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Levoleucovorin

These highlights do not include all the information needed to use LEVOLEUCOVORIN INJECTION safely and effectively. See full prescribing information for LEVOLEUCOVORIN INJECTION.LEVOLEUCOVORIN injection, for intravenous useInitial U.S. Approval: 1952 (-leucovorin)

Approved
Approval ID

059a3306-6207-497f-a947-33198f18761f

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Aug 1, 2023

Manufacturers
FDA

Meitheal Pharmaceuticals Inc.

DUNS: 080548348

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

levoleucovorin calcium

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code71288-105
Application NumberANDA211002
Product Classification
M
Marketing Category
C73584
G
Generic Name
levoleucovorin calcium
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 31, 2020
FDA Product Classification

INGREDIENTS (4)

sodium chlorideInactive
Quantity: 8.3 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
levoleucovorin calciumActive
Quantity: 10 mg in 1 mL
Code: 778XL6VBS8
Classification: ACTIM
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT

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Levoleucovorin - FDA Drug Approval Details