🇺🇸
United States · US · US:42291-510_4ba945a5-47a2-e791-e063-6294a90a9f8a
PRIMAQUINE PHOSPHATE
Orange BookUNIISPLATC P01BA03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAvKARE
CountryUS (United States)
ATC codeP01BA03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc114229151001100 TABLET, FILM COATED in 1 BOTTLE (42291-510-01)
Annotations
UNII (FDA Substance ID)
H0982HF78B
PRIMAQUINE PHOSPHATE
RxCUI 8689
Orange Book
A206043
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": "42291-510_4ba945a5-47a2-e791-e063-6294a90a9f8a",
"productndc": "42291-510",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "206043",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 15MG BASE",
"product_no": "001",
"approval_date": "Jun 23, 2016"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "PRIMAQUINE PHOSPHATE",
"proprietary_name": "PRIMAQUINE PHOSPHATE",
"active_ingred_unit": "mg/1",
"application_number": "ANDA206043",
"marketing_category": "ANDA",
"nonproprietary_name": "PRIMAQUINE PHOSPHATE",
"start_marketing_date": "20190221",
"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 PhosphateUnichem Pharmaceuticals (USA), Inc.
- 🇺🇸Primaquine PhosphateSanofi-Aventis U.S. LLC
- 🇺🇸Primaquine PhosphatePD-Rx Pharmaceuticals, Inc.
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