primaquine phosphate

Generic: primaquine phosphate

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name primaquine phosphate
Generic Name primaquine phosphate
Labeler pd-rx pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

primaquine phosphate 15 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 43063-721
Product ID 43063-721_36c0e266-7161-2887-e063-6294a90a9fc1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204476
Listing Expiration 2026-12-31
Marketing Start 2014-08-01

Pharmacologic Class

Classes
antimalarial [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43063721
Hyphenated Format 43063-721

Supplemental Identifiers

RxCUI
904170
UPC
0343063721285
UNII
H0982HF78B

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name primaquine phosphate (source: ndc)
Generic Name primaquine phosphate (source: ndc)
Application Number ANDA204476 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 15 mg/1
source: ndc
Packaging
  • 14 TABLET in 1 BOTTLE, PLASTIC (43063-721-14)
  • 28 TABLET in 1 BOTTLE, PLASTIC (43063-721-28)
source: ndc

Packages (2)

Ingredients (1)

primaquine phosphate (15 mg/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "36c0e266-7161-2887-e063-6294a90a9fc1", "openfda": {"upc": ["0343063721285"], "unii": ["H0982HF78B"], "rxcui": ["904170"], "spl_set_id": ["3f16166d-678e-51aa-e054-00144ff88e88"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "14 TABLET in 1 BOTTLE, PLASTIC (43063-721-14)", "package_ndc": "43063-721-14", "marketing_start_date": "20161017"}, {"sample": false, "description": "28 TABLET in 1 BOTTLE, PLASTIC (43063-721-28)", "package_ndc": "43063-721-28", "marketing_start_date": "20161017"}], "brand_name": "Primaquine Phosphate", "product_id": "43063-721_36c0e266-7161-2887-e063-6294a90a9fc1", "dosage_form": "TABLET", "pharm_class": ["Antimalarial [EPC]"], "product_ndc": "43063-721", "generic_name": "Primaquine Phosphate", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Primaquine Phosphate", "active_ingredients": [{"name": "PRIMAQUINE PHOSPHATE", "strength": "15 mg/1"}], "application_number": "ANDA204476", "marketing_category": "ANDA", "marketing_start_date": "20140801", "listing_expiration_date": "20261231"}