FDA.reportPublic FDA data

Leucovorin Calcium

Product NDC
0555-0485
11-digit product format
005550485
Labeler code
0555
Product ID
0555-0485_3ba61b64-dd4e-44d7-8348-85a193c7c267
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Leucovorin Calcium
Dosage form
TABLET
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA071199
Marketing category
ANDA
Marketing start
1990-06-30
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, 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
0555-0485-27Leucovorin Calcium25 in 1 BOTTLETABLET2518

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0555-0485-27EA - Each0555-04851d78c335-47d7-4535-a925-39d46e0cee4d12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LEUCOVORIN CALCIUMACTIVE INGREDIENTRPR1R4C0P4LEUCOVORIN CALCIUM TABLET [BARR LABORATORIES INC.]5
LEUCOVORINACTIVE MOIETYQ573I9DVLPLEUCOVORIN CALCIUM TABLET [BARR LABORATORIES INC.]5
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933LEUCOVORIN CALCIUM TABLET [BARR LABORATORIES INC.]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULEUCOVORIN CALCIUM TABLET [BARR LABORATORIES INC.]5
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48LEUCOVORIN CALCIUM TABLET [BARR LABORATORIES INC.]5
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GLEUCOVORIN CALCIUM TABLET [BARR LABORATORIES INC.]5
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDLEUCOVORIN CALCIUM TABLET [BARR LABORATORIES INC.]5
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLEUCOVORIN CALCIUM TABLET [BARR LABORATORIES INC.]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LEUCOVORIN CALCIUM TABLET [BARR LABORATORIES INC.]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LEUCOVORIN CALCIUM TABLET [BARR LABORATORIES INC.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0555-0485LEUCOVORIN CALCIUM TABLET [TEVA PHARMACEUTICALS USA, INC.]15Current NDC, Legacy NDC, 1 package rows20241204_94669fc8-3c1c-4228-be27-09a1cd468c36.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197862leucovorin calcium 25 MG Oral TabletPSN94669fc8-3c1c-4228-be27-09a1cd468c3618
197863leucovorin calcium 5 MG Oral TabletPSN94669fc8-3c1c-4228-be27-09a1cd468c3618
197862leucovorin 25 MG Oral TabletSCD94669fc8-3c1c-4228-be27-09a1cd468c3618
197863leucovorin 5 MG Oral TabletSCD94669fc8-3c1c-4228-be27-09a1cd468c3618
197862leucovorin 25 MG (as leucovorin calcium 27.01 MG) Oral TabletSY94669fc8-3c1c-4228-be27-09a1cd468c3618
197863leucovorin 5 MG (as leucovorin calcium 5.4 MG) Oral TabletSY94669fc8-3c1c-4228-be27-09a1cd468c3618
197862leucovorin calcium 25 MG Oral TabletPSNf7004cbd-9827-466e-9683-adce4f13c6a68
197862leucovorin 25 MG Oral TabletSCDf7004cbd-9827-466e-9683-adce4f13c6a68
197862leucovorin 25 MG (as leucovorin calcium 27.01 MG) Oral TabletSYf7004cbd-9827-466e-9683-adce4f13c6a68

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0555-0485-0400555048504500 TABLET in 1 BOTTLE (0555-0485-04) 500 tablet1990-06-300000-00-00NoNoCurrent
0555-0485-270055504852725 TABLET in 1 BOTTLE (0555-0485-27) 25 tablet1990-06-300000-00-00NoNoCurrent