NDC Code(s) : 68462-162-60, 68462-162-01, 68462-162-18, 68462-162-05, 68462-162-10, 68462-163-60, 68462-163-01, 68462-163-18, 68462-163-05, 68462-163-10, 68462-164-60, 68462-164-01, 68462-164-18, 68462-164-05, 68462-164-10, 68462-165-60, 68462-165-01, 68462-165-18, 68462-165-05, 68462-165-10
Packager : Glenmark Pharmaceuticals Inc., USA

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:68462-162
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 (120 .MU.M)(UNII: 68401960MK)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
LACTOSE, UNSPECIFIED FORM(UNII: J2B2A4N98G)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
POVIDONE, UNSPECIFIED(UNII: FZ989GH94E)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 5 mm
Flavor Imprint Code G
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68462-162-6060 in 1 BOTTLE Type 0: Not a Combination Product09/05/2007
2NDC:68462-162-01100 in 1 BOTTLE Type 0: Not a Combination Product09/05/2007
3NDC:68462-162-18180 in 1 BOTTLE Type 0: Not a Combination Product12/10/2014
4NDC:68462-162-05500 in 1 BOTTLE Type 0: Not a Combination Product09/05/2007
5NDC:68462-162-101000 in 1 BOTTLE Type 0: Not a Combination Product09/05/2007
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078251 09/05/2007
CarvedilolCarvedilol TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68462-163
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 (120 .MU.M)(UNII: 68401960MK)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
LACTOSE, UNSPECIFIED FORM(UNII: J2B2A4N98G)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
POVIDONE, UNSPECIFIED(UNII: FZ989GH94E)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 6 mm
Flavor Imprint Code G;41
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68462-163-6060 in 1 BOTTLE Type 0: Not a Combination Product09/05/2007
2NDC:68462-163-01100 in 1 BOTTLE Type 0: Not a Combination Product09/05/2007
3NDC:68462-163-18180 in 1 BOTTLE Type 0: Not a Combination Product12/10/2014
4NDC:68462-163-05500 in 1 BOTTLE Type 0: Not a Combination Product09/05/2007
5NDC:68462-163-101000 in 1 BOTTLE Type 0: Not a Combination Product09/05/2007
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078251 09/05/2007
CarvedilolCarvedilol TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68462-164
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 (120 .MU.M)(UNII: 68401960MK)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
LACTOSE, UNSPECIFIED FORM(UNII: J2B2A4N98G)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
POVIDONE, UNSPECIFIED(UNII: FZ989GH94E)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color WHITE Score no score
Shape OVAL (capsule shaped) Size 10 mm
Flavor Imprint Code G;164
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68462-164-6060 in 1 BOTTLE Type 0: Not a Combination Product09/05/2007
2NDC:68462-164-01100 in 1 BOTTLE Type 0: Not a Combination Product09/05/2007
3NDC:68462-164-18180 in 1 BOTTLE Type 0: Not a Combination Product12/10/2014
4NDC:68462-164-05500 in 1 BOTTLE Type 0: Not a Combination Product09/05/2007
5NDC:68462-164-101000 in 1 BOTTLE Type 0: Not a Combination Product09/05/2007
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078251 09/05/2007
CarvedilolCarvedilol TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68462-165
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 (120 .MU.M)(UNII: 68401960MK)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
LACTOSE, UNSPECIFIED FORM(UNII: J2B2A4N98G)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
POVIDONE, UNSPECIFIED(UNII: FZ989GH94E)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 10 mm
Flavor Imprint Code G41;25
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68462-165-6060 in 1 BOTTLE Type 0: Not a Combination Product09/05/2007
2NDC:68462-165-01100 in 1 BOTTLE Type 0: Not a Combination Product09/05/2007
3NDC:68462-165-18180 in 1 BOTTLE Type 0: Not a Combination Product12/10/2014
4NDC:68462-165-05500 in 1 BOTTLE Type 0: Not a Combination Product09/05/2007
5NDC:68462-165-101000 in 1 BOTTLE Type 0: Not a Combination Product09/05/2007
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078251 09/05/2007

LABELER - Glenmark Pharmaceuticals Inc., USA(130597813)

Establishment
Name Address ID/FEI Business Operations
Glenmark Pharmaceuticals Limited 677318665 ANALYSIS(68462-162, 68462-163, 68462-164, 68462-165), MANUFACTURE(68462-162, 68462-163, 68462-164, 68462-165)

Establishment
Name Address ID/FEI Business Operations
Glenmark Pharmaceuticals Limited 862603186 ANALYSIS(68462-162, 68462-163, 68462-164, 68462-165), MANUFACTURE(68462-162, 68462-163, 68462-164, 68462-165)

PRINCIPAL DISPLAY PANEL

NDC 68462-162-01
CARVEDILOL
TABLETS USP
3.125 mg-100 Tablets
label3125mg100s

PRINCIPAL DISPLAY PANEL

NDC 68462-163-01
CARVEDILOL
TABLETS USP
6.25 mg-100 Tablets

label625mg100s

PRINCIPAL DISPLAY PANEL


NDC 68462-164-01
CARVEDILOL
TABLETS USP
12.5 mg-100 Tablets

label125mg100s

PRINCIPAL DISPLAY PANEL

NDC 68462-165-01
CARVEDILOL
TABLETS USP
25 mg-100 Tablets

label25mg100s