PRUCALOPRIDE

Orange BookUNIISPLATC A06AX05

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

Identification

ManufacturerSKG Pharma Inc.

CountryUS (United States)

ATC codeA06AX05

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
8308500530
30 TABLET, FILM COATED in 1 BOTTLE (83085-005-30)

Annotations

UNII (FDA Substance ID)

4V2G75E1CK

PRUCALOPRIDE SUCCINATE

RxCUI 2107309

Orange Book

A218812

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": "83085-005_25c68e03-9af5-47da-95ce-ca870a8b531f",
  "productndc": "83085-005",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "218812",
    "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": "ANDA218812",
  "marketing_category": "ANDA",
  "nonproprietary_name": "PRUCALOPRIDE",
  "start_marketing_date": "20250624",
  "active_numerator_strength": "1"
}

Related drugs

Other records sharing ATC code A06AX05.

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