FDA.reportPublic FDA data

Leucovorin Calcium

Product NDC
25021-828
11-digit product format
250210828
Labeler code
25021
Product ID
25021-828_4619074b-a86b-41a6-bd98-76d15166764c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
leucovorin calcium
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Sagent Pharmaceuticals
Application
ANDA209110
Marketing category
ANDA
Marketing start
2018-04-15
Substance
LEUCOVORIN CALCIUM
Active strength
500 mg/50mL
Pharmacologic classes
Folate Analog [EPC], Folic Acid [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A209110-001LEUCOVORIN CALCIUM PRESERVATIVE FREELEUCOVORIN CALCIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2017-10-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A209110-001AP

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A209110-001LEUCOVORIN CALCIUM PRESERVATIVE FREEEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2017-10-26a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A209110-001AP1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

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

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Leucovorin CalciumLEUCOVORIN CALCIUMSagent Pharmaceuticalsc0cbcbf6-6fd2-4cf3-877a-bb0fe3df4e592026-06-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209110
application number: ANDA209110
ndc (product): 25021-828

Additional Listing Data#

Finished product
Yes
Brand name base
Leucovorin Calcium
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEUCOVORIN CALCIUM500 mg/50mL

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
2055036Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c0cbcbf6-6fd2-4cf3-877a-bb0fe3df4e59Available 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
25021-828-50Leucovorin Calcium1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,14
25021-828-50Leucovorin Calcium50 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,504

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
25021-828-50EA - Each25021-8280e1a1071-0e86-4ba0-954b-f1ca54a49b8c12018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25021-828LEUCOVORIN CALCIUM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SAGENT PHARMACEUTICALS]4Current NDC, Legacy NDC, 2 package rows20201204_c0cbcbf6-6fd2-4cf3-877a-bb0fe3df4e59.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2055036leucovorin 500 MG InjectionPSNc0cbcbf6-6fd2-4cf3-877a-bb0fe3df4e594
2055036leucovorin 500 MG InjectionSCDc0cbcbf6-6fd2-4cf3-877a-bb0fe3df4e594
2055036leucovorin (as leucovorin calcium) 500 MG InjectionSYc0cbcbf6-6fd2-4cf3-877a-bb0fe3df4e594

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
25021-828-50250210828501 VIAL in 1 CARTON (25021-828-50) / 50 mL in 1 VIAL1 vial2018-04-150000-00-00NoNoCurrent