FDA.reportPublic FDA data

Pyrimethamine Leucovorin

Manufacturer
South Coast Specialty Compounding, Inc. d/b/a Park Compounding
Effective date
2015-11-30
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 20:21:35

Label at a glance#

ProductPyrimethamine Leucovorin
Active ingredientPYRIMETHAMINE, LEUCOVORIN CALCIUM
Label structure1 sections

Label contents#

Full prescribing information#

Pyrimethamine Leucovorin (50mg-25mg)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
LEUCOVORIN Pharmacologic Class Indexing3Indexing - Pharmacologic Class20190712
PYRIMETHAMINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
31adef49-84cb-4c51-b122-69e924e10ea3Product name420240827
df40773e-fe5a-474c-8d32-d19c7094e396Product name220240813
927bc290-af6b-41d8-9ce2-cbb0b8d5cf88Product name320240102
cd1aa5b9-18a7-4dc4-8a13-b5c677c859a2Product name120231116
38866763-6a8e-4096-95c3-082a000c243dProduct name120230809
7ce39568-aceb-b33a-23ed-c4964cdcf486Product name220210211
6c712ad1-eecf-448f-84d9-5c0c307a7112Product name120161130

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70260-480-012020-01-31C16284748780-19d75b9d1-032a-f424-e053-dadaa90a57cePyrimethamine Leucovorin (50mg-25mg)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70260-480-01Pyrimethamine Leucovorin100 in 1 BOTTLECAPSULE1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70260-480PYRIMETHAMINE LEUCOVORIN CAPSULE [SOUTH COAST SPECIALTY COMPOUNDING, INC. D/B/A PARK COMPOUNDING]1Legacy NDC, 1 package rows20151201_10fee3d3-6afa-48d4-b65c-02c36048a4a0.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70260-48070260-480-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
PYRIMETHAMINEZ3614QOX8WACTIB
LEUCOVORIN CALCIUMRPR1R4C0P4ACTIM
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
681ce3d4-2635-4586-abdd-14655ba7734d10fee3d3-6afa-48d4-b65c-02c36048a4a02015-11-30Exact identifier
spl id: 681ce3d4-2635-4586-abdd-14655ba7734d
spl set id: 10fee3d3-6afa-48d4-b65c-02c36048a4a0

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.