LANOXIN (Page 9 of 9)

PRINCIPAL DISPLAY PANEL — 250 mcg

lanoxin-250-mcg-100-bottle
(click image for full-size original)

NDC 59212-249-55 100 Tablets

Lanoxin®
(digoxin) Tablets, USP

250 mcg (0.25 mg)

Each scored tablet contains 250 mcg (0.25 mg).
CONCORDIA PHARMACEUTICALS

Mfd. for: Concordia Pharmaceuticals
Distributed by:
Amdipharm Limited,
17 Northwood House, Dublin 9, Ireland Made in Germany RX only

lanoxin-250mcg-100-bottle
(click image for full-size original)

NDC 59212-249-56 UNIT DOSE PACK
100 Tablets (10 blisterpacks of 10 tablets each)

Lanoxin®
(digoxin) Tablets, USP

250 mcg (0.25 mg)

Each scored tablet contains 250 mcg (0.25 mg) digoxin.

This unit dose packaging is intended for institutional inpatient use. If dispensed for outpatient use, an appropriate safety closure should be provided.

RX only

See prescribing information for dosage information.

LANOXIN digoxin tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59212-242
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIGOXIN (DIGOXIN) DIGOXIN 0.125 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, POTATO
STARCH, CORN
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
D&C YELLOW NO. 10
FD&C YELLOW NO. 6
Product Characteristics
Color YELLOW Score 2 pieces
Shape ROUND Size 6mm
Flavor Imprint Code LANOXIN;Y3B
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59212-242-55 100 TABLET in 1 BOTTLE None
2 NDC:59212-242-56 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
2 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (59212-242-56)
3 NDC:59212-242-75 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020405 09/30/2012
LANOXIN digoxin tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59212-249
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIGOXIN (DIGOXIN) DIGOXIN 0.25 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, POTATO
STARCH, CORN
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
Product Characteristics
Color WHITE Score 2 pieces
Shape ROUND Size 7mm
Flavor Imprint Code LANOXIN;X3A
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59212-249-55 100 TABLET in 1 BOTTLE None
2 NDC:59212-249-56 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
2 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (59212-249-56)
3 NDC:59212-249-75 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020405 09/30/2012
LANOXIN digoxin tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59212-240
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIGOXIN (DIGOXIN) DIGOXIN 0.0625 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, POTATO
STARCH, CORN
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
FD&C YELLOW NO. 6
Product Characteristics
Color ORANGE (Peach) Score no score
Shape ROUND Size 5mm
Flavor Imprint Code LANOXIN;U3A
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59212-240-55 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020405 09/30/2012
LANOXIN digoxin tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59212-245
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIGOXIN (DIGOXIN) DIGOXIN 0.1875 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, POTATO
STARCH, CORN
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
D&C GREEN NO. 5
Product Characteristics
Color BLUE Score no score
Shape ROUND Size 6mm
Flavor Imprint Code LANOXIN;F3F
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59212-245-55 100 TABLET in 1 BOTTLE None
2 NDC:59212-245-75 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020405 09/30/2012 09/30/2019
Labeler — Concordia Pharmaceuticals Inc. (860243190)

Revised: 04/2020 Concordia Pharmaceuticals Inc.

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