FDA.reportPublic FDA data

Leucovorin Calcium

Product NDC
42806-133
11-digit product format
428060133
Labeler code
42806
Product ID
42806-133_9db189e6-7ecc-465c-8197-c454350a45dc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Leucovorin Calcium
Dosage form
TABLET
Route
ORAL
Labeler
Epic Pharma LLC
Application
ANDA074544
Marketing category
ANDA
Marketing start
2021-01-01
Substance
LEUCOVORIN CALCIUM
Active strength
10 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 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
42806-133-21Leucovorin Calcium12 in 1 BOTTLETABLET127
42806-133-24Leucovorin Calcium24 in 1 BOTTLETABLET247

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42806-133-21EA - Each42806-133dd9598ab-be52-4f83-bc8c-49323a26797712021-10-08
42806-133-24EA - Each42806-133a70a43df-952a-4f5a-8ec4-af2eeb59985512021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42806-133LEUCOVORIN CALCIUM TABLET [EPIC PHARMA LLC]7Current NDC, Legacy NDC, 2 package rows20231221_2627a485-05b5-4dab-ac20-dc840e5c469d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197860leucovorin calcium 10 MG Oral TabletPSN2627a485-05b5-4dab-ac20-dc840e5c469d7
197861leucovorin calcium 15 MG Oral TabletPSN2627a485-05b5-4dab-ac20-dc840e5c469d7
197862leucovorin calcium 25 MG Oral TabletPSN2627a485-05b5-4dab-ac20-dc840e5c469d7
197863leucovorin calcium 5 MG Oral TabletPSN2627a485-05b5-4dab-ac20-dc840e5c469d7
197860leucovorin 10 MG Oral TabletSCD2627a485-05b5-4dab-ac20-dc840e5c469d7
197861leucovorin 15 MG Oral TabletSCD2627a485-05b5-4dab-ac20-dc840e5c469d7
197862leucovorin 25 MG Oral TabletSCD2627a485-05b5-4dab-ac20-dc840e5c469d7
197863leucovorin 5 MG Oral TabletSCD2627a485-05b5-4dab-ac20-dc840e5c469d7
197861folinic acid 15 MG Oral TabletSY2627a485-05b5-4dab-ac20-dc840e5c469d7
197860leucovorin 10 MG (as leucovorin calcium 10.8 MG) Oral TabletSY2627a485-05b5-4dab-ac20-dc840e5c469d7
197861leucovorin 15 MG (as leucovorin calcium 16.21 MG) Oral TabletSY2627a485-05b5-4dab-ac20-dc840e5c469d7
197862leucovorin 25 MG (as leucovorin calcium 27.01 MG) Oral TabletSY2627a485-05b5-4dab-ac20-dc840e5c469d7
197863leucovorin 5 MG (as leucovorin calcium 5.4 MG) Oral TabletSY2627a485-05b5-4dab-ac20-dc840e5c469d7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42806-133-214280601332112 TABLET in 1 BOTTLE (42806-133-21) 12 tablet2021-01-010000-00-00NoNoCurrent
42806-133-244280601332424 TABLET in 1 BOTTLE (42806-133-24) 24 tablet2021-01-010000-00-00NoNoCurrent