FDA.reportPublic FDA data

Leucovorin Calcium

Product NDC
0143-9553
11-digit product format
001439553
Labeler code
0143
Product ID
0143-9553_e2d1484b-2920-45ab-9207-4caa5285fef4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Leucovorin Calcium
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA040056
Marketing category
ANDA
Marketing start
1995-05-23
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, 1803930, 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
0143-9553-01Leucovorin Calcium20 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,207
0143-9553-01Leucovorin Calcium1 in 1 BOX, UNIT-DOSEINJECTION, POWDER, LYOPHILIZED,17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9553-01EA - Each0143-9553f8d6913a-36be-4e09-909a-473424e4617212017-07-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9553LEUCOVORIN CALCIUM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HIKMA PHARMACEUTICALS USA INC.]7Current NDC, Legacy NDC, 2 package rows20220121_cc52077f-5663-4f79-a273-0aecf655e038.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1803932leucovorin 100 MG InjectionPSNcc52077f-5663-4f79-a273-0aecf655e0387
1803937leucovorin 200 MG InjectionPSNcc52077f-5663-4f79-a273-0aecf655e0387
237788leucovorin 350 MG InjectionPSNcc52077f-5663-4f79-a273-0aecf655e0387
1803930leucovorin 50 MG InjectionPSNcc52077f-5663-4f79-a273-0aecf655e0387
1803932leucovorin 100 MG InjectionSCDcc52077f-5663-4f79-a273-0aecf655e0387
1803937leucovorin 200 MG InjectionSCDcc52077f-5663-4f79-a273-0aecf655e0387
237788leucovorin 350 MG InjectionSCDcc52077f-5663-4f79-a273-0aecf655e0387
1803930leucovorin 50 MG InjectionSCDcc52077f-5663-4f79-a273-0aecf655e0387
1803932leucovorin (as leucovorin calcium) 100 MG InjectionSYcc52077f-5663-4f79-a273-0aecf655e0387
1803937leucovorin (as leucovorin calcium) 200 MG InjectionSYcc52077f-5663-4f79-a273-0aecf655e0387
237788leucovorin (as leucovorin calcium) 350 MG InjectionSYcc52077f-5663-4f79-a273-0aecf655e0387
1803930leucovorin (as leucovorin calcium) 50 MG InjectionSYcc52077f-5663-4f79-a273-0aecf655e0387
237788leucovorin 350 MG per 17.5 ML Lyophilized Powder for InjectionSYcc52077f-5663-4f79-a273-0aecf655e0387

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0143-9553-01001439553011 VIAL in 1 BOX, UNIT-DOSE (0143-9553-01) / 20 mL in 1 VIAL1 vial1995-05-230000-00-00NoNoCurrent