🇺🇸
United States · US · US:69413-330_ca65359c-029c-44f4-ba89-c4058ddd4e30
Daraprim
Orange BookUNIISPLATC P01BD01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerVyera Pharmaceuticals LLC
CountryUS (United States)
ATC codeP01BD01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc116941333010100 TABLET in 1 BOTTLE, PLASTIC (69413-330-10)
- ndc11694133303030 TABLET in 1 BOTTLE, PLASTIC (69413-330-30)
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": "69413-330_ca65359c-029c-44f4-ba89-c4058ddd4e30",
"productndc": "69413-330",
"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
Other records sharing ATC code P01BD01.
- 🇺🇸DaraprimTILDE Sciences LLC
- NODaraprimGlaxoSmithKline
- FIDaraprimThe Wellcome Foundation Limited
- 🇨🇭DaraprimGlaxoSmithKline AG
- BEDaraprim 25 mgGlaxoSmithKline Pharmaceuticals
- 🇪🇸DARAPRIM 25 mg COMPRIMIDOSSmithkline Beecham Farma S.A.
- NLDaraprim 25 mg tablettenGlaxoSmithKline B.V.
- GBDaraprim 25mg tabletsGlaxoSmithKline UK Ltd
Access this data programmatically
Query Daraprim and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.