Leucovorin Calcium

Product NDC
0904-7584
11-digit product format
009047584
Labeler code
0904
Product ID
0904-7584_273407f5-0be2-435a-b7a8-f21be8ffbb3c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Leucovorin Calcium
Dosage form
TABLET
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA211132
Marketing category
ANDA
Marketing start
2026-03-27
Substance
LEUCOVORIN CALCIUM
Active strength
25 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 CALCIUM25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiRPR1R4C0P4
Rxcui197862

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
0904-7584-10Leucovorin Calcium20 in 1 CARTONTABLET201
0904-7584-10Leucovorin Calcium1 in 1 BLISTER PACKTABLET11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197862leucovorin calcium 25 MG Oral TabletPSN273407f5-0be2-435a-b7a8-f21be8ffbb3c1
197862leucovorin 25 MG Oral TabletSCD273407f5-0be2-435a-b7a8-f21be8ffbb3c1
197862leucovorin 25 MG (as leucovorin calcium 27.01 MG) Oral TabletSY273407f5-0be2-435a-b7a8-f21be8ffbb3c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0904-7584-100090475841020 BLISTER PACK in 1 CARTON (0904-7584-10) / 1 TABLET in 1 BLISTER PACK20 blister pack2026-03-27NoNoHistorical