NDC 55513-740

PARSABIV

Etelcalcetide

PARSABIV is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Amgen Inc. The primary component is Etelcalcetide Hydrochloride.

• Product ID: 55513-740_012ce6ec-5707-49fa-9e39-6932948c2283
• NDC: 55513-740
• Product Type: Human Prescription Drug
• Proprietary Name: PARSABIV
• Generic Name: Etelcalcetide
• Dosage Form: Injection, Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2017-04-03
• Marketing Category: NDA / NDA
• Application Number: NDA208325
• Labeler Name: Amgen Inc
• Substance Name: ETELCALCETIDE HYDROCHLORIDE
• Active Ingredient Strength: 3 mg/.5mL
• Pharm Classes: Calcium-sensing Receptor Agonist [EPC],Increased Calcium-sensing Receptor Sensitivity [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 55513-740-10

10 VIAL, SINGLE-DOSE in 1 CARTON (55513-740-10) > .5 mL in 1 VIAL, SINGLE-DOSE (55513-740-01)

• Marketing Start Date: 2017-04-03
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 55513-740-10 [55513074010]

PARSABIV INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA208325
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2017-04-03

NDC 55513-740-01 [55513074001]

PARSABIV INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA208325
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2017-04-03

Drug Details

Active Ingredients

Ingredient	Strength
ETELCALCETIDE HYDROCHLORIDE	2.5 mg/.5mL

OpenFDA Data

• SPL SET ID: cd270093-c6a8-4596-a4ab-e6aa0a2c8a0c
• Manufacturer:
  • Amgen Inc
• UNII:
  • 72PT5993DU
• RxNorm Concept Unique ID - RxCUI:
  • 1876138
  • 1876132
  • 1876137
  • 1876136
  • 1876135
  • 1876127
• UPC Code:
  • 0355513741101
  • 0355513740104
  • 0355513742108

Pharmacological Class

• Calcium-sensing Receptor Agonist [EPC]
• Increased Calcium-sensing Receptor Sensitivity [MoA]

NDC Crossover Matching brand name "PARSABIV" or generic name "Etelcalcetide"

NDC	Brand Name	Generic Name
55513-740	PARSABIV	etelcalcetide
55513-741	PARSABIV	etelcalcetide
55513-742	PARSABIV	etelcalcetide