FDA.reportPublic FDA data

LEUCOVORIN CALCIUM

Product NDC
69315-186
11-digit product format
693150186
Labeler code
69315
Product ID
69315-186_f6c54ab5-7d54-4530-955d-206903b9dcad
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LEUCOVORIN CALCIUM
Dosage form
TABLET
Route
ORAL
Labeler
Leading Pharma, LLC
Application
ANDA213929
Marketing category
ANDA
Marketing start
2020-11-16
Substance
LEUCOVORIN CALCIUM
Active strength
15 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 CALCIUM15 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69315-186-242023-09-11C16284748780-1f386c649-e01c-0266-e053-dadaa90a7c1aLeucovorin Calcium Tablets USP 5 mg, 10 mg, 15 mg and 25 mg Rx only
69315-186-242023-01-30C16284748780-1f386c649-e01c-0266-e053-dadaa90a7c1aLeucovorin Calcium Tablets USP 5 mg, 10 mg, 15 mg and 25 mg Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69315-186-24LEUCOVORIN CALCIUM24 in 1 BOTTLETABLET247

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69315-186-24EA - Each69315-1863ca6d396-88d7-4f56-a13e-f0b53c22752e12021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69315-186LEUCOVORIN CALCIUM TABLET [LEADING PHARMA, LLC]7Current NDC, Legacy NDC, 1 package rows20230912_c8102043-79f2-421a-b849-94bac19007a6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197860leucovorin calcium 10 MG Oral TabletPSNc8102043-79f2-421a-b849-94bac19007a67
197861leucovorin calcium 15 MG Oral TabletPSNc8102043-79f2-421a-b849-94bac19007a67
197862leucovorin calcium 25 MG Oral TabletPSNc8102043-79f2-421a-b849-94bac19007a67
197863leucovorin calcium 5 MG Oral TabletPSNc8102043-79f2-421a-b849-94bac19007a67
197860leucovorin 10 MG Oral TabletSCDc8102043-79f2-421a-b849-94bac19007a67
197861leucovorin 15 MG Oral TabletSCDc8102043-79f2-421a-b849-94bac19007a67
197862leucovorin 25 MG Oral TabletSCDc8102043-79f2-421a-b849-94bac19007a67
197863leucovorin 5 MG Oral TabletSCDc8102043-79f2-421a-b849-94bac19007a67
197861folinic acid 15 MG Oral TabletSYc8102043-79f2-421a-b849-94bac19007a67
197860leucovorin 10 MG (as leucovorin calcium 10.8 MG) Oral TabletSYc8102043-79f2-421a-b849-94bac19007a67
197861leucovorin 15 MG (as leucovorin calcium 16.21 MG) Oral TabletSYc8102043-79f2-421a-b849-94bac19007a67
197862leucovorin 25 MG (as leucovorin calcium 27.01 MG) Oral TabletSYc8102043-79f2-421a-b849-94bac19007a67
197863leucovorin 5 MG (as leucovorin calcium 5.4 MG) Oral TabletSYc8102043-79f2-421a-b849-94bac19007a67

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69315-186-246931501862424 TABLET in 1 BOTTLE (69315-186-24) 24 tablet2020-11-160000-00-00NoNoCurrent