Entecavir (Page 8 of 8)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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ENTECAVIR entecavir tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42291-261
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ENTECAVIR (ENTECAVIR ANHYDROUS) ENTECAVIR 0.5 mg
Inactive Ingredients
Ingredient Name Strength
CROSPOVIDONE (12 MPA.S AT 5%)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
HYPROMELLOSES
POLYETHYLENE GLYCOL 8000
TITANIUM DIOXIDE
POVIDONE
Product Characteristics
Color white (white to off-white) Score no score
Shape OVAL Size 10mm
Flavor Imprint Code AN;446
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42291-261-30 30 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206652 11/02/2020
ENTECAVIR entecavir tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42291-262
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ENTECAVIR (ENTECAVIR ANHYDROUS) ENTECAVIR 1 mg
Inactive Ingredients
Ingredient Name Strength
CROSPOVIDONE (12 MPA.S AT 5%)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
HYPROMELLOSES
FERRIC OXIDE RED
POLYETHYLENE GLYCOL 8000
TITANIUM DIOXIDE
POVIDONE
Product Characteristics
Color pink Score no score
Shape OVAL Size 14mm
Flavor Imprint Code AN;449
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42291-262-30 30 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206652 11/02/2020
Labeler — AvKARE (796560394)

Revised: 01/2024 AvKARE

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