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United States · US · US:76385-102_8199ccba-1a57-43f1-bbdc-70b6720b72c3
Primaquine Phosphate
Orange BookUNIISPLATC P01BA03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerUnichem Pharmaceuticals (USA), Inc.
CountryUS (United States)
ATC codeP01BA03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc117638510201100 TABLET in 1 BOTTLE (76385-102-01)
Annotations
UNII (FDA Substance ID)
H0982HF78B
PRIMAQUINE PHOSPHATE
RxCUI 8689
Orange Book
A204476
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": "76385-102_8199ccba-1a57-43f1-bbdc-70b6720b72c3",
"productndc": "76385-102",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "204476",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 15MG BASE",
"product_no": "001",
"approval_date": "Feb 25, 2014"
}
],
"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": "ANDA204476",
"marketing_category": "ANDA",
"nonproprietary_name": "Primaquine Phosphate",
"start_marketing_date": "20140801",
"active_numerator_strength": "15"
}Related drugs
Other records sharing ATC code P01BA03.
- CZPRIMAQUINE
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- GBPrimaquine 15mg tabletsImported (United States)
- GBPrimaquine 2.5mg/5ml oral suspensionSpecial Order
- GBPrimaquine 7.5mg tabletsSpecial Order
- 🇺🇸Primaquine PhosphateSanofi-Aventis U.S. LLC
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- 🇺🇸PRIMAQUINE PHOSPHATEAvKARE
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