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ARANESP

darbepoetin alfa · Solution

Prescription Biologic BLA
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
ARANESP
Generic name
darbepoetin alfa
Dosage form
Solution
Route
Intravenous
Marketing category
BLA · BLA
Labeler
Amgen, Inc
Product type
Human Prescription Drug
DEA schedule
Not scheduled
Active ingredients
5
NDC product codes
5
Packages
6
Data completeness
58% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Darbepoetin Alfa 100 ug/mL 349273 View
Darbepoetin Alfa 200 ug/mL 349273 View
Darbepoetin Alfa 25 ug/mL 349273 View
Darbepoetin Alfa 40 ug/mL 349273 View
Darbepoetin Alfa 60 ug/mL 349273 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Solution
Route of administration
Intravenous
Presentations
11

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class Type Browse
Erythropoiesis-stimulating Agent [EPC] EPC 6 members — no class page
Erythropoietin [CS] CS 6 members — no class page
Increased Erythroid Cell Production [PE] PE 7 members — no class page

Regulatory status

Source: Drugs@FDANDC Directory
Application number
103951
Application type
BLA · Biologics License Application
Approval date
September 17, 2001
Sponsor
AMGEN
Products on application
10
Submissions recorded
34
Products approved under application 103951.
Product Trade name Form Strength Ingredient Status TE Flags
103951-001 ARANESP VIAL DARBEPOETIN ALFA Prescription —
103951-002 ARANESP VIAL DARBEPOETIN ALFA Prescription —
103951-003 ARANESP VIAL DARBEPOETIN ALFA Prescription —
103951-004 ARANESP VIAL DARBEPOETIN ALFA Prescription —
103951-005 ARANESP VIAL DARBEPOETIN ALFA Prescription —
103951-006 ARANESP VIAL DARBEPOETIN ALFA Prescription —
103951-007 ARANESP VIAL DARBEPOETIN ALFA Prescription —
103951-008 ARANESP VIAL DARBEPOETIN ALFA Prescription —
103951-009 ARANESP VIAL DARBEPOETIN ALFA Prescription —
103951-010 ARANESP VIAL DARBEPOETIN ALFA Prescription —

Approval history

Source: Drugs@FDA
Most recent submissions on application 103951.
Type No. Action Status Date Review
Supplement 5383 Labeling Approved April 30, 2024 Standard
Supplement 5378 Efficacy Approved January 30, 2019 Priority
Supplement 5377 Labeling Approved December 20, 2018 Standard
Supplement 5374 Labeling Approved October 31, 2017 Standard
Supplement 5375 Labeling Approved April 13, 2017 Standard
Supplement 5370 Labeling Approved April 27, 2016 Standard
Supplement 5363 Efficacy Approved July 23, 2015 Standard
Supplement 5353 Labeling Approved April 17, 2014 —
Supplement 5349 Labeling Approved December 31, 2013 Standard
Supplement 5325 Labeling Approved December 31, 2013 Standard
Supplement 5337 Labeling Approved March 27, 2013 Standard
Supplement 5285 Labeling Approved May 31, 2012 Standard
Supplement 5258 Labeling Approved June 24, 2011 Standard
Supplement 5248 Labeling Approved June 24, 2011 Standard
Supplement 5173 Efficacy Approved June 24, 2011 Standard
Supplement 5197 Labeling Approved February 16, 2010 Standard
Supplement 5223 Labeling Approved January 11, 2010 Standard
Supplement 5211 Labeling Approved October 13, 2009 Standard
Supplement 5195 Labeling Approved November 19, 2008 Standard
Supplement 5111 Efficacy Approved May 5, 2008 Standard
Supplement 5170 Labeling Approved March 7, 2008 Standard
Supplement 5169 Labeling Approved December 17, 2007 Standard
Supplement 5154 Labeling Approved November 13, 2007 Standard
Supplement 5164 Labeling Approved November 8, 2007 Standard
Supplement 5135 Labeling Approved April 10, 2007 Standard
Supplement 5139 Labeling Approved March 9, 2007 Standard
Supplement 5097 Efficacy Approved March 23, 2006 Standard
Supplement 5088 Efficacy Approved December 15, 2005 Standard
Supplement 5096 Labeling Approved October 26, 2005 Standard
Supplement 5090 Labeling Approved March 24, 2005 Standard
Supplement 5069 Labeling Approved December 16, 2004 Standard
Supplement 5075 Labeling Approved November 18, 2004 Standard
Supplement 5001 Efficacy Approved July 19, 2002 Standard
Original application 1 Type 1 - New Molecular Entity Approved September 17, 2001 Standard

Review documents

  • 0 · Supplement · May 2, 2024
  • 0 · Supplement · May 1, 2024
  • 0 · Supplement · June 5, 2019
  • 0 · Supplement · February 13, 2019
  • 0 · Supplement · January 31, 2019
  • 0 · Supplement · December 21, 2018
  • 0 · Supplement · November 6, 2017
  • 0 · Supplement · October 31, 2017
  • 0 · Supplement · April 14, 2017
  • 0 · Supplement · April 14, 2017
  • 0 · Supplement · April 28, 2016
  • 0 · Supplement · July 24, 2015
  • 0 · Supplement · January 7, 2014
  • 0 · Supplement · January 7, 2014
  • 0 · Supplement · January 2, 2014
  • 0 · Supplement · January 2, 2014
  • 0 · Supplement · March 29, 2013
  • 0 · Supplement · July 16, 2012
  • 0 · Supplement · June 6, 2012
  • 0 · Supplement · June 4, 2012
  • 0 · Supplement · May 25, 2012
  • 0 · Supplement · December 2, 2011
  • 0 · Supplement · June 24, 2011
  • 0 · Supplement · June 24, 2011
  • 0 · Supplement · June 24, 2011
  • 0 · Supplement · June 24, 2011
  • 0 · Supplement · June 24, 2011
  • 0 · Supplement · April 28, 2011
  • 0 · Supplement · February 16, 2010
  • 0 · Supplement · February 16, 2010

Adverse event reports

Source: openFDA FAERS
53,590
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: DARBEPOETIN ALFA. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
55513-002-04 55513-002 Amgen, Inc 4 VIAL, SINGLE-DOSE in 1 PACKAGE (55513-002-04) / 1 mL in 1 VIAL, SINGLE-DOSE (55513-002-01) September 11, 2006
55513-003-04 55513-003 Amgen, Inc 4 VIAL, SINGLE-DOSE in 1 PACKAGE (55513-003-04) / 1 mL in 1 VIAL, SINGLE-DOSE (55513-003-01) September 11, 2006
55513-004-04 55513-004 Amgen, Inc 4 VIAL, SINGLE-DOSE in 1 PACKAGE (55513-004-04) / 1 mL in 1 VIAL, SINGLE-DOSE (55513-004-01) September 11, 2006
55513-005-04 55513-005 Amgen, Inc 4 VIAL, SINGLE-DOSE in 1 PACKAGE (55513-005-04) / 1 mL in 1 VIAL, SINGLE-DOSE (55513-005-01) September 11, 2006
55513-006-01 55513-006 Amgen, Inc 1 VIAL, SINGLE-DOSE in 1 PACKAGE (55513-006-01) / 1 mL in 1 VIAL, SINGLE-DOSE September 11, 2006
55513-006-21 55513-006 Amgen, Inc 1 VIAL, SINGLE-DOSE in 1 PACKAGE (55513-006-21) / 1 mL in 1 VIAL, SINGLE-DOSE July 1, 2025
55513-002 55513-002 Amgen, Inc — September 11, 2006
55513-003 55513-003 Amgen, Inc — September 11, 2006
55513-004 55513-004 Amgen, Inc — September 11, 2006
55513-005 55513-005 Amgen, Inc — September 11, 2006
55513-006 55513-006 Amgen, Inc — September 11, 2006

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
FAERS FDA Adverse event report counts
Purple Book FDA Biologic licence classification

Generated September 25, 2026 · 10 sections on this page.