FDA.reportPublic FDA data

Leucovorin Calcium

Product NDC
68001-417
11-digit product format
680010417
Labeler code
68001
Product ID
68001-417_d5ee26ca-d963-687f-e053-2a95a90a2a50
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Leucovorin Calcium
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
BluePoint Laboratories
Application
ANDA040056
Marketing category
ANDA
Marketing start
2019-09-26
Substance
LEUCOVORIN CALCIUM
Active strength
200 mg/20mL
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 CALCIUM200 mg/20mL

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
68001-417-37Leucovorin Calcium1 in 1 BOX, UNIT-DOSEINJECTION, POWDER, LYOPHILIZED,13
68001-417-37Leucovorin Calcium20 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,203

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68001-417-37EA - Each68001-41723c17af8-7243-4536-981a-720b15d111c712019-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68001-417LEUCOVORIN CALCIUM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [BLUEPOINT LABORATORIES]3Current NDC, Legacy NDC, 2 package rows20220125_e9b47126-8b52-43ff-85c4-33d32b3d8326.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1803932leucovorin 100 MG InjectionPSNe9b47126-8b52-43ff-85c4-33d32b3d83263
1803937leucovorin 200 MG InjectionPSNe9b47126-8b52-43ff-85c4-33d32b3d83263
237788leucovorin 350 MG InjectionPSNe9b47126-8b52-43ff-85c4-33d32b3d83263
1803932leucovorin 100 MG InjectionSCDe9b47126-8b52-43ff-85c4-33d32b3d83263
1803937leucovorin 200 MG InjectionSCDe9b47126-8b52-43ff-85c4-33d32b3d83263
237788leucovorin 350 MG InjectionSCDe9b47126-8b52-43ff-85c4-33d32b3d83263
1803932leucovorin (as leucovorin calcium) 100 MG InjectionSYe9b47126-8b52-43ff-85c4-33d32b3d83263
1803937leucovorin (as leucovorin calcium) 200 MG InjectionSYe9b47126-8b52-43ff-85c4-33d32b3d83263
237788leucovorin (as leucovorin calcium) 350 MG InjectionSYe9b47126-8b52-43ff-85c4-33d32b3d83263
237788leucovorin 350 MG per 17.5 ML Lyophilized Powder for InjectionSYe9b47126-8b52-43ff-85c4-33d32b3d83263

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68001-417-37680010417371 VIAL in 1 BOX, UNIT-DOSE (68001-417-37) / 20 mL in 1 VIAL1 vial2019-09-260000-00-00NoNoCurrent