LEUCOVORIN CALCIUM
Leucovorin Calcium Tablets USP 5 mg, 10 mg, 15 mg and 25 mgRx only
Approved
Approval ID
c8102043-79f2-421a-b849-94bac19007a6
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 11, 2023
Manufacturers
FDA
Leading Pharma, LLC
DUNS: 079575060
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 Code69315-185
Application NumberANDA213929
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateSeptember 11, 2023
Generic NameLEUCOVORIN CALCIUM
INGREDIENTS (6)
LEUCOVORIN CALCIUMActive
Quantity: 10 mg in 1 1
Code: RPR1R4C0P4
Classification: ACTIM
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
LEUCOVORIN CALCIUM
PRODUCT DETAILS
NDC Product Code69315-187
Application NumberANDA213929
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateSeptember 11, 2023
Generic NameLEUCOVORIN CALCIUM
INGREDIENTS (6)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
LEUCOVORIN CALCIUMActive
Quantity: 25 mg in 1 1
Code: RPR1R4C0P4
Classification: ACTIM
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
LEUCOVORIN CALCIUM
PRODUCT DETAILS
NDC Product Code69315-186
Application NumberANDA213929
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateSeptember 11, 2023
Generic NameLEUCOVORIN CALCIUM
INGREDIENTS (6)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
LEUCOVORIN CALCIUMActive
Quantity: 15 mg in 1 1
Code: RPR1R4C0P4
Classification: ACTIM
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
LEUCOVORIN CALCIUM
PRODUCT DETAILS
NDC Product Code69315-184
Application NumberANDA213929
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateSeptember 11, 2023
Generic NameLEUCOVORIN CALCIUM
INGREDIENTS (6)
LEUCOVORIN CALCIUMActive
Quantity: 5 mg in 1 1
Code: RPR1R4C0P4
Classification: ACTIM
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT