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United States · US · US:65219-381_1980ecbd-58c9-4176-af7f-af955bb0ad2e

Iodixanol

Orange BookUNIIATC V08AB09

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

Identification

ManufacturerFRESENIUS KABI USA, LLC
CountryUS (United States)
ATC codeV08AB09
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    6521938110
    10 BOTTLE, PLASTIC in 1 BOX (65219-381-10) / 100 mL in 1 BOTTLE, PLASTIC (65219-381-03)
  • ndc11
    6521938150
    10 BOTTLE, PLASTIC in 1 BOX (65219-381-50) / 150 mL in 1 BOTTLE, PLASTIC (65219-381-05)

Annotations

UNII (FDA Substance ID)
HW8W27HTXX
IODIXANOL
RxCUI 27729
Orange Book
A214271
APAP
Raw payload (JSON)
{
  "unii": {
    "unii": "HW8W27HTXX",
    "rxcui": "27729",
    "inchikey": "NBQNWMBBSKPBAY-UHFFFAOYSA-N",
    "display_name": "IODIXANOL",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVASCULAR",
  "productid": "65219-381_1980ecbd-58c9-4176-af7f-af955bb0ad2e",
  "productndc": "65219-381",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "214271",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "55%",
        "product_no": "001",
        "approval_date": "May 19, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "65.2%",
        "product_no": "002",
        "approval_date": "May 19, 2022"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "IODIXANOL",
  "proprietary_name": "Iodixanol",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA214271",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Iodixanol",
  "start_marketing_date": "20220621",
  "active_numerator_strength": "270"
}

Related drugs

Other records sharing ATC code V08AB09.

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