primaquine phosphate

Generic: primaquine phosphate

Labeler: ingenus pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name primaquine phosphate
Generic Name primaquine phosphate
Labeler ingenus pharmaceuticals, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

primaquine phosphate 15 mg/1

Manufacturer
Ingenus Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 50742-191
Product ID 50742-191_0fb59114-6477-4616-88ab-48fdc00858f0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206043
Listing Expiration 2026-12-31
Marketing Start 2018-01-23

Pharmacologic Class

Classes
antimalarial [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50742191
Hyphenated Format 50742-191

Supplemental Identifiers

RxCUI
904170
UPC
0350742191055
UNII
H0982HF78B

Packaging Origin

Original Packager
true

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 ANDA206043 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 15 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50742-191-01)
  • 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50742-191-05)
source: ndc

Packages (2)

50742-191-01 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50742-191-01) 50742-191-05 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50742-191-05)

Ingredients (1)

primaquine phosphate (15 mg/1)

Linked Drug Pages (1)

PRIMAQUINE PHOSPHATE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "0fb59114-6477-4616-88ab-48fdc00858f0", "openfda": {"upc": ["0350742191055"], "unii": ["H0982HF78B"], "rxcui": ["904170"], "spl_set_id": ["09531382-2e06-4164-a7e1-169a1488788a"], "manufacturer_name": ["Ingenus Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50742-191-01)", "package_ndc": "50742-191-01", "marketing_start_date": "20180123"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50742-191-05)", "package_ndc": "50742-191-05", "marketing_start_date": "20180123"}], "brand_name": "PRIMAQUINE PHOSPHATE", "product_id": "50742-191_0fb59114-6477-4616-88ab-48fdc00858f0", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Antimalarial [EPC]"], "product_ndc": "50742-191", "generic_name": "PRIMAQUINE PHOSPHATE", "labeler_name": "Ingenus Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PRIMAQUINE PHOSPHATE", "active_ingredients": [{"name": "PRIMAQUINE PHOSPHATE", "strength": "15 mg/1"}], "application_number": "ANDA206043", "marketing_category": "ANDA", "marketing_start_date": "20180123", "listing_expiration_date": "20261231"}