pyrimethamine

Generic: pyrimethamine

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name pyrimethamine
Generic Name pyrimethamine
Labeler aurobindo pharma limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

pyrimethamine 25 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 59651-590
Product ID 59651-590_3214e53b-6abb-4a20-b849-0558e79dac05
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216983
Listing Expiration 2026-12-31
Marketing Start 2022-10-25

Pharmacologic Class

Established (EPC)
dihydrofolate reductase inhibitor antimalarial [epc]
Mechanism of Action
dihydrofolate reductase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59651590
Hyphenated Format 59651-590

Supplemental Identifiers

RxCUI
198182
UPC
0359651590300
UNII
Z3614QOX8W
NUI
N0000175934 N0000000191

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 pyrimethamine (source: ndc)
Generic Name pyrimethamine (source: ndc)
Application Number ANDA216983 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (59651-590-01)
  • 30 TABLET in 1 BOTTLE (59651-590-30)
source: ndc

Packages (2)

59651-590-01 100 TABLET in 1 BOTTLE (59651-590-01) 59651-590-30 30 TABLET in 1 BOTTLE (59651-590-30)

Ingredients (1)

pyrimethamine (25 mg/1)

Linked Drug Pages (1)

Pyrimethamine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3214e53b-6abb-4a20-b849-0558e79dac05", "openfda": {"nui": ["N0000175934", "N0000000191"], "upc": ["0359651590300"], "unii": ["Z3614QOX8W"], "rxcui": ["198182"], "spl_set_id": ["7aca002e-a538-4715-9121-a17bdb7f200c"], "pharm_class_epc": ["Dihydrofolate Reductase Inhibitor Antimalarial [EPC]"], "pharm_class_moa": ["Dihydrofolate Reductase Inhibitors [MoA]"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (59651-590-01)", "package_ndc": "59651-590-01", "marketing_start_date": "20221025"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (59651-590-30)", "package_ndc": "59651-590-30", "marketing_start_date": "20221025"}], "brand_name": "Pyrimethamine", "product_id": "59651-590_3214e53b-6abb-4a20-b849-0558e79dac05", "dosage_form": "TABLET", "pharm_class": ["Dihydrofolate Reductase Inhibitor Antimalarial [EPC]", "Dihydrofolate Reductase Inhibitors [MoA]"], "product_ndc": "59651-590", "generic_name": "Pyrimethamine", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Pyrimethamine", "active_ingredients": [{"name": "PYRIMETHAMINE", "strength": "25 mg/1"}], "application_number": "ANDA216983", "marketing_category": "ANDA", "marketing_start_date": "20221025", "listing_expiration_date": "20261231"}