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United States · US · US:33342-314_7e848dc9-0f07-4dd1-8aa6-a64558a1ddb8
Propylthiouracil
Orange BookUNIISPLATC H03BA02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMacleods Pharmaceuticals Limited
CountryUS (United States)
ATC codeH03BA02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc113334231411100 TABLET in 1 BOTTLE (33342-314-11)
- ndc11333423141210 BLISTER PACK in 1 CARTON (33342-314-12) / 10 TABLET in 1 BLISTER PACK
- ndc1133342314441000 TABLET in 1 BOTTLE (33342-314-44)
Annotations
UNII (FDA Substance ID)
721M9407IY
PROPYLTHIOURACIL
RxCUI 8794
Orange Book
A208867
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": "33342-314_7e848dc9-0f07-4dd1-8aa6-a64558a1ddb8",
"productndc": "33342-314",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "208867",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "50MG",
"product_no": "001",
"approval_date": "May 10, 2023"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "PROPYLTHIOURACIL",
"proprietary_name": "Propylthiouracil",
"active_ingred_unit": "mg/1",
"application_number": "ANDA208867",
"marketing_category": "ANDA",
"nonproprietary_name": "Propylthiouracil",
"start_marketing_date": "20230510",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code H03BA02.
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