LANOXIN (Page 8 of 8)

PRINCIPAL DISPLAY PANEL — Pediatric Carton Label — Vial

Principal Display Panel -- Pediatric Carton Label -- Vial
(click image for full-size original)

Pediatric Carton label — Vial

NDC 70515-263-10 10 vials 1 mL each Rx only

LANOXIN® (digoxin) Injection
Pediatric

100 mcg (0.1 mg) In 1 mL

C O V I S

NDC 70515-263-10 10 vials 1 mL each
LANOXIN® (digoxin) Injection Pediatric
100 mcg (0.1 mg) in 1 mL

A sterile solution for intravenous or intramuscular injection. Dilution
not required. In a vehicle of 40% propylene glycol and 10% alcohol.
Sodium phosphate 0.17%. Citric acid anhydrous 0.08%.

See prescribing information for dosage information.

Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F)
[see USP Controlled Room Temperature] and protect from light.

GTIN XXXXXXXXXXXXXX
S/N XXXXXXXXXXXX

Lot XXXXXX
Exp MMM YYYY

Manufactured for
Covis Pharma
Zug, 6300 Switzerland

Made in Germany©2019, Covis Pharma

LANOXIN digoxin injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70515-260
Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIGOXIN (DIGOXIN) DIGOXIN 250 ug in 1 mL
Inactive Ingredients
Ingredient Name Strength
PROPYLENE GLYCOL
ALCOHOL
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM
ANHYDROUS CITRIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70515-260-10 10 AMPULE in 1 BOX contains a AMPULE
1 2 mL in 1 AMPULE This package is contained within the BOX (70515-260-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA009330 09/15/2017
LANOXIN digoxin injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70515-261
Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIGOXIN (DIGOXIN) DIGOXIN 250 ug in 1 mL
Inactive Ingredients
Ingredient Name Strength
PROPYLENE GLYCOL
ALCOHOL
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM
ANHYDROUS CITRIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70515-261-10 10 VIAL in 1 BOX contains a VIAL
1 2 mL in 1 VIAL This package is contained within the BOX (70515-261-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA009330 10/29/2019
LANOXIN digoxin injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70515-262
Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIGOXIN (DIGOXIN) DIGOXIN 100 ug in 1 mL
Inactive Ingredients
Ingredient Name Strength
PROPYLENE GLYCOL
ALCOHOL
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM
ANHYDROUS CITRIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70515-262-10 10 AMPULE in 1 BOX contains a AMPULE
1 1 mL in 1 AMPULE This package is contained within the BOX (70515-262-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA009330 09/15/2017
LANOXIN digoxin injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70515-263
Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIGOXIN (DIGOXIN) DIGOXIN 100 ug in 1 mL
Inactive Ingredients
Ingredient Name Strength
PROPYLENE GLYCOL
ALCOHOL
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM
ANHYDROUS CITRIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70515-263-10 10 VIAL in 1 BOX contains a VIAL
1 1 mL in 1 VIAL This package is contained within the BOX (70515-263-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA009330 10/29/2019
Labeler — Covis Pharma (486209070)

Revised: 10/2019 Covis Pharma

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