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United States · US · US:53041-690_9cfdb214-1075-4449-9a01-f04cf5d0edfe

Diatrizoate Meglumine and Diatrizoate Sodium

Orange BookUNIISPL

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerGuardian Drug Company
CountryUS (United States)
ATC code
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    5304169003
    120 mL in 1 BOTTLE, GLASS (53041-690-03)
  • ndc11
    5304169009
    30 mL in 1 BOTTLE, GLASS (53041-690-09)

Annotations

UNII (FDA Substance ID)
3X9MR4N98U
DIATRIZOATE MEGLUMINE
RxCUI 3320
Orange Book
A214201
AA
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": "ORAL; RECTAL",
  "spl_meta": {
    "a216a7d5-3c28-482b-956a-93ae146e3763": {
      "match": "brand_token",
      "title": "DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM (DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM) SOLUTION [CAMBER PHARMACEUTICALS, INC.]",
      "spl_version": "3",
      "published_date": "2025-02-21"
    }
  },
  "productid": "53041-690_9cfdb214-1075-4449-9a01-f04cf5d0edfe",
  "productndc": "53041-690",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "214201",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "66%;10%",
        "product_no": "001",
        "approval_date": "Jun 27, 2022"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM",
  "proprietary_name": "Diatrizoate Meglumine and Diatrizoate Sodium",
  "active_ingred_unit": "mg/mL; mg/mL",
  "application_number": "ANDA214201",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Diatrizoate Meglumine and Diatrizoate Sodium",
  "start_marketing_date": "20191218",
  "active_numerator_strength": "660; 100"
}

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