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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
- ndc11652193811010 BOTTLE, PLASTIC in 1 BOX (65219-381-10) / 100 mL in 1 BOTTLE, PLASTIC (65219-381-03)
- ndc11652193815010 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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