Leucovorin Calcium

Product NDC
70436-120
11-digit product format
704360120
Labeler code
70436
Product ID
70436-120_2a4aaed3-885e-bc10-e063-6294a90a61af
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
leucovorin calcium
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Slate Run Pharmaceuticals, LLC
Application
ANDA217021
Marketing category
ANDA
Marketing start
2023-07-10
Substance
LEUCOVORIN CALCIUM
Active strength
500 mg/1
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/1

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
70436-120-80Leucovorin Calcium500 in 1 VIALINJECTION, POWDER, LYOPHILIZED,5002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70436-120-80EA - Each70436-12003c9bcef-202d-4abe-83c8-b8c270a94d7312024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70436-120LEUCOVORIN CALCIUM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SLATE RUN PHARMACEUTICALS, LLC]2Current NDC, 1 package rows20241229_d8bdd60c-9a1c-4ef4-ba6b-b911849128f1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1803932leucovorin 100 MG InjectionPSNd8bdd60c-9a1c-4ef4-ba6b-b911849128f12
1803937leucovorin 200 MG InjectionPSNd8bdd60c-9a1c-4ef4-ba6b-b911849128f12
237788leucovorin 350 MG InjectionPSNd8bdd60c-9a1c-4ef4-ba6b-b911849128f12
1803930leucovorin 50 MG InjectionPSNd8bdd60c-9a1c-4ef4-ba6b-b911849128f12
2055036leucovorin 500 MG InjectionPSNd8bdd60c-9a1c-4ef4-ba6b-b911849128f12
1803932leucovorin 100 MG InjectionSCDd8bdd60c-9a1c-4ef4-ba6b-b911849128f12
1803937leucovorin 200 MG InjectionSCDd8bdd60c-9a1c-4ef4-ba6b-b911849128f12
237788leucovorin 350 MG InjectionSCDd8bdd60c-9a1c-4ef4-ba6b-b911849128f12
1803930leucovorin 50 MG InjectionSCDd8bdd60c-9a1c-4ef4-ba6b-b911849128f12
2055036leucovorin 500 MG InjectionSCDd8bdd60c-9a1c-4ef4-ba6b-b911849128f12
1803932leucovorin (as leucovorin calcium) 100 MG InjectionSYd8bdd60c-9a1c-4ef4-ba6b-b911849128f12
1803937leucovorin (as leucovorin calcium) 200 MG InjectionSYd8bdd60c-9a1c-4ef4-ba6b-b911849128f12
237788leucovorin (as leucovorin calcium) 350 MG InjectionSYd8bdd60c-9a1c-4ef4-ba6b-b911849128f12
1803930leucovorin (as leucovorin calcium) 50 MG InjectionSYd8bdd60c-9a1c-4ef4-ba6b-b911849128f12
2055036leucovorin (as leucovorin calcium) 500 MG InjectionSYd8bdd60c-9a1c-4ef4-ba6b-b911849128f12
237788leucovorin 350 MG per 17.5 ML Lyophilized Powder for InjectionSYd8bdd60c-9a1c-4ef4-ba6b-b911849128f12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70436-120-8070436012080500 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (70436-120-80) 2023-07-10NoNoCurrent