Pyrimethamine Leucovorin
Pyrimethamine Leucovorin (12.5mg-2.5mg)
Approved
Approval ID
6f79fc4a-41fc-4368-9312-8baebd985df0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 27, 2015
Manufacturers
FDA
ImprimisRx PA, Inc. d/b/a ImprimisRx
DUNS: 080044737
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Pyrimethamine Leucovorin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70271-430
Product Classification
G
Generic Name
Pyrimethamine Leucovorin
Product Specifications
Route of AdministrationORAL
Effective DateNovember 27, 2015
FDA Product Classification
INGREDIENTS (3)
PYRIMETHAMINEActive
Quantity: 12.5 mg in 1 1
Code: Z3614QOX8W
Classification: ACTIB
LEUCOVORIN CALCIUMActive
Quantity: 2.5 mg in 1 1
Code: RPR1R4C0P4
Classification: ACTIM
CELLULOSE, MICROCRYSTALLINEInactive
Quantity: 100 mg in 1 1
Code: OP1R32D61U
Classification: IACT
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
LOINC: 51945-4Updated: 11/27/2015
Pyrimethamine Leucovorin (12.5mg-2.5mg)
SPL UNCLASSIFIED SECTION
LOINC: 42229-5Updated: 11/27/2015