FDA.reportPublic FDA data

LEDERLE LEUCOVORIN

Product NDC
73591-5886
11-digit product format
735915886
Labeler code
73591
Product ID
73591-5886_4457d4e3-5943-1a73-e063-6394a90abb24
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CALCIUM FOLINATE
Dosage form
TABLET
Route
ORAL
Labeler
FARMASIERRA MANUFACTURING SL
Marketing category
UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE
Marketing start
2025-11-26
Substance
LEUCOVORIN CALCIUM
Active strength
5 mg/1
Pharmacologic classes
Folate Analog [EPC], Folic Acid [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
LEDERLE LEUCOVORIN
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEUCOVORIN CALCIUM5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
RPR1R4C0P4Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197863Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4457d4e3-5942-1a73-e063-6394a90abb24Available on FDA.report

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73591-5886-1LEDERLE LEUCOVORIN100 in 1 BOTTLE, PLASTICTABLET1001
73591-5886-2LEDERLE LEUCOVORIN24 in 1 BOTTLE, PLASTICTABLET241

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
LEDERLE LEUCOVORINCALCIUM FOLINATEFARMASIERRA MANUFACTURING SL4457d4e3-5942-1a73-e063-6394a90abb242025-11-24Exact identifier
ndc (product): 73591-5886

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197863leucovorin calcium 5 MG Oral TabletPSN4457d4e3-5942-1a73-e063-6394a90abb241
197863leucovorin 5 MG Oral TabletSCD4457d4e3-5942-1a73-e063-6394a90abb241
197863leucovorin 5 MG (as leucovorin calcium 5.4 MG) Oral TabletSY4457d4e3-5942-1a73-e063-6394a90abb241

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
73591-5886-173591588601100 TABLET in 1 BOTTLE, PLASTIC (73591-5886-1) 100 tablet2025-11-26NoNoCurrent
73591-5886-27359158860224 TABLET in 1 BOTTLE, PLASTIC (73591-5886-2) 24 tablet2025-11-26NoNoCurrent