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United States · US · US:80830-2468_ff93b085-67bb-4fef-b6b7-37dd845171e7
Iohexol
Orange BookUNIISPLATC V08AB02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAmneal Pharmaceuticals Private Limited
CountryUS (United States)
ATC codeV08AB02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11808302468210 BOTTLE, PLASTIC in 1 CARTON (80830-2468-2) / 100 mL in 1 BOTTLE, PLASTIC (80830-2468-1)
Annotations
UNII (FDA Substance ID)
4419T9MX03
IOHEXOL
RxCUI 5956
Orange Book
A217737
AP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "4419T9MX03",
"rxcui": "5956",
"inchikey": "NTHXOOBQLCIOLC-UHFFFAOYSA-N",
"display_name": "IOHEXOL",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRA-ARTICULAR; INTRATHECAL; INTRAVASCULAR; INTRAVENOUS; ORAL; RECTAL",
"spl_meta": {
"ff9456ef-c45a-450d-9004-a684af2bcc59": {
"match": "brand_token",
"title": "IOHEXOL INJECTION, SOLUTION [AMNEAL PHARMACEUTICALS PRIVATE LIMITED]",
"spl_version": "9",
"published_date": "2026-05-13"
}
},
"productid": "80830-2468_ff93b085-67bb-4fef-b6b7-37dd845171e7",
"productndc": "80830-2468",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "217737",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "64.7%",
"product_no": "001",
"approval_date": "Nov 13, 2025"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "IOHEXOL",
"proprietary_name": "Iohexol",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA217737",
"marketing_category": "ANDA",
"nonproprietary_name": "Iohexol",
"start_marketing_date": "20251113",
"active_numerator_strength": "300"
}Related drugs
Other records sharing ATC code V08AB02.
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