Leucovorin Calcium
Leucovorin Calcium Tablets USP, 5 mg, 10 mg, 15 mg and 25 mg
Approved
Approval ID
7409cdee-9093-47af-a4c4-2c55ce1b6361
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 8, 2020
Manufacturers
FDA
Ingenus Pharmaceuticals, LLC
DUNS: 833250017
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 Code50742-184
Application NumberANDA211132
Product Classification
M
Marketing Category
C73584
G
Generic Name
Leucovorin Calcium
Product Specifications
Route of AdministrationORAL
Effective DateAugust 7, 2020
FDA Product Classification
INGREDIENTS (8)
LEUCOVORIN CALCIUMActive
Quantity: 25 mg in 1 1
Code: RPR1R4C0P4
Classification: ACTIM
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
Leucovorin Calcium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50742-181
Application NumberANDA211132
Product Classification
M
Marketing Category
C73584
G
Generic Name
Leucovorin Calcium
Product Specifications
Route of AdministrationORAL
Effective DateAugust 7, 2020
FDA Product Classification
INGREDIENTS (7)
LEUCOVORIN CALCIUMActive
Quantity: 5 mg in 1 1
Code: RPR1R4C0P4
Classification: ACTIM
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
Leucovorin Calcium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50742-183
Application NumberANDA211132
Product Classification
M
Marketing Category
C73584
G
Generic Name
Leucovorin Calcium
Product Specifications
Route of AdministrationORAL
Effective DateAugust 7, 2020
FDA Product Classification
INGREDIENTS (8)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
LEUCOVORIN CALCIUMActive
Quantity: 15 mg in 1 1
Code: RPR1R4C0P4
Classification: ACTIM
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
Leucovorin Calcium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50742-182
Application NumberANDA211132
Product Classification
M
Marketing Category
C73584
G
Generic Name
Leucovorin Calcium
Product Specifications
Route of AdministrationORAL
Effective DateAugust 7, 2020
FDA Product Classification
INGREDIENTS (7)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
LEUCOVORIN CALCIUMActive
Quantity: 10 mg in 1 1
Code: RPR1R4C0P4
Classification: ACTIM
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT