NDC Code(s) : 0003-1611-12, 0003-1611-13, 0003-1612-12, 0003-1614-12
Packager : E.R. Squibb & Sons, L.L.C.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

BARACLUDEentecavir TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0003-1611
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ENTECAVIR(UNII: 5968Y6H45M)
(entecavir anhydrous - UNII:NNU2O4609D) 		ENTECAVIR0.5 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
CROSPOVIDONE (15 MPA.S AT 5%)(UNII: 68401960MK)
POVIDONE, UNSPECIFIED(UNII: FZ989GH94E)
MAGNESIUM STEARATE(UNII: 70097M6I30)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
Product Characteristics
Color WHITE Score no score
Shape TRIANGLE Size 8 mm
Flavor Imprint Code BMS;1611
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0003-1611-121 in 1 CARTON 29/03/2005
130 in 1 BOTTLE Type 0: Not a Combination Product
2NDC:0003-1611-131 in 1 CARTON 29/03/2005
290 in 1 BOTTLE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021797 03/29/2005
BARACLUDEentecavir TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0003-1612
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ENTECAVIR(UNII: 5968Y6H45M)
(entecavir anhydrous - UNII:NNU2O4609D) 		ENTECAVIR1.0 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
CROSPOVIDONE (15 MPA.S AT 5%)(UNII: 68401960MK)
POVIDONE, UNSPECIFIED(UNII: FZ989GH94E)
MAGNESIUM STEARATE(UNII: 70097M6I30)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
FERRIC OXIDE RED(UNII: 1K09F3G675)
Product Characteristics
Color PINK Score no score
Shape TRIANGLE Size 10 mm
Flavor Imprint Code BMS;1612
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0003-1612-121 in 1 CARTON 29/03/2005
130 in 1 BOTTLE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021797 03/29/2005
BARACLUDEentecavir SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0003-1614
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ENTECAVIR(UNII: 5968Y6H45M)
(entecavir anhydrous - UNII:NNU2O4609D) 		ENTECAVIR0.05 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
MALTITOL(UNII: D65DG142WK)
SODIUM CITRATE, UNSPECIFIED FORM(UNII: 1Q73Q2JULR)
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
METHYLPARABEN(UNII: A2I8C7HI9T)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0003-1614-121 in 1 CARTON 29/03/2005
1210 mL in 1 BOTTLE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021798 03/29/2005

LABELER - E.R. Squibb & Sons, L.L.C.(011550092)

PRINCIPAL DISPLAY PANEL

See HOW SUPPLIED section for a complete list of available packages of BARACLUDE.

30 Tablets NDC 0003-1611-12
Baraclude®
(entecavir)
Tablets
0.5 mg
Bristol-Myers Squibb
Rx only

barac-30ct-halfmg-car

PRINCIPAL DISPLAY PANEL

30 Tablets NDC 0003-1612-12
Baraclude®
(entecavir)
Tablets
1 mg
Bristol-Myers Squibb
Rx only

barac-30ct-1mg-car

PRINCIPAL DISPLAY PANEL

210 mL NDC 0003-1614-12
Baraclude®
(entecavir)
Oral Solution
0.05 mg/mL
Store Bottle in Carton to Protect from Light
Bristol-Myers Squibb
Rx only

barac-os-halfmgml-car