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

Additional Listing Data#

Finished product
Yes
Brand name base
Leucovorin Calcium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEUCOVORIN CALCIUM500 mg/50mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiRPR1R4C0P4
Rxcui2055036

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