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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

  • ndc11
    7638510201
    100 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"
}

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