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United States · US · US:84381-110_506ca7d0-9794-a2c5-e063-6394a90aeead
RAPIBLYK
Orange BookUNIISPLATC C07AB14
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAOP Orphan Pharmaceuticals GmbH
CountryUS (United States)
ATC codeC07AB14
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1184381110011 VIAL, SINGLE-DOSE in 1 CARTON (84381-110-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE
Annotations
UNII (FDA Substance ID)
G8HQ634Y17
LANDIOLOL HYDROCHLORIDE
Orange Book
N217202
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "G8HQ634Y17",
"rxcui": null,
"inchikey": "DLPGJHSONYLBKP-IKGOIYPNSA-N",
"display_name": "LANDIOLOL HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS",
"spl_meta": {
"27e7f20f-78a4-f1a9-e063-6394a90ae465": {
"match": "brand_token",
"title": "RAPIBLYK (LANDIOLOL) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [AOP ORPHAN PHARMACEUTICALS GMBH]",
"spl_version": "106",
"published_date": "2026-04-30"
}
},
"productid": "84381-110_506ca7d0-9794-a2c5-e063-6394a90aeead",
"productndc": "84381-110",
"dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"orange_book": {
"appl_no": "217202",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 280MG BASE/VIAL",
"product_no": "001",
"approval_date": "Nov 22, 2024"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "LANDIOLOL HYDROCHLORIDE",
"proprietary_name": "RAPIBLYK",
"active_ingred_unit": "mg/1",
"application_number": "NDA217202",
"marketing_category": "NDA",
"nonproprietary_name": "landiolol",
"start_marketing_date": "20250807",
"active_numerator_strength": "280"
}Related drugs
Other records sharing ATC code C07AB14.
- NLLandiolol Hydrochloride Orpha-Devel 300 mg poeder voor oplossing voor infusieOrpha Devel Handels-und Vertriebs GmbH
- DKRapiblocAmomed Pharma GmbH
- DKRapiblocAmomed Pharma GmbH
- FIRapiblocAmomed Pharma GmbH
- FIRapiblocAmomed Pharma GmbH
- FIRapiblocAmomed Pharma GmbH
- CZRAPIBLOCAmomed Pharma GmbH, Vídeň
- CZRAPIBLOCAmomed Pharma GmbH, Vídeň
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