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United States · US · US:50633-910_4628b109-7ff2-cbf5-e063-6294a90a7933
ThyroSafe
In shortageOrange BookUNIISPLATC R05CA02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBTG International Inc.
CountryUS (United States)
ATC codeR05CA02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc115063391020160 BOX in 1 CARTON (50633-910-20) / 20 BLISTER PACK in 1 BOX / 1 TABLET in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
1C4QK22F9J
POTASSIUM IODIDE
RxCUI 8597
Orange Book
A076350
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Potassium Citrate Tablet, Extended Release
Raw payload (JSON)
{
"unii": {
"unii": "1C4QK22F9J",
"rxcui": "8597",
"inchikey": "NLKNQRATVPKPDG-UHFFFAOYSA-M",
"display_name": "POTASSIUM IODIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"30387dc3-da14-1964-e063-6394a90afa4e": {
"match": "brand_token",
"title": "THYROSAFE (POTASSIUM IODIDE) TABLET [BTG INTERNATIONAL INC]",
"spl_version": "1",
"published_date": "2026-02-12"
}
},
"productid": "50633-910_4628b109-7ff2-cbf5-e063-6294a90a7933",
"productndc": "50633-910",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "076350",
"products": [
{
"rs": true,
"rld": false,
"te_code": null,
"strength": "65MG",
"product_no": "001",
"approval_date": "Sep 10, 2002"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "130MG",
"product_no": "002",
"approval_date": "Apr 2, 2025"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "POTASSIUM IODIDE",
"shortage_reason": "Potassium Citrate Tablet, Extended Release",
"shortage_status": "current",
"proprietary_name": "ThyroSafe",
"active_ingred_unit": "mg/1",
"application_number": "ANDA076350",
"marketing_category": "ANDA",
"nonproprietary_name": "Potassium Iodide",
"start_marketing_date": "20020930",
"active_numerator_strength": "65"
}Related drugs
Other records sharing ATC code R05CA02.
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