Cystografin

Orange BookUNIISPLATC V08AA01

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

Identification

ManufacturerBRACCO DIAGNOSTICS INC

CountryUS (United States)

ATC codeV08AA01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
0270014957
10 BOTTLE in 1 PACKAGE (0270-0149-57) / 300 mL in 1 BOTTLE
ndc11
0270014960
10 BOTTLE in 1 PACKAGE (0270-0149-60) / 100 mL in 1 BOTTLE

Annotations

UNII (FDA Substance ID)

3X9MR4N98U

DIATRIZOATE MEGLUMINE

RxCUI 3320

Orange Book

N010040

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "3X9MR4N98U",
    "rxcui": "3320",
    "inchikey": "MIKKOBKEXMRYFQ-WZTVWXICSA-N",
    "display_name": "DIATRIZOATE MEGLUMINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "7496d736-9f7d-4136-ad5d-b24c7803c21b": {
      "match": "brand_token",
      "title": "CYSTOGRAFIN (DIATRIZOATE MEGLUMINE) INJECTION, SOLUTION [BRACCO DIAGNOSTICS INC]",
      "spl_version": "7",
      "published_date": "2025-12-03"
    }
  },
  "productid": "0270-0149_6b067ea9-50b4-0ec7-1f1c-e07b00faced4",
  "productndc": "0270-0149",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "010040",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "66%;10%",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "52%;8%",
        "product_no": "006",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "30%",
        "product_no": "012",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "60%",
        "product_no": "016",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "76%",
        "product_no": "017",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "30%",
        "product_no": "018",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "28.5%;29.1%",
        "product_no": "019",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "34.3%;35%",
        "product_no": "020",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "30%",
        "product_no": "021",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "18%",
        "product_no": "022",
        "approval_date": "Nov 9, 1982"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DIATRIZOATE MEGLUMINE",
  "proprietary_name": "Cystografin",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA010040",
  "marketing_category": "NDA",
  "nonproprietary_name": "diatrizoate meglumine",
  "start_marketing_date": "19701103",
  "active_numerator_strength": "300"
}

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