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United States · US · US:0480-9242_0c10d860-d116-4178-9ea5-8c067f2c4c26

Propylthiouracil

Orange BookUNIISPLATC H03BA02

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerTeva Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeH03BA02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0480924201
    100 TABLET in 1 BOTTLE (0480-9242-01)

Annotations

UNII (FDA Substance ID)
721M9407IY
PROPYLTHIOURACIL
RxCUI 8794
Orange Book
A080172
BD
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": "0480-9242_0c10d860-d116-4178-9ea5-8c067f2c4c26",
  "productndc": "0480-9242",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "080172",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "BD",
        "strength": "50MG",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PROPYLTHIOURACIL",
  "proprietary_name": "Propylthiouracil",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA080172",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Propylthiouracil",
  "start_marketing_date": "20240710",
  "active_numerator_strength": "50"
}

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