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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0054-4499
Application NumberANDA072736
Product Classification
M
Marketing Category
C73584
G
Generic Name
Leucovorin Calcium
Product Specifications
Route of AdministrationORAL
Effective DateDecember 14, 2023
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0054-4496
Application NumberANDA072733
Product Classification
M
Marketing Category
C73584
G
Generic Name
Leucovorin Calcium
Product Specifications
Route of AdministrationORAL
Effective DateDecember 14, 2023
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0054-8496
Application NumberANDA072733
Product Classification
M
Marketing Category
C73584
G
Generic Name
Leucovorin Calcium
Product Specifications
Route of AdministrationORAL
Effective DateDecember 14, 2023
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0054-4497
Application NumberANDA072734
Product Classification
M
Marketing Category
C73584
G
Generic Name
Leucovorin Calcium
Product Specifications
Route of AdministrationORAL
Effective DateDecember 14, 2023
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0054-4498
Application NumberANDA072735
Product Classification
M
Marketing Category
C73584
G
Generic Name
Leucovorin Calcium
Product Specifications
Route of AdministrationORAL
Effective DateDecember 14, 2023
FDA Product Classification
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