FDA.reportPublic FDA data

leucovorin calcium

Product NDC
71288-161
11-digit product format
712880161
Labeler code
71288
Product ID
71288-161_077a459b-e884-4452-aed3-0857a38ce26f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
leucovorin calcium
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Meitheal Pharmaceuticals Inc.
Application
ANDA216590
Marketing category
ANDA
Marketing start
2023-07-19
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, 1803930, 1803932, 1803937, 2055036

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
71288-161-20leucovorin calcium10 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,107
71288-161-20leucovorin calcium1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71288-161-20EA - Each71288-161e1123c06-0cdf-40f5-9bd1-99eafd718e1812023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71288-161LEUCOVORIN CALCIUM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MEITHEAL PHARMACEUTICALS INC.]7Current NDC, 2 package rows20250322_9df20901-6980-4d4e-89ec-40f3c1f91852.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1803932leucovorin 100 MG InjectionPSN9df20901-6980-4d4e-89ec-40f3c1f918527
1803937leucovorin 200 MG InjectionPSN9df20901-6980-4d4e-89ec-40f3c1f918527
237788leucovorin 350 MG InjectionPSN9df20901-6980-4d4e-89ec-40f3c1f918527
1803930leucovorin 50 MG InjectionPSN9df20901-6980-4d4e-89ec-40f3c1f918527
2055036leucovorin 500 MG InjectionPSN9df20901-6980-4d4e-89ec-40f3c1f918527
1803932leucovorin 100 MG InjectionSCD9df20901-6980-4d4e-89ec-40f3c1f918527
1803937leucovorin 200 MG InjectionSCD9df20901-6980-4d4e-89ec-40f3c1f918527
237788leucovorin 350 MG InjectionSCD9df20901-6980-4d4e-89ec-40f3c1f918527
1803930leucovorin 50 MG InjectionSCD9df20901-6980-4d4e-89ec-40f3c1f918527
2055036leucovorin 500 MG InjectionSCD9df20901-6980-4d4e-89ec-40f3c1f918527
1803932leucovorin (as leucovorin calcium) 100 MG InjectionSY9df20901-6980-4d4e-89ec-40f3c1f918527
1803937leucovorin (as leucovorin calcium) 200 MG InjectionSY9df20901-6980-4d4e-89ec-40f3c1f918527
237788leucovorin (as leucovorin calcium) 350 MG InjectionSY9df20901-6980-4d4e-89ec-40f3c1f918527
1803930leucovorin (as leucovorin calcium) 50 MG InjectionSY9df20901-6980-4d4e-89ec-40f3c1f918527
2055036leucovorin (as leucovorin calcium) 500 MG InjectionSY9df20901-6980-4d4e-89ec-40f3c1f918527
237788leucovorin 350 MG per 17.5 ML Lyophilized Powder for InjectionSY9df20901-6980-4d4e-89ec-40f3c1f918527

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71288-161-20712880161201 VIAL, SINGLE-DOSE in 1 CARTON (71288-161-20) / 10 mL in 1 VIAL, SINGLE-DOSE2023-07-19NoNoHistorical