MedPath

Pyrimethamine

PRESCRIBING INFORMATION

Approved
Approval ID

b82d019d-c235-4b38-a097-6fe3e6fc8461

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Mar 20, 2023

Manufacturers
FDA

DR.REDDYS LABORATORIES INC

DUNS: 802315887

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 Code43598-672
Application NumberANDA207127
Product Classification
M
Marketing Category
C73584
G
Generic Name
pyrimethamine
Product Specifications
Route of AdministrationORAL
Effective DateMarch 20, 2023
FDA Product Classification

INGREDIENTS (4)

STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
PYRIMETHAMINEActive
Quantity: 25 mg in 1 1
Code: Z3614QOX8W
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

Pyrimethamine - FDA Drug Approval Details