Prucalopride

Orange BookUNIISPLATC A06AX05

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

Identification

ManufacturerSpecGx LLC

CountryUS (United States)

ATC codeA06AX05

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0406630103
30 TABLET, FILM COATED in 1 BOTTLE (0406-6301-03)

Annotations

UNII (FDA Substance ID)

0A09IUW5TP

PRUCALOPRIDE

RxCUI 2107310

Orange Book

A219193

ABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "0A09IUW5TP",
    "rxcui": "2107310",
    "inchikey": "ZPMNHBXQOOVQJL-UHFFFAOYSA-N",
    "display_name": "PRUCALOPRIDE",
    "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": "0406-6301_ef151ce8-6bd9-4be8-9010-337ad85551b1",
  "productndc": "0406-6301",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "219193",
    "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",
  "proprietary_name": "Prucalopride",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA219193",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Prucalopride",
  "start_marketing_date": "20250624",
  "active_numerator_strength": "1"
}

Related drugs

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