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United States · US · US:50419-747_c9ab40f0-8a11-486f-be88-765af55b6484

Biltricide

Orange BookUNIISPLATC P02BA01

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerBayer HealthCare Pharmaceuticals Inc.
CountryUS (United States)
ATC codeP02BA01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5041974701
    6 TABLET, FILM COATED in 1 BOTTLE (50419-747-01)

Annotations

UNII (FDA Substance ID)
6490C9U457
PRAZIQUANTEL
RxCUI 8628
Orange Book
N018714
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "6490C9U457",
    "rxcui": "8628",
    "inchikey": "FSVJFNAIGNNGKK-UHFFFAOYSA-N",
    "display_name": "PRAZIQUANTEL",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "34ce1cdd-648e-4f1e-8512-bf3d4cc22eb9": {
      "match": "brand_token",
      "title": "BILTRICIDE (PRAZIQUANTEL) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.]",
      "spl_version": "13",
      "published_date": "2026-03-04"
    }
  },
  "productid": "50419-747_c9ab40f0-8a11-486f-be88-765af55b6484",
  "productndc": "50419-747",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "018714",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "600MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "001",
        "approval_date": "Dec 29, 1982"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PRAZIQUANTEL",
  "proprietary_name": "Biltricide",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA018714",
  "marketing_category": "NDA",
  "nonproprietary_name": "praziquantel",
  "start_marketing_date": "20110421",
  "active_numerator_strength": "600"
}

Related drugs

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