FDA.reportPublic FDA data

leucovorin calcium

Product NDC
68001-648
11-digit product format
680010648
Labeler code
68001
Product ID
68001-648_3ff11eb8-de81-1e0d-e063-6394a90a0f7c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
leucovorin calcium
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
BluePoint Laboratories
Application
ANDA216590
Marketing category
ANDA
Marketing start
2025-05-10
Substance
LEUCOVORIN CALCIUM
Active strength
100 mg/10mL
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 CALCIUM100 mg/10mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiRPR1R4C0P4
Rxcui237788, 1803932, 1803937

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
68001-648-36leucovorin calcium1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,12
68001-648-36leucovorin calcium10 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68001-648-36EA - Each68001-6485e6f0c67-1791-43fa-9dfb-2bfb577c957112025-07-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68001-648LEUCOVORIN CALCIUM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [BLUEPOINT LABORATORIES]1Current NDC, 2 package rows20250511_f579879c-7d53-4663-8ad8-84b8b645cda5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1803932leucovorin 100 MG InjectionPSNf579879c-7d53-4663-8ad8-84b8b645cda52
1803937leucovorin 200 MG InjectionPSNf579879c-7d53-4663-8ad8-84b8b645cda52
237788leucovorin 350 MG InjectionPSNf579879c-7d53-4663-8ad8-84b8b645cda52
1803932leucovorin 100 MG InjectionSCDf579879c-7d53-4663-8ad8-84b8b645cda52
1803937leucovorin 200 MG InjectionSCDf579879c-7d53-4663-8ad8-84b8b645cda52
237788leucovorin 350 MG InjectionSCDf579879c-7d53-4663-8ad8-84b8b645cda52
1803932leucovorin (as leucovorin calcium) 100 MG InjectionSYf579879c-7d53-4663-8ad8-84b8b645cda52
1803937leucovorin (as leucovorin calcium) 200 MG InjectionSYf579879c-7d53-4663-8ad8-84b8b645cda52
237788leucovorin (as leucovorin calcium) 350 MG InjectionSYf579879c-7d53-4663-8ad8-84b8b645cda52
237788leucovorin 350 MG per 17.5 ML Lyophilized Powder for InjectionSYf579879c-7d53-4663-8ad8-84b8b645cda52

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68001-648-36680010648361 VIAL, SINGLE-DOSE in 1 CARTON (68001-648-36) / 10 mL in 1 VIAL, SINGLE-DOSE2025-08-14NoNoCurrent