NDC 55513-057

ARANESP

Darbepoetin Alfa

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

• Product ID: 55513-057_427e99b1-1e75-4e98-b61e-73f3ba905307
• NDC: 55513-057
• Product Type: Human Prescription Drug
• Proprietary Name: ARANESP
• Generic Name: Darbepoetin Alfa
• Dosage Form: Injection, Solution
• Route of Administration: INTRAVENOUS; SUBCUTANEOUS
• Marketing Start Date: 2006-08-26
• Marketing Category: BLA / BLA
• Application Number: BLA103951
• Labeler Name: Amgen Inc
• Substance Name: DARBEPOETIN ALFA
• Active Ingredient Strength: 25 ug/.42mL
• Pharm Classes: Erythropoiesis-stimulating Agent [EPC], Erythropoietin [CS], Increased Erythroid Cell Production [PE]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 55513-057-04

1 BLISTER PACK in 1 PACKAGE (55513-057-04) > 4 SYRINGE in 1 BLISTER PACK > .42 mL in 1 SYRINGE (55513-057-01)

• Marketing Start Date: 2006-08-26
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 55513-057-01 [55513005701]

ARANESP INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA103951
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2011-02-18

NDC 55513-057-04 [55513005704]

ARANESP INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA103951
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2006-08-26

Drug Details

Active Ingredients

Ingredient	Strength
DARBEPOETIN ALFA	25 ug/.42mL

OpenFDA Data

• SPL SET ID: 0fd36cb9-c4f6-4167-93c9-8530865db3f9
• Manufacturer:
  • Amgen Inc
• UNII:
  • 15UQ94PT4P
• 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"

NDC	Brand Name	Generic Name
55513-002	ARANESP	darbepoetin alfa
55513-003	ARANESP	darbepoetin alfa
55513-004	ARANESP	darbepoetin alfa
55513-005	ARANESP	darbepoetin alfa
55513-006	ARANESP	darbepoetin alfa
55513-021	ARANESP	darbepoetin alfa
55513-023	ARANESP	darbepoetin alfa
55513-025	ARANESP	darbepoetin alfa
55513-027	ARANESP	darbepoetin alfa
55513-028	ARANESP	darbepoetin alfa
55513-032	ARANESP	darbepoetin alfa
55513-057	ARANESP	darbepoetin alfa
55513-098	ARANESP	darbepoetin alfa
55513-110	ARANESP	darbepoetin alfa
55513-111	ARANESP	darbepoetin alfa