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United States · US · US:67253-651_99a1da9d-39dd-4fc1-8470-c486e5c8b850
Propylthiouracil
Orange BookUNIISPLATC H03BA02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerEndo USA, Inc.
CountryUS (United States)
ATC codeH03BA02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc116725365110100 TABLET in 1 BOTTLE (67253-651-10)
- ndc1167253651111000 TABLET in 1 BOTTLE (67253-651-11)
Annotations
UNII (FDA Substance ID)
721M9407IY
PROPYLTHIOURACIL
RxCUI 8794
Orange Book
N006188
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "721M9407IY",
"rxcui": "8794",
"inchikey": "KNAHARQHSZJURB-UHFFFAOYSA-N",
"display_name": "PROPYLTHIOURACIL",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"804fa92a-a5ba-4be0-aa44-a40a2e89fde6": {
"match": "brand_token",
"title": "PROPYLTHIOURACIL TABLET [TEVA PHARMACEUTICALS, INC.]",
"spl_version": "4",
"published_date": "2025-11-17"
}
},
"productid": "67253-651_99a1da9d-39dd-4fc1-8470-c486e5c8b850",
"productndc": "67253-651",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "006188",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "50MG",
"product_no": "001",
"approval_date": "Approved Prior to Jan 1, 1982"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "PROPYLTHIOURACIL",
"proprietary_name": "Propylthiouracil",
"active_ingred_unit": "mg/1",
"application_number": "NDA006188",
"marketing_category": "NDA",
"nonproprietary_name": "Propylthiouracil",
"start_marketing_date": "19470728",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code H03BA02.
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