Carvedilol

CARVEDILOL- carvedilol tablet, film coated
Cadila Healthcare Limited

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 65841-616-01 in bottle of 100 Tablets

Carvedilol Tablets USP, 3.125 mg

Rx only

100 Tablets

Carvedilol Tablets, 3.125 mg
(click image for full-size original)

NDC 65841-617-01 in bottle of 100 Tablets

Carvedilol Tablets USP, 6.25 mg

Rx only

100 Tablets

Carvedilol Tablets, 6.25 mg
(click image for full-size original)

NDC 65841-618-01 in bottle of 100 Tablets

Carvedilol Tablets USP, 12.5 mg

Rx only

100 Tablets

Carvedilol Tablets, 12.5 mg
(click image for full-size original)

NDC 65841-619-01 in bottle of 100 Tablets

Carvedilol Tablets USP, 25 mg

Rx only

100 Tablets

Carvedilol Tablets,25 mg
(click image for full-size original)
CARVEDILOL
carvedilol tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-616
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
CROSPOVIDONE (12 MPA.S AT 5%)
HYPROMELLOSE, UNSPECIFIED
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL, UNSPECIFIED
POVIDONE K30
SILICON DIOXIDE
TALC
TITANIUM DIOXIDE
Product Characteristics
Color WHITE (WHITE TO OFF-WHITE) Score no score
Shape ROUND (ROUND) Size 4mm
Flavor Imprint Code Z;1
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65841-616-17 28 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:65841-616-01 100 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:65841-616-05 500 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077614 09/05/2007
CARVEDILOL
carvedilol tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-617
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
CROSPOVIDONE (12 MPA.S AT 5%)
HYPROMELLOSE, UNSPECIFIED
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL, UNSPECIFIED
POVIDONE K30
SILICON DIOXIDE
TALC
TITANIUM DIOXIDE
Product Characteristics
Color WHITE (WHITE TO OFF-WHITE) Score no score
Shape ROUND (ROUND) Size 6mm
Flavor Imprint Code ZC40
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65841-617-17 28 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:65841-617-01 100 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:65841-617-05 500 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077614 09/05/2007
CARVEDILOL
carvedilol tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-618
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
CROSPOVIDONE (12 MPA.S AT 5%)
HYPROMELLOSE, UNSPECIFIED
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL, UNSPECIFIED
POVIDONE K30
TALC
TITANIUM DIOXIDE
SILICON DIOXIDE
Product Characteristics
Color WHITE (WHITE TO OFF-WHITE) Score no score
Shape ROUND (ROUND) Size 8mm
Flavor Imprint Code ZC41
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65841-618-17 28 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:65841-618-01 100 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:65841-618-05 500 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077614 09/05/2007
CARVEDILOL
carvedilol tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-619
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
CROSPOVIDONE (12 MPA.S AT 5%)
HYPROMELLOSE, UNSPECIFIED
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL, UNSPECIFIED
POVIDONE K30
TALC
TITANIUM DIOXIDE
SILICON DIOXIDE
Product Characteristics
Color WHITE (WHITE TO OFF-WHITE) Score no score
Shape ROUND (ROUND) Size 10mm
Flavor Imprint Code ZC42
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65841-619-17 28 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:65841-619-01 100 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:65841-619-05 500 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077614 09/05/2007
Labeler — Cadila Healthcare Limited (918596198)
Registrant — Cadila Healthcare Limited (918596198)
Establishment
Name Address ID/FEI Operations
Cadila Healthcare Limited 918596198 ANALYSIS (65841-616), ANALYSIS (65841-617), ANALYSIS (65841-618), ANALYSIS (65841-619), MANUFACTURE (65841-616), MANUFACTURE (65841-617), MANUFACTURE (65841-618), MANUFACTURE (65841-619)
Establishment
Name Address ID/FEI Operations
CADILA HEALTHCARE LIMITED 677605858 ANALYSIS (65841-616), ANALYSIS (65841-617), ANALYSIS (65841-618), ANALYSIS (65841-619), MANUFACTURE (65841-616), MANUFACTURE (65841-617), MANUFACTURE (65841-618), MANUFACTURE (65841-619)

Revised: 08/2020 Cadila Healthcare Limited

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2022. All Rights Reserved.