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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69315-185
Application NumberANDA213929
Product Classification
M
Marketing Category
C73584
G
Generic Name
LEUCOVORIN CALCIUM
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 11, 2023
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69315-187
Application NumberANDA213929
Product Classification
M
Marketing Category
C73584
G
Generic Name
LEUCOVORIN CALCIUM
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 11, 2023
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69315-186
Application NumberANDA213929
Product Classification
M
Marketing Category
C73584
G
Generic Name
LEUCOVORIN CALCIUM
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 11, 2023
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69315-184
Application NumberANDA213929
Product Classification
M
Marketing Category
C73584
G
Generic Name
LEUCOVORIN CALCIUM
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 11, 2023
FDA Product Classification
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