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
NDC Product Code25021-815
Application NumberANDA200753
Marketing CategoryC73584
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
Effective DateNovember 9, 2022
Generic Nameleucovorin calcium
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
NDC Product Code25021-816
Application NumberANDA200855
Marketing CategoryC73584
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
Effective DateNovember 9, 2022
Generic Nameleucovorin calcium
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
NDC Product Code25021-813
Application NumberANDA200753
Marketing CategoryC73584
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
Effective DateNovember 9, 2022
Generic Nameleucovorin calcium
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
NDC Product Code25021-814
Application NumberANDA200753
Marketing CategoryC73584
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
Effective DateNovember 9, 2022
Generic Nameleucovorin calcium
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