FDA.reportPublic FDA data

LEDERLE LEUCOVORIN

Product NDC
0069-5886
11-digit product format
000695886
Labeler code
0069
Product ID
0069-5886_4734ce39-440d-4a8f-8613-2905408b42cd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
calcium folinate
Dosage form
TABLET
Route
ORAL
Labeler
Pfizer Laboratories Div Pfizer Inc
Marketing category
UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE
Marketing start
2025-12-18
Marketing end
2027-03-31
Substance
LEUCOVORIN CALCIUM
Active strength
5 mg/1
Pharmacologic classes
Folate Analog [EPC], Folic Acid [CS]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
LEDERLE LEUCOVORIN

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
4734ce39-440d-4a8f-8613-2905408b42cdAvailable 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
0069-5886-24LEDERLE LEUCOVORIN24 in 1 BOTTLETABLET241
0069-5886-99LEDERLE LEUCOVORIN100 in 1 BOTTLETABLET1001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0069-5886-24EA - Each0069-5886ceb5b2f6-92de-410e-b9e3-5a5589db813512026-01-08
0069-5886-99EA - Each0069-5886e6550323-7c26-4694-bb70-5a0fefeef11c12026-01-08

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 FOLINATEPfizer Laboratories Div Pfizer Inc4734ce39-440d-4a8f-8613-2905408b42cd2025-12-18Exact identifier
ndc (product): 0069-5886

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197863leucovorin calcium 5 MG Oral TabletPSN4734ce39-440d-4a8f-8613-2905408b42cd1
197863leucovorin 5 MG Oral TabletSCD4734ce39-440d-4a8f-8613-2905408b42cd1
197863leucovorin 5 MG (as leucovorin calcium 5.4 MG) Oral TabletSY4734ce39-440d-4a8f-8613-2905408b42cd1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0069-5886-240006958862424 TABLET in 1 BOTTLE (0069-5886-24) 24 tablet2025-12-182027-03-31NoNoHistorical
0069-5886-9900069588699100 TABLET in 1 BOTTLE (0069-5886-99) 100 tablet2025-12-182027-03-31NoNoHistorical