primaquine phosphate

Generic: primaquine phosphate

Labeler: unichem pharmaceuticals (usa), inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name primaquine phosphate
Generic Name primaquine phosphate
Labeler unichem pharmaceuticals (usa), inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

primaquine phosphate 15 mg/1

Manufacturer
Unichem Pharmaceuticals (USA), Inc.

Identifiers & Regulatory

Product NDC 76385-102
Product ID 76385-102_8199ccba-1a57-43f1-bbdc-70b6720b72c3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204476
Listing Expiration 2027-12-31
Marketing Start 2014-08-01

Pharmacologic Class

Classes
antimalarial [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76385102
Hyphenated Format 76385-102

Supplemental Identifiers

RxCUI
904170
UPC
0376385102012
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 ANDA204476 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 15 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (76385-102-01)
source: ndc

Packages (1)

76385-102-01 100 TABLET in 1 BOTTLE (76385-102-01)

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": "8199ccba-1a57-43f1-bbdc-70b6720b72c3", "openfda": {"upc": ["0376385102012"], "unii": ["H0982HF78B"], "rxcui": ["904170"], "spl_set_id": ["0c8c2bc6-428b-40b6-8114-6df80290878d"], "manufacturer_name": ["Unichem Pharmaceuticals (USA), Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (76385-102-01)", "package_ndc": "76385-102-01", "marketing_start_date": "20140801"}], "brand_name": "Primaquine Phosphate", "product_id": "76385-102_8199ccba-1a57-43f1-bbdc-70b6720b72c3", "dosage_form": "TABLET", "pharm_class": ["Antimalarial [EPC]"], "product_ndc": "76385-102", "generic_name": "Primaquine Phosphate", "labeler_name": "Unichem Pharmaceuticals (USA), 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": "20271231"}