FDA.reportPublic FDA data

Leucovorin Calcium

Product NDC
0054-4496
11-digit product format
000544496
Labeler code
0054
Product ID
0054-4496_3ea4147c-f529-42ad-8672-4d36ab4c2b37
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Leucovorin Calcium
Dosage form
TABLET
Route
ORAL
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA072733
Marketing category
ANDA
Marketing start
1993-02-22
Substance
LEUCOVORIN CALCIUM
Active strength
5 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 CALCIUM5 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
0054-4496-13Leucovorin Calcium30 in 1 BOTTLETABLET3011
0054-4496-25Leucovorin Calcium100 in 1 BOTTLETABLET10011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0054-4496-13EA - Each0054-44966238f20b-f1e3-4fb1-adc4-df89d5a2fce712012-07-24
0054-4496-25EA - Each0054-449664f182f8-2ba6-4e3d-8bb2-a72b8085278012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LEUCOVORIN CALCIUMACTIVE INGREDIENTRPR1R4C0P4LEUCOVORIN CALCIUM TABLET [ROXANE LABORATORIES, INC.]6
LEUCOVORINACTIVE MOIETYQ573I9DVLPLEUCOVORIN CALCIUM TABLET [ROXANE LABORATORIES, INC.]6
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULEUCOVORIN CALCIUM TABLET [ROXANE LABORATORIES, INC.]6
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48LEUCOVORIN CALCIUM TABLET [ROXANE LABORATORIES, INC.]6
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GLEUCOVORIN CALCIUM TABLET [ROXANE LABORATORIES, INC.]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LEUCOVORIN CALCIUM TABLET [ROXANE LABORATORIES, INC.]6
POVIDONESINACTIVE INGREDIENTFZ989GH94ELEUCOVORIN CALCIUM TABLET [ROXANE LABORATORIES, INC.]6
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LEUCOVORIN CALCIUM TABLET [ROXANE LABORATORIES, INC.]6
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLEUCOVORIN CALCIUM TABLET [ROXANE LABORATORIES, INC.]6
LEUCOVORIN CALCIUMACTIVE INGREDIENTRPR1R4C0P4LEUCOVORIN CALCIUM TABLET [PHYSICIANS TOTAL CARE, INC.]2
LEUCOVORINACTIVE MOIETYQ573I9DVLPLEUCOVORIN CALCIUM TABLET [PHYSICIANS TOTAL CARE, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULEUCOVORIN CALCIUM TABLET [PHYSICIANS TOTAL CARE, INC.]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48LEUCOVORIN CALCIUM TABLET [PHYSICIANS TOTAL CARE, INC.]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GLEUCOVORIN CALCIUM TABLET [PHYSICIANS TOTAL CARE, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LEUCOVORIN CALCIUM TABLET [PHYSICIANS TOTAL CARE, INC.]2
POVIDONEINACTIVE INGREDIENTFZ989GH94ELEUCOVORIN CALCIUM TABLET [PHYSICIANS TOTAL CARE, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LEUCOVORIN CALCIUM TABLET [PHYSICIANS TOTAL CARE, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLEUCOVORIN CALCIUM TABLET [PHYSICIANS TOTAL CARE, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0054-4496LEUCOVORIN CALCIUM TABLET [HIKMA PHARMACEUTICALS USA INC.]10Current NDC, Legacy NDC, 2 package rows20231215_33663425-4731-4977-9127-9e59b6b91497.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197860leucovorin calcium 10 MG Oral TabletPSN33663425-4731-4977-9127-9e59b6b9149711
197861leucovorin calcium 15 MG Oral TabletPSN33663425-4731-4977-9127-9e59b6b9149711
197862leucovorin calcium 25 MG Oral TabletPSN33663425-4731-4977-9127-9e59b6b9149711
197863leucovorin calcium 5 MG Oral TabletPSN33663425-4731-4977-9127-9e59b6b9149711
197860leucovorin 10 MG Oral TabletSCD33663425-4731-4977-9127-9e59b6b9149711
197861leucovorin 15 MG Oral TabletSCD33663425-4731-4977-9127-9e59b6b9149711
197862leucovorin 25 MG Oral TabletSCD33663425-4731-4977-9127-9e59b6b9149711
197863leucovorin 5 MG Oral TabletSCD33663425-4731-4977-9127-9e59b6b9149711
197861folinic acid 15 MG Oral TabletSY33663425-4731-4977-9127-9e59b6b9149711
197860leucovorin 10 MG (as leucovorin calcium 10.8 MG) Oral TabletSY33663425-4731-4977-9127-9e59b6b9149711
197861leucovorin 15 MG (as leucovorin calcium 16.21 MG) Oral TabletSY33663425-4731-4977-9127-9e59b6b9149711
197862leucovorin 25 MG (as leucovorin calcium 27.01 MG) Oral TabletSY33663425-4731-4977-9127-9e59b6b9149711
197863leucovorin 5 MG (as leucovorin calcium 5.4 MG) Oral TabletSY33663425-4731-4977-9127-9e59b6b9149711
197861leucovorin calcium 15 MG Oral TabletPSN084227c1-90eb-4653-807a-eb98cb3cefb82
197863leucovorin calcium 5 MG Oral TabletPSN084227c1-90eb-4653-807a-eb98cb3cefb82
197861leucovorin 15 MG Oral TabletSCD084227c1-90eb-4653-807a-eb98cb3cefb82
197863leucovorin 5 MG Oral TabletSCD084227c1-90eb-4653-807a-eb98cb3cefb82
197861folinic acid 15 MG Oral TabletSY084227c1-90eb-4653-807a-eb98cb3cefb82
197861leucovorin 15 MG (as leucovorin calcium 16.21 MG) Oral TabletSY084227c1-90eb-4653-807a-eb98cb3cefb82
197863leucovorin 5 MG (as leucovorin calcium 5.4 MG) Oral TabletSY084227c1-90eb-4653-807a-eb98cb3cefb82

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0054-4496-130005444961330 TABLET in 1 BOTTLE (0054-4496-13) 30 tablet1993-03-220000-00-00NoNoCurrent
0054-4496-2500054449625100 TABLET in 1 BOTTLE (0054-4496-25) 100 tablet1993-03-220000-00-00NoNoCurrent