E-Z-Paque

Orange BookUNIISPL

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

Identification

ManufacturerE-Z-EM Canada Inc

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
3290918702
12 BOTTLE, PLASTIC in 1 CARTON (32909-187-02) / 355 mL in 1 BOTTLE, PLASTIC

Annotations

UNII (FDA Substance ID)

25BB7EKE2E

BARIUM SULFATE

RxCUI 1331

Orange Book

N208143

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "25BB7EKE2E",
    "rxcui": "1331",
    "inchikey": "TZCXTZWJZNENPQ-UHFFFAOYSA-L",
    "display_name": "BARIUM SULFATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "2ecea1ab-66c8-4eb0-8503-6d6b41b51328": {
      "match": "brand_token",
      "title": "E-Z-PAQUE (BARIUM SULFATE) SUSPENSION [E-Z-EM CANADA INC]",
      "spl_version": "8",
      "published_date": "2026-05-04"
    }
  },
  "productid": "32909-187_46aedc5a-3192-4fc2-abbd-ad76d4cab960",
  "productndc": "32909-187",
  "dosage_form": "SUSPENSION",
  "orange_book": {
    "appl_no": "208143",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "2%",
        "product_no": "001",
        "approval_date": "Jan 15, 2016"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "2%",
        "product_no": "002",
        "approval_date": "Jan 15, 2016"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "60%",
        "product_no": "003",
        "approval_date": "Mar 1, 2017"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "40%",
        "product_no": "004",
        "approval_date": "Jul 7, 2017"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "40%",
        "product_no": "005",
        "approval_date": "Aug 4, 2017"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "40%",
        "product_no": "006",
        "approval_date": "Jan 23, 2018"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "40%",
        "product_no": "007",
        "approval_date": "Mar 26, 2018"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "24%",
        "product_no": "008",
        "approval_date": "May 29, 2020"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BARIUM SULFATE",
  "proprietary_name": "E-Z-Paque",
  "active_ingred_unit": "g/mL",
  "application_number": "NDA208143",
  "marketing_category": "NDA",
  "nonproprietary_name": "barium sulfate",
  "start_marketing_date": "20201101",
  "active_numerator_strength": ".6"
}

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