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United States · US · US:83649-330_c7c0666e-57ea-45e4-b3b4-e3950a173011

Daraprim

Orange BookUNIISPLATC P01BD01

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

Identification

ManufacturerTILDE Sciences LLC
CountryUS (United States)
ATC codeP01BD01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    8364933001
    100 TABLET in 1 BOTTLE, PLASTIC (83649-330-01)
  • ndc11
    8364933003
    30 TABLET in 1 BOTTLE, PLASTIC (83649-330-03)

Annotations

UNII (FDA Substance ID)
Z3614QOX8W
PYRIMETHAMINE
RxCUI 9010
Orange Book
N008578
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "Z3614QOX8W",
    "rxcui": "9010",
    "inchikey": "WKSAUQYGYAYLPV-UHFFFAOYSA-N",
    "display_name": "PYRIMETHAMINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "f634f34b-0952-4dd3-9da3-f84b6ab823de": {
      "match": "brand_token",
      "title": "DARAPRIM (PYRIMETHAMINE) TABLET [TILDE SCIENCES LLC]",
      "spl_version": "1",
      "published_date": "2023-12-11"
    }
  },
  "productid": "83649-330_c7c0666e-57ea-45e4-b3b4-e3950a173011",
  "productndc": "83649-330",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "008578",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "25MG",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PYRIMETHAMINE",
  "proprietary_name": "Daraprim",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA008578",
  "marketing_category": "NDA",
  "nonproprietary_name": "pyrimethamine",
  "start_marketing_date": "19530123",
  "active_numerator_strength": "25"
}

Related drugs

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