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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

  • ndc11
    3334231411
    100 TABLET in 1 BOTTLE (33342-314-11)
  • ndc11
    3334231412
    10 BLISTER PACK in 1 CARTON (33342-314-12) / 10 TABLET in 1 BLISTER PACK
  • ndc11
    3334231444
    1000 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

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