FDA.reportPublic FDA data

Leucovorin Calcium

Product NDC
50742-182
11-digit product format
507420182
Labeler code
50742
Product ID
50742-182_93e939b7-2201-442a-a2be-7c5804f8be6f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Leucovorin Calcium
Dosage form
TABLET
Route
ORAL
Labeler
Ingenus Pharmaceuticals, LLC
Application
ANDA211132
Marketing category
ANDA
Marketing start
2020-07-30
Substance
LEUCOVORIN CALCIUM
Active strength
10 mg/1
Pharmacologic classes
Folate Analog [EPC], Folic Acid [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Leucovorin Calcium
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEUCOVORIN CALCIUM10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiRPR1R4C0P4
Rxcui197860, 197861, 197862, 197863

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
50742-182-12Leucovorin Calcium12 in 1 BOTTLETABLET125
50742-182-24Leucovorin Calcium24 in 1 BOTTLETABLET245

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50742-182LEUCOVORIN CALCIUM TABLET [INGENUS PHARMACEUTICALS, LLC]4Current NDC, Legacy NDC, 2 package rows20241116_7409cdee-9093-47af-a4c4-2c55ce1b6361.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197860leucovorin calcium 10 MG Oral TabletPSN7409cdee-9093-47af-a4c4-2c55ce1b63615
197861leucovorin calcium 15 MG Oral TabletPSN7409cdee-9093-47af-a4c4-2c55ce1b63615
197862leucovorin calcium 25 MG Oral TabletPSN7409cdee-9093-47af-a4c4-2c55ce1b63615
197863leucovorin calcium 5 MG Oral TabletPSN7409cdee-9093-47af-a4c4-2c55ce1b63615
197860leucovorin 10 MG Oral TabletSCD7409cdee-9093-47af-a4c4-2c55ce1b63615
197861leucovorin 15 MG Oral TabletSCD7409cdee-9093-47af-a4c4-2c55ce1b63615
197862leucovorin 25 MG Oral TabletSCD7409cdee-9093-47af-a4c4-2c55ce1b63615
197863leucovorin 5 MG Oral TabletSCD7409cdee-9093-47af-a4c4-2c55ce1b63615
197861folinic acid 15 MG Oral TabletSY7409cdee-9093-47af-a4c4-2c55ce1b63615
197860leucovorin 10 MG (as leucovorin calcium 10.8 MG) Oral TabletSY7409cdee-9093-47af-a4c4-2c55ce1b63615
197861leucovorin 15 MG (as leucovorin calcium 16.21 MG) Oral TabletSY7409cdee-9093-47af-a4c4-2c55ce1b63615
197862leucovorin 25 MG (as leucovorin calcium 27.01 MG) Oral TabletSY7409cdee-9093-47af-a4c4-2c55ce1b63615
197863leucovorin 5 MG (as leucovorin calcium 5.4 MG) Oral TabletSY7409cdee-9093-47af-a4c4-2c55ce1b63615

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50742-182-125074201821212 TABLET in 1 BOTTLE (50742-182-12) 12 tablet2020-07-300000-00-00NoNoCurrent
50742-182-245074201822424 TABLET in 1 BOTTLE (50742-182-24) 24 tablet2020-07-300000-00-00NoNoCurrent