Leucovorin Calcium
Leucovorin Calcium for Injection, USP(For Intravenous or Intramuscular Use)
Approved
Approval ID
9d0e5356-ff39-4a8e-944c-e808a21ef4b2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 9, 2022
Manufacturers
FDA
Sagent Pharmaceuticals
DUNS: 796852890
Products 4
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
leucovorin calcium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code25021-815
Application NumberANDA200753
Product Classification
M
Marketing Category
C73584
G
Generic Name
leucovorin calcium
Product Specifications
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
Effective DateNovember 9, 2022
FDA Product Classification
INGREDIENTS (4)
leucovorin calciumActive
Quantity: 200 mg in 20 mL
Code: RPR1R4C0P4
Classification: ACTIM
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT
sodium chlorideInactive
Code: 451W47IQ8X
Classification: IACT
hydrochloric acidInactive
Code: QTT17582CB
Classification: IACT
leucovorin calcium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code25021-816
Application NumberANDA200855
Product Classification
M
Marketing Category
C73584
G
Generic Name
leucovorin calcium
Product Specifications
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
Effective DateNovember 9, 2022
FDA Product Classification
INGREDIENTS (4)
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT
leucovorin calciumActive
Quantity: 350 mg in 17.5 mL
Code: RPR1R4C0P4
Classification: ACTIM
sodium chlorideInactive
Code: 451W47IQ8X
Classification: IACT
hydrochloric acidInactive
Code: QTT17582CB
Classification: IACT
leucovorin calcium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code25021-813
Application NumberANDA200753
Product Classification
M
Marketing Category
C73584
G
Generic Name
leucovorin calcium
Product Specifications
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
Effective DateNovember 9, 2022
FDA Product Classification
INGREDIENTS (4)
sodium chlorideInactive
Code: 451W47IQ8X
Classification: IACT
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT
leucovorin calciumActive
Quantity: 50 mg in 5 mL
Code: RPR1R4C0P4
Classification: ACTIM
hydrochloric acidInactive
Code: QTT17582CB
Classification: IACT
leucovorin calcium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code25021-814
Application NumberANDA200753
Product Classification
M
Marketing Category
C73584
G
Generic Name
leucovorin calcium
Product Specifications
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
Effective DateNovember 9, 2022
FDA Product Classification
INGREDIENTS (4)
leucovorin calciumActive
Quantity: 100 mg in 10 mL
Code: RPR1R4C0P4
Classification: ACTIM
sodium chlorideInactive
Code: 451W47IQ8X
Classification: IACT
hydrochloric acidInactive
Code: QTT17582CB
Classification: IACT
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT