NDC Code(s) : 76385-110-01, 76385-110-50, 76385-111-01, 76385-111-50, 76385-112-01, 76385-112-50, 76385-113-01, 76385-113-50
Packager : Bayshore Pharmaceuticals LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

CarvedilolCarvedilol Tablet, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:76385-110
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CARVEDILOL(UNII: 0K47UL67F2)
(CARVEDILOL - UNII:0K47UL67F2) 		CARVEDILOL3.125 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CROSPOVIDONE(UNII: 2S7830E561)
HYPROMELLOSES(UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
SODIUM CITRATE(UNII: 1Q73Q2JULR)
SUCROSE(UNII: C151H8M554)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color white Score no score
Shape OVAL (Biconvex) Size 6 mm
Flavor Imprint Code 254
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:76385-110-01100 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product10/01/2016
2NDC:76385-110-50500 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product10/01/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078384 10/01/2016
CarvedilolCarvedilol Tablet, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:76385-111
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CARVEDILOL(UNII: 0K47UL67F2)
(CARVEDILOL - UNII:0K47UL67F2) 		CARVEDILOL6.25 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CROSPOVIDONE(UNII: 2S7830E561)
HYPROMELLOSES(UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
SODIUM CITRATE(UNII: 1Q73Q2JULR)
SUCROSE(UNII: C151H8M554)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color white Score no score
Shape OVAL (Biconvex) Size 9 mm
Flavor Imprint Code 255
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:76385-111-01100 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product10/01/2016
2NDC:76385-111-50500 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product10/01/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078384 10/01/2016
CarvedilolCarvedilol Tablet, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:76385-112
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CARVEDILOL(UNII: 0K47UL67F2)
(CARVEDILOL - UNII:0K47UL67F2) 		CARVEDILOL12.5 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CROSPOVIDONE(UNII: 2S7830E561)
HYPROMELLOSES(UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
SODIUM CITRATE(UNII: 1Q73Q2JULR)
SUCROSE(UNII: C151H8M554)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color white Score no score
Shape OVAL (Biconvex) Size 12 mm
Flavor Imprint Code 256
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:76385-112-01100 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product10/01/2016
2NDC:76385-112-50500 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product10/01/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078384 10/01/2016
CarvedilolCarvedilol Tablet, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:76385-113
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CARVEDILOL(UNII: 0K47UL67F2)
(CARVEDILOL - UNII:0K47UL67F2) 		CARVEDILOL25 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CROSPOVIDONE(UNII: 2S7830E561)
HYPROMELLOSES(UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
SODIUM CITRATE(UNII: 1Q73Q2JULR)
SUCROSE(UNII: C151H8M554)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color white Score no score
Shape OVAL (Biconvex) Size 15 mm
Flavor Imprint Code 257
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:76385-113-01100 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product10/01/2016
2NDC:76385-113-50500 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product10/01/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078384 10/01/2016

LABELER - Bayshore Pharmaceuticals LLC(968737416)

REGISTRANT - Beximco Pharmaceuticals USA Inc(731557430)

Establishment
Name Address ID/FEI Business Operations
Beximco Pharmaceuticals Ltd 731579053 manufacture(76385-110, 76385-111, 76385-112, 76385-113)

PRINCIPAL DISPLAY PANEL

NDC 76385-110-01      Rx only

Carvedilol Tablet
Tablet USP

3.125 mg

100 Tablet

Bayshore

PRINCIPAL DISPLAY PANEL - 3.125 mg container

PRINCIPAL DISPLAY PANEL

NDC 76385-111-01      Rx only

Carvedilol Tablet
Tablet USP

6.25 mg

100 Tablet

Bayshore

PRINCIPAL DISPLAY PANEL - 6.25 mg container

PRINCIPAL DISPLAY PANEL

NDC 76385-112-01      Rx only

Carvedilol Tablet
Tablet USP

12.5 mg

100 Tablet

Bayshore

PRINCIPAL DISPLAY PANEL - 12.5 mg container

PRINCIPAL DISPLAY PANEL

NDC 76385-113-01      Rx only

Carvedilol Tablet
Tablet USP

25 mg

100 Tablet

Bayshore

PRINCIPAL DISPLAY PANEL - 25 mg container