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United States · US · US:43063-721_51a584d0-f172-e260-e063-6394a90a4547

Primaquine Phosphate

Orange BookUNIISPLATC P01BA03

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerPD-Rx Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeP01BA03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    4306372114
    14 TABLET in 1 BOTTLE, PLASTIC (43063-721-14)
  • ndc11
    4306372128
    28 TABLET in 1 BOTTLE, PLASTIC (43063-721-28)

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": "43063-721_51a584d0-f172-e260-e063-6394a90a4547",
  "productndc": "43063-721",
  "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.

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