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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

  • ndc11
    8438111001
    1 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

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