parsabiv

Generic: etelcalcetide

Labeler: amgen inc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name parsabiv
Generic Name etelcalcetide
Labeler amgen inc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

etelcalcetide hydrochloride 5 mg/mL

Manufacturer
Amgen Inc

Identifiers & Regulatory

Product NDC 55513-741
Product ID 55513-741_d5c8bf18-7600-425a-adff-ea29f3db2f6c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA208325
Listing Expiration 2026-12-31
Marketing Start 2017-04-03

Pharmacologic Class

Classes
calcium-sensing receptor agonist [epc] increased calcium-sensing receptor sensitivity [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 55513741
Hyphenated Format 55513-741

Supplemental Identifiers

RxCUI
1876127 1876132 1876135 1876136 1876137 1876138
UPC
0355513742108 0355513740104 0355513741101
UNII
72PT5993DU

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 parsabiv (source: ndc)
Generic Name etelcalcetide (source: ndc)
Application Number NDA208325 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 10 VIAL, SINGLE-DOSE in 1 CARTON (55513-741-10) / 1 mL in 1 VIAL, SINGLE-DOSE (55513-741-01)
  • 10 VIAL, SINGLE-DOSE in 1 CARTON (55513-741-20) / 1 mL in 1 VIAL, SINGLE-DOSE (55513-741-01)
source: ndc

Packages (2)

55513-741-10 10 VIAL, SINGLE-DOSE in 1 CARTON (55513-741-10) / 1 mL in 1 VIAL, SINGLE-DOSE (55513-741-01) 55513-741-20 10 VIAL, SINGLE-DOSE in 1 CARTON (55513-741-20) / 1 mL in 1 VIAL, SINGLE-DOSE (55513-741-01)

Ingredients (1)

etelcalcetide hydrochloride (5 mg/mL)

Linked Drug Pages (1)

PARSABIV ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "d5c8bf18-7600-425a-adff-ea29f3db2f6c", "openfda": {"upc": ["0355513742108", "0355513740104", "0355513741101"], "unii": ["72PT5993DU"], "rxcui": ["1876127", "1876132", "1876135", "1876136", "1876137", "1876138"], "spl_set_id": ["cd270093-c6a8-4596-a4ab-e6aa0a2c8a0c"], "manufacturer_name": ["Amgen Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 CARTON (55513-741-10)  / 1 mL in 1 VIAL, SINGLE-DOSE (55513-741-01)", "package_ndc": "55513-741-10", "marketing_start_date": "20170403"}, {"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 CARTON (55513-741-20)  / 1 mL in 1 VIAL, SINGLE-DOSE (55513-741-01)", "package_ndc": "55513-741-20", "marketing_start_date": "20250801"}], "brand_name": "PARSABIV", "product_id": "55513-741_d5c8bf18-7600-425a-adff-ea29f3db2f6c", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Calcium-sensing Receptor Agonist [EPC]", "Increased Calcium-sensing Receptor Sensitivity [MoA]"], "product_ndc": "55513-741", "generic_name": "etelcalcetide", "labeler_name": "Amgen Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PARSABIV", "active_ingredients": [{"name": "ETELCALCETIDE HYDROCHLORIDE", "strength": "5 mg/mL"}], "application_number": "NDA208325", "marketing_category": "NDA", "marketing_start_date": "20170403", "listing_expiration_date": "20261231"}