Prucalopride

Orange BookUNIISPLATC A06AX05

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerHikma Pharmaceuticals USA Inc

CountryUS (United States)

ATC codeA06AX05

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0054074913
30 TABLET, FILM COATED in 1 BOTTLE (0054-0749-13)

Annotations

UNII (FDA Substance ID)

4V2G75E1CK

PRUCALOPRIDE SUCCINATE

RxCUI 2107309

Orange Book

A217662

ABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "4V2G75E1CK",
    "rxcui": "2107309",
    "inchikey": "QZRSNVSQLGRAID-UHFFFAOYSA-N",
    "display_name": "PRUCALOPRIDE SUCCINATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "af559917-802b-486c-9f7b-b770115acac8": {
      "match": "brand_token",
      "title": "PRUCALOPRIDE TABLET, FILM COATED [VIONA PHARMACEUTICALS INC]",
      "spl_version": "1",
      "published_date": "2026-02-02"
    }
  },
  "productid": "0054-0749_e912e1b4-48aa-472d-b6c4-d1f769cff5e2",
  "productndc": "0054-0749",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "217662",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 1MG BASE",
        "product_no": "001",
        "approval_date": "Jun 24, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 2MG BASE",
        "product_no": "002",
        "approval_date": "Jun 24, 2025"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PRUCALOPRIDE SUCCINATE",
  "proprietary_name": "Prucalopride",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA217662",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Prucalopride",
  "start_marketing_date": "20250624",
  "active_numerator_strength": "1"
}

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