NDC 55513-005

ARANESP

Darbepoetin Alfa

ARANESP is a Intravenous; Subcutaneous Solution in the Human Prescription Drug category. It is labeled and distributed by Amgen Inc. The primary component is Darbepoetin Alfa.

Product ID55513-005_427e99b1-1e75-4e98-b61e-73f3ba905307
NDC55513-005
Product TypeHuman Prescription Drug
Proprietary NameARANESP
Generic NameDarbepoetin Alfa
Dosage FormSolution
Route of AdministrationINTRAVENOUS; SUBCUTANEOUS
Marketing Start Date2006-09-11
Marketing CategoryBLA / BLA
Application NumberBLA103951
Labeler NameAmgen Inc
Substance NameDARBEPOETIN ALFA
Active Ingredient Strength100 ug/mL
Pharm ClassesErythropoiesis-stimulating Agent [EPC], Erythropoietin [CS], Increased Erythroid Cell Production [PE]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 55513-005-04

4 VIAL, SINGLE-DOSE in 1 PACKAGE (55513-005-04) > 1 mL in 1 VIAL, SINGLE-DOSE (55513-005-01)
Marketing Start Date2006-09-11
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55513-005-04 [55513000504]

ARANESP SOLUTION
Marketing CategoryBLA
Application NumberBLA103951
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2006-09-11

NDC 55513-005-01 [55513000501]

ARANESP SOLUTION
Marketing CategoryBLA
Application NumberBLA103951
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2006-09-11

Drug Details

Active Ingredients

IngredientStrength
DARBEPOETIN ALFA100 ug/mL

OpenFDA Data

SPL SET ID:0fd36cb9-c4f6-4167-93c9-8530865db3f9
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 731167
  • 731231
  • 1654955
  • 1654954
  • 731235
  • 1654951
  • 1605172
  • 351247
  • 731250
  • 731184
  • 731181
  • 731179
  • 731171
  • 731176
  • 731174
  • 730044
  • 730046
  • 352262
  • 731229
  • 731227
  • 731245
  • 1654949
  • 731241
  • 1605171
  • 352044
  • 352045
  • 352046
  • 352047
  • 349273
  • 349276
  • 349275
  • 349274
    • UPC Code
  • 0355513057042
  • 0355513006019

    • Pharmacological Class

    • Erythropoiesis-stimulating Agent [EPC]
    • Erythropoietin [CS]
    • Increased Erythroid Cell Production [PE]

    NDC Crossover Matching brand name "ARANESP" or generic name "Darbepoetin Alfa"

    NDCBrand NameGeneric Name
    55513-002ARANESPdarbepoetin alfa
    55513-003ARANESPdarbepoetin alfa
    55513-004ARANESPdarbepoetin alfa
    55513-005ARANESPdarbepoetin alfa
    55513-006ARANESPdarbepoetin alfa
    55513-021ARANESPdarbepoetin alfa
    55513-023ARANESPdarbepoetin alfa
    55513-025ARANESPdarbepoetin alfa
    55513-027ARANESPdarbepoetin alfa
    55513-028ARANESPdarbepoetin alfa
    55513-032ARANESPdarbepoetin alfa
    55513-057ARANESPdarbepoetin alfa
    55513-098ARANESPdarbepoetin alfa
    55513-110ARANESPdarbepoetin alfa
    55513-111ARANESPdarbepoetin alfa

    Trademark Results [ARANESP]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ARANESP
    ARANESP
    75849800 2607924 Live/Registered
    Amgen Inc.
    1999-11-16
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