🇺🇸
United States · US · US:59651-590_3214e53b-6abb-4a20-b849-0558e79dac05
Pyrimethamine
Orange BookUNIISPLATC P01BD01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAurobindo Pharma Limited
CountryUS (United States)
ATC codeP01BD01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc115965159001100 TABLET in 1 BOTTLE (59651-590-01)
- ndc11596515903030 TABLET in 1 BOTTLE (59651-590-30)
Annotations
UNII (FDA Substance ID)
Z3614QOX8W
PYRIMETHAMINE
RxCUI 9010
Orange Book
A216983
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": {
"fdeff3ed-e783-411a-8317-57e8b0e931e0": {
"match": "brand_token",
"title": "PYRIMETHAMINE TABLET [NORTHSTAR RX LLC]",
"spl_version": "2",
"published_date": "2025-04-23"
}
},
"productid": "59651-590_3214e53b-6abb-4a20-b849-0558e79dac05",
"productndc": "59651-590",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "216983",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "25MG",
"product_no": "001",
"approval_date": "Oct 25, 2022"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "PYRIMETHAMINE",
"proprietary_name": "Pyrimethamine",
"active_ingred_unit": "mg/1",
"application_number": "ANDA216983",
"marketing_category": "ANDA",
"nonproprietary_name": "Pyrimethamine",
"start_marketing_date": "20221025",
"active_numerator_strength": "25"
}Related drugs
Other records sharing ATC code P01BD01.
- 🇺🇸DaraprimVyera Pharmaceuticals LLC
- NODaraprimGlaxoSmithKline
- FIDaraprimThe Wellcome Foundation Limited
- 🇨🇭DaraprimGlaxoSmithKline AG
- 🇺🇸DaraprimTILDE Sciences LLC
- BEDaraprim 25 mgGlaxoSmithKline Pharmaceuticals
- 🇪🇸DARAPRIM 25 mg COMPRIMIDOSSmithkline Beecham Farma S.A.
- NLDaraprim 25 mg tablettenGlaxoSmithKline B.V.
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