmgen, Inc55513-057
Aranespdarbepoetin alfaDarbepoetin alfa 10 ug/.4mLInjection, SolutionIntravenous, SubcutaneousAmgen, Inc55513-098
Aranespdarbepoetin alfaDarbepoetin alfa 300 ug/.6mLInjection, SolutionIntravenous, SubcutaneousAmgen, Inc55513-111

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Aranesp (darbepoetin alfa) NDC 55513-002 | Med-Code