Prucalopride

Orange BookUNIISPLATC A06AX05

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

Identification

ManufacturerAjanta Pharma USA Inc.

CountryUS (United States)

ATC codeA06AX05

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
2724129430
30 TABLET in 1 BOTTLE (27241-294-30)

Annotations

UNII (FDA Substance ID)

0A09IUW5TP

PRUCALOPRIDE

RxCUI 2107310

Orange Book

A219220

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": "27241-294_ac2afe93-a78a-4dfe-8759-fec53f872e35",
  "productndc": "27241-294",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "219220",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 1MG BASE",
        "product_no": "001",
        "approval_date": "Jan 16, 2026"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 2MG BASE",
        "product_no": "002",
        "approval_date": "Jan 16, 2026"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PRUCALOPRIDE",
  "proprietary_name": "Prucalopride",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA219220",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Prucalopride",
  "start_marketing_date": "20260116",
  "active_numerator_strength": "1"
}

Related drugs

Other records sharing ATC code A06AX05.

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