aranesp

Generic: darbepoetin alfa

Labeler: amgen, inc
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name aranesp
Generic Name darbepoetin alfa
Labeler amgen, inc
Dosage Form SOLUTION
Routes
INTRAVENOUS SUBCUTANEOUS
Active Ingredients

darbepoetin alfa 40 ug/mL

Manufacturer
Amgen, Inc

Identifiers & Regulatory

Product NDC 55513-003
Product ID 55513-003_7023e5d7-0f00-4fa4-8223-fa77bee46feb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA103951
Listing Expiration 2027-12-31
Marketing Start 2006-09-11

Pharmacologic Class

Established (EPC)
erythropoiesis-stimulating agent [epc]
Chemical Structure
erythropoietin [cs]
Physiologic Effect
increased erythroid cell production [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 55513003
Hyphenated Format 55513-003

Supplemental Identifiers

UPC
0355513006019
UNII
15UQ94PT4P
NUI
N0000175665 M0007726 N0000009319

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name aranesp (source: ndc)
Generic Name darbepoetin alfa (source: ndc)
Application Number BLA103951 (source: ndc)
Routes
INTRAVENOUS SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 40 ug/mL
source: ndc
Packaging
  • 4 VIAL, SINGLE-DOSE in 1 PACKAGE (55513-003-04) / 1 mL in 1 VIAL, SINGLE-DOSE (55513-003-01)
source: ndc

Packages (1)

55513-003-04 4 VIAL, SINGLE-DOSE in 1 PACKAGE (55513-003-04) / 1 mL in 1 VIAL, SINGLE-DOSE (55513-003-01)

Ingredients (1)

darbepoetin alfa (40 ug/mL)

Linked Drug Pages (1)

ARANESP ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS", "SUBCUTANEOUS"], "spl_id": "7023e5d7-0f00-4fa4-8223-fa77bee46feb", "openfda": {"nui": ["N0000175665", "M0007726", "N0000009319"], "upc": ["0355513006019"], "unii": ["15UQ94PT4P"], "spl_set_id": ["0fd36cb9-c4f6-4167-93c9-8530865db3f9"], "pharm_class_cs": ["Erythropoietin [CS]"], "pharm_class_pe": ["Increased Erythroid Cell Production [PE]"], "pharm_class_epc": ["Erythropoiesis-stimulating Agent [EPC]"], "manufacturer_name": ["Amgen, Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "4 VIAL, SINGLE-DOSE in 1 PACKAGE (55513-003-04)  / 1 mL in 1 VIAL, SINGLE-DOSE (55513-003-01)", "package_ndc": "55513-003-04", "marketing_start_date": "20060911"}], "brand_name": "ARANESP", "product_id": "55513-003_7023e5d7-0f00-4fa4-8223-fa77bee46feb", "dosage_form": "SOLUTION", "pharm_class": ["Erythropoiesis-stimulating Agent [EPC]", "Erythropoietin [CS]", "Increased Erythroid Cell Production [PE]"], "product_ndc": "55513-003", "generic_name": "darbepoetin alfa", "labeler_name": "Amgen, Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ARANESP", "active_ingredients": [{"name": "DARBEPOETIN ALFA", "strength": "40 ug/mL"}], "application_number": "BLA103951", "marketing_category": "BLA", "marketing_start_date": "20060911", "listing_expiration_date": "20271231"}