daraprim

Generic: pyrimethamine

Labeler: tilde sciences llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name daraprim
Generic Name pyrimethamine
Labeler tilde sciences llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

pyrimethamine 25 mg/1

Manufacturer
TILDE Sciences LLC

Identifiers & Regulatory

Product NDC 83649-330
Product ID 83649-330_c7c0666e-57ea-45e4-b3b4-e3950a173011
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA008578
Listing Expiration 2026-12-31
Marketing Start 1953-01-23

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 83649330
Hyphenated Format 83649-330

Supplemental Identifiers

RxCUI
198182 201912
UPC
0383649330012 0383649330036
UNII
Z3614QOX8W
NUI
N0000175934 N0000000191

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 daraprim (source: ndc)
Generic Name pyrimethamine (source: ndc)
Application Number NDA008578 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE, PLASTIC (83649-330-01)
  • 30 TABLET in 1 BOTTLE, PLASTIC (83649-330-03)
source: ndc

Packages (2)

83649-330-01 100 TABLET in 1 BOTTLE, PLASTIC (83649-330-01) 83649-330-03 30 TABLET in 1 BOTTLE, PLASTIC (83649-330-03)

Ingredients (1)

pyrimethamine (25 mg/1)

Linked Drug Pages (1)

Daraprim ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "c7c0666e-57ea-45e4-b3b4-e3950a173011", "openfda": {"nui": ["N0000175934", "N0000000191"], "upc": ["0383649330012", "0383649330036"], "unii": ["Z3614QOX8W"], "rxcui": ["198182", "201912"], "spl_set_id": ["f634f34b-0952-4dd3-9da3-f84b6ab823de"], "pharm_class_epc": ["Dihydrofolate Reductase Inhibitor Antimalarial [EPC]"], "pharm_class_moa": ["Dihydrofolate Reductase Inhibitors [MoA]"], "manufacturer_name": ["TILDE Sciences LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE, PLASTIC (83649-330-01)", "package_ndc": "83649-330-01", "marketing_start_date": "20231212"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (83649-330-03)", "package_ndc": "83649-330-03", "marketing_start_date": "20231212"}], "brand_name": "Daraprim", "product_id": "83649-330_c7c0666e-57ea-45e4-b3b4-e3950a173011", "dosage_form": "TABLET", "pharm_class": ["Dihydrofolate Reductase Inhibitor Antimalarial [EPC]", "Dihydrofolate Reductase Inhibitors [MoA]"], "product_ndc": "83649-330", "generic_name": "pyrimethamine", "labeler_name": "TILDE Sciences LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Daraprim", "active_ingredients": [{"name": "PYRIMETHAMINE", "strength": "25 mg/1"}], "application_number": "NDA008578", "marketing_category": "NDA", "marketing_start_date": "19530123", "listing_expiration_date": "20261231"}