Leucovorin Calcium
Leucovorin Calcium Tablets USP, 5 mg, 10 mg, 15 mg, and 25 mg
Approved
Approval ID
33663425-4731-4977-9127-9e59b6b91497
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 14, 2023
Manufacturers
FDA
Hikma Pharmaceuticals USA Inc.
DUNS: 080189610
Products 5
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 Code0054-4499
Application NumberANDA072736
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateDecember 14, 2023
Generic NameLeucovorin Calcium
INGREDIENTS (8)
LEUCOVORIN CALCIUMActive
Quantity: 25 mg in 1 1
Code: RPR1R4C0P4
Classification: ACTIM
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
Leucovorin Calcium
PRODUCT DETAILS
NDC Product Code0054-4496
Application NumberANDA072733
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateDecember 14, 2023
Generic NameLeucovorin Calcium
INGREDIENTS (7)
LEUCOVORIN CALCIUMActive
Quantity: 5 mg in 1 1
Code: RPR1R4C0P4
Classification: ACTIM
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
Leucovorin Calcium
PRODUCT DETAILS
NDC Product Code0054-8496
Application NumberANDA072733
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateDecember 14, 2023
Generic NameLeucovorin Calcium
INGREDIENTS (7)
LEUCOVORIN CALCIUMActive
Quantity: 5 mg in 1 1
Code: RPR1R4C0P4
Classification: ACTIM
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
Leucovorin Calcium
PRODUCT DETAILS
NDC Product Code0054-4497
Application NumberANDA072734
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateDecember 14, 2023
Generic NameLeucovorin Calcium
INGREDIENTS (7)
LEUCOVORIN CALCIUMActive
Quantity: 10 mg in 1 1
Code: RPR1R4C0P4
Classification: ACTIM
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
Leucovorin Calcium
PRODUCT DETAILS
NDC Product Code0054-4498
Application NumberANDA072735
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateDecember 14, 2023
Generic NameLeucovorin Calcium
INGREDIENTS (8)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
LEUCOVORIN CALCIUMActive
Quantity: 15 mg in 1 1
Code: RPR1R4C0P4
Classification: ACTIM