🇺🇸
United States · US · US:0024-1596_7e15f87d-f34f-4ec2-9da8-a041db792623
Primaquine Phosphate
Orange BookUNIISPLATC P01BA03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSanofi-Aventis U.S. LLC
CountryUS (United States)
ATC codeP01BA03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 0
No packs registered.
Annotations
UNII (FDA Substance ID)
H0982HF78B
PRIMAQUINE PHOSPHATE
RxCUI 8689
Orange Book
N008316
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "H0982HF78B",
"rxcui": "8689",
"inchikey": "GJOHLWZHWQUKAU-UHFFFAOYSA-N",
"display_name": "PRIMAQUINE PHOSPHATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"3f16166d-678e-51aa-e054-00144ff88e88": {
"match": "brand_token",
"title": "PRIMAQUINE PHOSPHATE TABLET [PD-RX PHARMACEUTICALS, INC.]",
"spl_version": "12",
"published_date": "2026-05-13"
}
},
"productid": "0024-1596_7e15f87d-f34f-4ec2-9da8-a041db792623",
"productndc": "0024-1596",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "008316",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "EQ 15MG BASE",
"product_no": "001",
"approval_date": "Approved Prior to Jan 1, 1982"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "PRIMAQUINE PHOSPHATE",
"proprietary_name": "Primaquine Phosphate",
"active_ingred_unit": "mg/1",
"application_number": "NDA008316",
"marketing_category": "NDA",
"nonproprietary_name": "Primaquine Phosphate",
"start_marketing_date": "20110415",
"active_numerator_strength": "15"
}Related drugs
Other records sharing ATC code P01BA03.
- CZPRIMAQUINE
- CAPRIMAQUINESANOFI-AVENTIS CANADA INC
- GBPrimaquine 15mg tabletsImported (United States)
- GBPrimaquine 2.5mg/5ml oral suspensionSpecial Order
- GBPrimaquine 7.5mg tabletsSpecial Order
- 🇺🇸Primaquine PhosphatePD-Rx Pharmaceuticals, Inc.
- 🇺🇸Primaquine PhosphateUnichem Pharmaceuticals (USA), Inc.
- 🇺🇸PRIMAQUINE PHOSPHATEAvKARE
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