Daraprim
DARAPRIM (pyrimethamine)
Approved
Approval ID
f634f34b-0952-4dd3-9da3-f84b6ab823de
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 7, 2023
Manufacturers
FDA
TILDE Sciences LLC
DUNS: 119033490
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
pyrimethamine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code83649-330
Application NumberNDA008578
Product Classification
M
Marketing Category
C73594
G
Generic Name
pyrimethamine
Product Specifications
Route of AdministrationORAL
Effective DateDecember 7, 2023
FDA Product Classification
INGREDIENTS (5)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
PYRIMETHAMINEActive
Quantity: 25 mg in 1 1
Code: Z3614QOX8W
Classification: ACTIB
STARCH, POTATOInactive
Code: 8I089SAH3T
Classification: IACT
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
Drug Labeling Information
DESCRIPTION SECTION
LOINC: 34089-3Updated: 12/7/2023
DESCRIPTION
DARAPRIM (pyrimethamine) is an antiparasitic compound available in tablet form for oral administration. Each scored tablet contains 25 mg pyrimethamine and the inactive ingredients corn and potato starch, lactose, and magnesium stearate.
Pyrimethamine, known chemically as 5-(4- chlorophenyl)-6-ethyl-2, 4-pyrimidinediamine, has the following structural formula:
