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FDA Approval

Daraprim

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
TILDE Sciences LLC
DUNS: 119033490
Effective Date
December 7, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Pyrimethamine(25 mg in 1 1)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Nutra-Med Packaging LLC

TILDE Sciences LLC

022004902

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Daraprim

Product Details

NDC Product Code
83649-330
Application Number
NDA008578
Marketing Category
NDA (C73594)
Route of Administration
ORAL
Effective Date
December 7, 2023
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
Code: Z3614QOX8WClass: ACTIBQuantity: 25 mg in 1 1
STARCH, POTATOInactive
Code: 8I089SAH3TClass: IACT
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98GClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT

Drug Labeling Information

Complete FDA-approved labeling information including indications, dosage, warnings, contraindications, and other essential prescribing details.

DESCRIPTION SECTION

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:

Chemical Structure


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