Leucovorin Calcium
Leucovorin Calcium Tablets, USP 5 mg, 10 mg, 15 mg and 25 mg Rx only
Approved
Approval ID
2627a485-05b5-4dab-ac20-dc840e5c469d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 8, 2023
Manufacturers
FDA
Epic Pharma LLC
DUNS: 827915443
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 Code42806-358
Application NumberANDA074544
Product Classification
M
Marketing Category
C73584
G
Generic Name
Leucovorin Calcium
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 21, 2023
FDA Product Classification
INGREDIENTS (6)
LEUCOVORIN CALCIUMActive
Quantity: 5 mg in 1 1
Code: RPR1R4C0P4
Classification: ACTIM
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM PALMITOSTEARATEInactive
Code: R4OXA9G5BV
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
Leucovorin Calcium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42806-359
Application NumberANDA074544
Product Classification
M
Marketing Category
C73584
G
Generic Name
Leucovorin Calcium
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 21, 2023
FDA Product Classification
INGREDIENTS (6)
LEUCOVORIN CALCIUMActive
Quantity: 25 mg in 1 1
Code: RPR1R4C0P4
Classification: ACTIM
MAGNESIUM PALMITOSTEARATEInactive
Code: R4OXA9G5BV
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
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 Code42806-134
Application NumberANDA074544
Product Classification
M
Marketing Category
C73584
G
Generic Name
Leucovorin Calcium
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 21, 2023
FDA Product Classification
INGREDIENTS (6)
LEUCOVORIN CALCIUMActive
Quantity: 15 mg in 1 1
Code: RPR1R4C0P4
Classification: ACTIM
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM PALMITOSTEARATEInactive
Code: R4OXA9G5BV
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
Leucovorin Calcium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42806-133
Application NumberANDA074544
Product Classification
M
Marketing Category
C73584
G
Generic Name
Leucovorin Calcium
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 21, 2023
FDA Product Classification
INGREDIENTS (6)
LEUCOVORIN CALCIUMActive
Quantity: 10 mg in 1 1
Code: RPR1R4C0P4
Classification: ACTIM
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM PALMITOSTEARATEInactive
Code: R4OXA9G5BV
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT