Carvedilol (Page 9 of 9)

Package/Label Display Panel

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

label3125mg100s
(click image for full-size original)

Package/Label Display Panel

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

label625mg100s
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NDC 68462-164-01
CARVEDILOL
TABLETS USP 12.5 mg –100 Tablets

label125mg100s
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NDC 68462-165-01
CARVEDILOL
TABLETS USP 25 mg –100 Tablets

label25mg100s
(click image for full-size original)
CARVEDILOL carvedilol 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 (CARVEDILOL) CARVEDILOL 3.125 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSPOVIDONE (120 .MU.M)
HYPROMELLOSE, UNSPECIFIED
LACTOSE, UNSPECIFIED FORM
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYSORBATE 80
POVIDONE, UNSPECIFIED
TITANIUM DIOXIDE
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 5mm
Flavor Imprint Code G
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68462-162-60 60 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:68462-162-01 100 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:68462-162-18 180 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:68462-162-05 500 TABLET, FILM COATED in 1 BOTTLE None
5 NDC:68462-162-10 1000 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078251 09/05/2007
CARVEDILOL carvedilol 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 (CARVEDILOL) CARVEDILOL 6.25 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSPOVIDONE (120 .MU.M)
HYPROMELLOSE, UNSPECIFIED
LACTOSE, UNSPECIFIED FORM
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYSORBATE 80
POVIDONE, UNSPECIFIED
TITANIUM DIOXIDE
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 6mm
Flavor Imprint Code G;41
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68462-163-60 60 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:68462-163-01 100 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:68462-163-18 180 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:68462-163-05 500 TABLET, FILM COATED in 1 BOTTLE None
5 NDC:68462-163-10 1000 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078251 09/05/2007
CARVEDILOL carvedilol 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 (CARVEDILOL) CARVEDILOL 12.5 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSPOVIDONE (120 .MU.M)
HYPROMELLOSE, UNSPECIFIED
LACTOSE, UNSPECIFIED FORM
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYSORBATE 80
POVIDONE, UNSPECIFIED
TITANIUM DIOXIDE
Product Characteristics
Color WHITE Score no score
Shape OVAL (capsule shaped) Size 10mm
Flavor Imprint Code G;164
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68462-164-60 60 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:68462-164-01 100 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:68462-164-18 180 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:68462-164-05 500 TABLET, FILM COATED in 1 BOTTLE None
5 NDC:68462-164-10 1000 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078251 09/05/2007
CARVEDILOL carvedilol 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 (CARVEDILOL) CARVEDILOL 25 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSPOVIDONE (120 .MU.M)
HYPROMELLOSE, UNSPECIFIED
LACTOSE, UNSPECIFIED FORM
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYSORBATE 80
POVIDONE, UNSPECIFIED
TITANIUM DIOXIDE
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 10mm
Flavor Imprint Code G41;25
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68462-165-60 60 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:68462-165-01 100 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:68462-165-18 180 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:68462-165-05 500 TABLET, FILM COATED in 1 BOTTLE None
5 NDC:68462-165-10 1000 TABLET, FILM COATED in 1 BOTTLE None
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 Operations
Glenmark Pharmaceuticals Limited 677318665 ANALYSIS (68462-162), ANALYSIS (68462-163), ANALYSIS (68462-164), ANALYSIS (68462-165), MANUFACTURE (68462-162), MANUFACTURE (68462-163), MANUFACTURE (68462-164), MANUFACTURE (68462-165)
Establishment
Name Address ID/FEI Operations
Glenmark Pharmaceuticals Limited 862603186 ANALYSIS (68462-162), ANALYSIS (68462-163), ANALYSIS (68462-164), ANALYSIS (68462-165), MANUFACTURE (68462-162), MANUFACTURE (68462-163), MANUFACTURE (68462-164), MANUFACTURE (68462-165)

Revised: 08/2023 Glenmark Pharmaceuticals Inc., USA

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