Prucalopride

Orange BookUNIISPLATC A06AX05

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

Identification

ManufacturerANI Pharmaceuticals, Inc.

CountryUS (United States)

ATC codeA06AX05

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7095459610
30 TABLET in 1 BOTTLE (70954-596-10)

Annotations

UNII (FDA Substance ID)

4V2G75E1CK

PRUCALOPRIDE SUCCINATE

RxCUI 2107309

Orange Book

A218492

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": "70954-596_a33b876a-c96e-4f3d-a1b8-56c4daa46892",
  "productndc": "70954-596",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "218492",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 1MG BASE",
        "product_no": "001",
        "approval_date": "Dec 26, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 2MG BASE",
        "product_no": "002",
        "approval_date": "Dec 26, 2024"
      }
    ],
    "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": "ANDA218492",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Prucalopride",
  "start_marketing_date": "20241226",
  "active_numerator_strength": "1"
}

Related drugs

Other records sharing ATC code A06AX05.

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