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United States · US · US:55513-740_52286976-a97a-4b77-b678-f40ab5aa7133
PARSABIV
Orange BookUNIISPLATC H05BX04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAmgen, Inc
CountryUS (United States)
ATC codeH05BX04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11555137401010 VIAL, SINGLE-DOSE in 1 CARTON (55513-740-10) / .5 mL in 1 VIAL, SINGLE-DOSE (55513-740-01)
- ndc11555137402010 VIAL, SINGLE-DOSE in 1 CARTON (55513-740-20) / .5 mL in 1 VIAL, SINGLE-DOSE (55513-740-01)
Annotations
UNII (FDA Substance ID)
72PT5993DU
ETELCALCETIDE HYDROCHLORIDE
RxCUI 1876122
Orange Book
N208325
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "72PT5993DU",
"rxcui": "1876122",
"inchikey": "KHQMSZGKHGQUHG-WZDHWKSBSA-N",
"display_name": "ETELCALCETIDE HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS",
"spl_meta": {
"cd270093-c6a8-4596-a4ab-e6aa0a2c8a0c": {
"match": "brand_token",
"title": "PARSABIV (ETELCALCETIDE) INJECTION, SOLUTION [AMGEN, INC]",
"spl_version": "15",
"published_date": "2026-03-16"
}
},
"productid": "55513-740_52286976-a97a-4b77-b678-f40ab5aa7133",
"productndc": "55513-740",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "208325",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "2.5MG/0.5ML (2.5MG/0.5ML)",
"product_no": "001",
"approval_date": "Feb 7, 2017"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "5MG/ML (5MG/ML)",
"product_no": "002",
"approval_date": "Feb 7, 2017"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "10MG/2ML (5MG/ML)",
"product_no": "003",
"approval_date": "Feb 7, 2017"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ETELCALCETIDE HYDROCHLORIDE",
"proprietary_name": "PARSABIV",
"active_ingred_unit": "mg/.5mL",
"application_number": "NDA208325",
"marketing_category": "NDA",
"nonproprietary_name": "etelcalcetide",
"start_marketing_date": "20170403",
"active_numerator_strength": "2.5"
}Related drugs
Other records sharing ATC code H05BX04.
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