LEVOLEUCOVORIN CALCIUM
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 use Initial U.S. Approval: 1952 ( -leucovorin)
Approved
Approval ID
c10b0c18-dd7c-4a76-a79b-b8d38a08ab87
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 31, 2023
Manufacturers
FDA
Hainan Poly Pharm. Co., Ltd.
DUNS: 654561638
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
levoleucovorin injection
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code14335-341
Application NumberANDA217314
Product Classification
M
Marketing Category
C73584
G
Generic Name
levoleucovorin injection
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMay 31, 2023
FDA Product Classification
INGREDIENTS (4)
WATERInactive
Quantity: 1 mL in 1 1
Code: 059QF0KO0R
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 8.3 mg in 1 1
Code: 451W47IQ8X
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
LEVOLEUCOVORIN CALCIUMActive
Quantity: 10 mg in 1 1
Code: 778XL6VBS8
Classification: ACTIM
levoleucovorin injection
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code14335-340
Application NumberANDA217314
Product Classification
M
Marketing Category
C73584
G
Generic Name
levoleucovorin injection
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMay 31, 2023
FDA Product Classification
INGREDIENTS (4)
WATERInactive
Quantity: 1 mL in 1 mL
Code: 059QF0KO0R
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 8.3 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
LEVOLEUCOVORIN CALCIUMActive
Quantity: 10 mg in 1 mL
Code: 778XL6VBS8
Classification: ACTIM
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT