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LANOXIN

These highlights do not include all the information needed to use LANOXIN safely and effectively. See full prescribing information for LANOXIN. LANOXIN (digoxin) tablets, for oral use Initial U.S. Approval: 1954

Approved
Approval ID

d91e3646-4c63-4512-ab22-db39c085c4dc

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Apr 12, 2022

Manufacturers
FDA

Concordia Pharmaceuticals Inc.

DUNS: 815240092

Products 4

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

digoxin

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code59212-240
Application NumberNDA020405
Product Classification
M
Marketing Category
C73594
G
Generic Name
digoxin
Product Specifications
Route of AdministrationORAL
Effective DateAugust 19, 2020
FDA Product Classification

INGREDIENTS (6)

DIGOXINActive
Quantity: 0.0625 mg in 1 1
Code: 73K4184T59
Classification: ACTIB
STARCH, POTATOInactive
Code: 8I089SAH3T
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT

digoxin

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code59212-245
Application NumberNDA020405
Product Classification
M
Marketing Category
C73594
G
Generic Name
digoxin
Product Specifications
Route of AdministrationORAL
Effective DateAugust 19, 2020
FDA Product Classification

INGREDIENTS (6)

STARCH, POTATOInactive
Code: 8I089SAH3T
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
DIGOXINActive
Quantity: 0.1875 mg in 1 1
Code: 73K4184T59
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
D&C GREEN NO. 5Inactive
Code: 8J6RDU8L9X
Classification: IACT

digoxin

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code59212-249
Application NumberNDA020405
Product Classification
M
Marketing Category
C73594
G
Generic Name
digoxin
Product Specifications
Route of AdministrationORAL
Effective DateAugust 19, 2020
FDA Product Classification

INGREDIENTS (5)

DIGOXINActive
Quantity: 0.25 mg in 1 1
Code: 73K4184T59
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, POTATOInactive
Code: 8I089SAH3T
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT

digoxin

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code59212-242
Application NumberNDA020405
Product Classification
M
Marketing Category
C73594
G
Generic Name
digoxin
Product Specifications
Route of AdministrationORAL
Effective DateAugust 19, 2020
FDA Product Classification

INGREDIENTS (7)

DIGOXINActive
Quantity: 0.125 mg in 1 1
Code: 73K4184T59
Classification: ACTIB
STARCH, POTATOInactive
Code: 8I089SAH3T
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT

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