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United States · US · US:69208-000_490fdcc0-a035-b6f8-e063-6394a90a28a5
Sodium Iodide I-131
Orange BookSPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerRadnostix, Inc.
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1169208000001 KIT in 1 BOX (69208-000-00) * 3 SOLUTION, CONCENTRATE in 1 VIAL, DISPENSING (69208-003-35) * 2 SOLUTION, CONCENTRATE in 1 VIAL, DISPENSING (69208-003-25) * 1 CARTON in 1 BOX / 2 BLISTER PACK in 1 CARTON / 10 CAPSULE in 1 BLISTER PACK * 1 SOLUTION, CONCENTRATE in 1 VIAL, DISPENSING (69208-003-15)
Annotations
Orange Book
A209166
AA
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"route": "ORAL",
"spl_meta": {
"52430b12-4d5f-d1e1-e063-6394a90abd64": {
"match": "brand_token",
"title": "SODIUM FLUORIDE RINSE LIQUID [ROCKLAND COSMETICS, INC.]",
"spl_version": "1",
"published_date": "2026-05-21"
}
},
"productid": "69208-000_490fdcc0-a035-b6f8-e063-6394a90a28a5",
"productndc": "69208-000",
"dosage_form": "KIT",
"orange_book": {
"appl_no": "209166",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "250-1000mCi",
"product_no": "001",
"approval_date": "Feb 5, 2020"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": null,
"proprietary_name": "Sodium Iodide I-131",
"active_ingred_unit": null,
"application_number": "ANDA209166",
"marketing_category": "ANDA",
"nonproprietary_name": "Sodium Iodide I-131",
"start_marketing_date": "20200316",
"active_numerator_strength": null
}Access this data programmatically
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