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Pyrimethamine Leucovorin

Pyrimethamine Leucovorin (12.5mg-2.5mg)

Approved
Approval ID

d3881dcd-5b75-4b8d-b417-3ce669e26248

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Nov 25, 2015

Manufacturers
FDA

South Coast Specialty Compounding, Inc. d/b/a Park Compounding

DUNS: 069419104

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 Code70260-430
Product Classification
G
Generic Name
Pyrimethamine Leucovorin
Product Specifications
Route of AdministrationORAL
Effective DateNovember 25, 2015
FDA Product Classification

INGREDIENTS (3)

PYRIMETHAMINEActive
Quantity: 12.5 mg in 1 1
Code: Z3614QOX8W
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Quantity: 100 mg in 1 1
Code: OP1R32D61U
Classification: IACT
LEUCOVORIN CALCIUMActive
Quantity: 2.5 mg in 1 1
Code: RPR1R4C0P4
Classification: ACTIM

Drug Labeling Information

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 11/25/2015

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Pyrimethamine Leucovorin - FDA Drug Approval Details