NDC Code(s) : 24987-242-55, 24987-242-75, 24987-242-56, 24987-242-57, 24987-242-76, 24987-249-55, 24987-249-75, 24987-249-56, 24987-249-57, 24987-249-76, 24987-240-55, 24987-240-75, 24987-245-55, 24987-245-75
Packager : Covis Pharmaceuticals, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

LANOXINdigoxin TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:24987-242
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIGOXIN(UNII: 73K4184T59)
(DIGOXIN - UNII:73K4184T59) 		DIGOXIN0.125 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, POTATO(UNII: 8I089SAH3T)
STARCH, CORN(UNII: O8232NY3SJ)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
Product Characteristics
Color YELLOW Score 2 pieces
Shape ROUND Size 6 mm
Flavor Imprint Code LANOXIN;Y3B
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:24987-242-55100 in 1 BOTTLE Type 0: Not a Combination Product30/09/2012
2NDC:24987-242-751000 in 1 BOTTLE Type 0: Not a Combination Product30/09/2012
3NDC:24987-242-5610 in 1 CARTON 30/09/2012
310 in 1 BLISTER PACK Type 0: Not a Combination Product30/09/2012
4NDC:24987-242-57100 in 1 BOTTLE Type 0: Not a Combination Product30/09/2012
5NDC:24987-242-761000 in 1 BOTTLE Type 0: Not a Combination Product30/09/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020405 09/30/2012 11/30/2018
LANOXINdigoxin TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:24987-249
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIGOXIN(UNII: 73K4184T59)
(DIGOXIN - UNII:73K4184T59) 		DIGOXIN0.25 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, POTATO(UNII: 8I089SAH3T)
STARCH, CORN(UNII: O8232NY3SJ)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
Product Characteristics
Color WHITE Score 2 pieces
Shape ROUND Size 7 mm
Flavor Imprint Code LANOXIN;X3A
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:24987-249-55100 in 1 BOTTLE Type 0: Not a Combination Product30/09/2012
2NDC:24987-249-751000 in 1 BOTTLE Type 0: Not a Combination Product30/09/2012
3NDC:24987-249-5610 in 1 CARTON 30/09/2012
310 in 1 BLISTER PACK Type 0: Not a Combination Product30/09/2012
4NDC:24987-249-57100 in 1 BOTTLE Type 0: Not a Combination Product30/09/2012
5NDC:24987-249-761000 in 1 BOTTLE Type 0: Not a Combination Product30/09/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020405 09/30/2012 12/31/2018
LANOXINdigoxin TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:24987-240
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIGOXIN(UNII: 73K4184T59)
(DIGOXIN - UNII:73K4184T59) 		DIGOXIN0.0625 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, POTATO(UNII: 8I089SAH3T)
STARCH, CORN(UNII: O8232NY3SJ)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
Product Characteristics
Color ORANGE (Peach) Score no score
Shape ROUND Size 5 mm
Flavor Imprint Code LANOXIN;U3A
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:24987-240-55100 in 1 BOTTLE Type 0: Not a Combination Product30/09/2012
2NDC:24987-240-751000 in 1 BOTTLE Type 0: Not a Combination Product30/09/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020405 09/30/2012 09/30/2017
LANOXINdigoxin TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:24987-245
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIGOXIN(UNII: 73K4184T59)
(DIGOXIN - UNII:73K4184T59) 		DIGOXIN0.1875 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, POTATO(UNII: 8I089SAH3T)
STARCH, CORN(UNII: O8232NY3SJ)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
D&C GREEN NO. 5(UNII: 8J6RDU8L9X)
Product Characteristics
Color BLUE Score no score
Shape ROUND Size 6 mm
Flavor Imprint Code LANOXIN;F3F
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:24987-245-55100 in 1 BOTTLE Type 0: Not a Combination Product30/09/2012
2NDC:24987-245-751000 in 1 BOTTLE Type 0: Not a Combination Product30/09/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020405 09/30/2012 09/30/2016

PRINCIPAL DISPLAY PANEL

62.5 MCG TABLET62.5 mcg Tablet

NDC 24987-240-55     100 Tablets

LANOXIN®
(digoxin) Tablets, USP

62.5 mcg (0.0625 mg)

Each tablet contains
62.5 mcg (0.0625 mg).

Dist. by Covis Pharmaceuticals, Inc.
Cary, NC 27511
Mfd. by Patheon Manufacturing Services LLC.
Greenville, NC 27834

Made in Germany          Rx only

100194          Rev. 9/14

See prescribing information for dosage information.
Store at 25°C (77°F) in a dry place and protect from
light (see insert).
Dispense in tight, light-resistant container as defined
in the USP. Keep out of reach of children.
Do not use if printed safety seal under cap
is broken or missing.

Lot/Exp Area

PRINCIPAL DISPLAY PANEL

125 mcg Tablet Label125 mcg Tablet

NDC 24987-242-55     100 Tablets

LANOXIN®
(digoxin) Tablets, USP

125 mcg (0.125 mg)

Each scored tablet contains
125 mcg (0.125 mg).

Dist. by Covis Pharmaceuticals, Inc.
Cary, NC 27511
Mfd. by Patheon Manufacturing Services LLC.
Greenville, NC 27834

Made in Germany          Rx only

100190          Rev. 9/14

See prescribing information for dosage information.
Store at 25°C (77°F) in a dry place and protect from
light (see insert).
Dispense in tight, light-resistant container as defined
in the USP. Keep out of reach of children.
Do not use if printed safety seal under cap is
broken or missing.

Lot/Exp Area

PRINCIPAL DISPLAY PANEL

187.5 mcg Tablet Label187.5 mcg Tablet

NDC 24987-245-55     100 Tablets

LANOXIN®
(digoxin) Tablets, USP

187.5 mcg (0.1875 mg)

Each tablet contains
187.5 mcg (0.1875 mg).

Dist. by Covis Pharmaceuticals, Inc.
Cary, NC 27511
Mfd. by Patheon Manufacturing Services LLC.
Greenville, NC 27834

Made in Germany          Rx only

100195          Rev. 9/14

See prescribing information for dosage information.
Store at 25°C (77°F) in a dry place and protect from
light (see insert).
Dispense in tight, light-resistant container as defined
in the USP. Keep out of reach of children.
Do not use if printed safety seal under cap
is broken or missing.

Lot/Exp Area

PRINCIPAL DISPLAY PANEL

250 mcg Tablet Label250 mcg Tablet

NDC 24987-249-55     100 Tablets

LANOXIN®
(digoxin) Tablets, USP

250 mcg (0.25 mg)

Each scored tablet contains
250 mcg (0.25 mg).

Dist. by Covis Pharmaceuticals, Inc.
Cary, NC 27511
Mfd. by Patheon Manufacturing Services LLC.
Greenville, NC 27834

Made in Germany          Rx only

100192          Rev. 9/14

See prescribing information for dosage information.
Store at 25°C (77°F) in a dry place and protect from
light (see insert).
Dispense in tight, light-resistant container as defined
in the USP. Keep out of reach of children.
Do not use if printed safety seal under cap
is broken or missing.

Lot/Exp Area

PRINCIPAL DISPLAY PANEL

125 mcg Tablet - Government Use Only125 mcg Tablet Government Use Only

NDC 24987-242-57     100 Tablets

LANOXIN®
(digoxin) Tablets, USP

125 mcg (0.125 mg)

Each scored tablet contains
125 mcg (0.125 mg).

GOVERNMENT USE ONLY

Dist. by Covis Pharmaceuticals, Inc.
Cary, NC 27511
Mfd. by Patheon Manufacturing Services LLC.
Greenville, NC 27834

Made in Germany          Rx only

100196          Rev. 9/14

See prescribing information for dosage information.
Store at 25°C (77°F) in a dry place and protect from
light (see insert).
Dispense in tight, light-resistant container as defined
in the USP. Keep out of reach of children.
Do not use if printed safety seal under cap is
broken or missing.

Lot/Exp Area

PRINCIPAL DISPLAY PANEL

250 mcg Tablet - Government Use Only250 mcg Tablet Government Use Only

NDC 24987-249-57     100 Tablets

LANOXIN®
(digoxin) Tablets, USP

250 mcg (0.25 mg)

Each scored tablet contains
250 mcg (0.25 mg).

GOVERNMENT USE ONLY

Dist. by Covis Pharmaceuticals, Inc.
Cary, NC 27511
Mfd. by Patheon Manufacturing Services LLC.
Greenville, NC 27834

Made in Germany          Rx only

100198          Rev. 9/14

See prescribing information for dosage information.
Store at 25°C (77°F) in a dry place and protect from
light (see insert).
Dispense in tight, light-resistant container as defined
in the USP. Keep out of reach of children.
Do not use if printed safety seal under cap
is broken or missing.

Lot/Exp Area