Carvedilol (Page 7 of 7)

Package/Label Display Panel- 3.125mg 30s

NDC 10544-184-30

Carvedilol Tablets, USP

3.125 mg

Pharmacist: Dispense the accompanying

Patient Information Leaflet to each patient.

Rx only 30 Tablets

Blenheim Pharmacal, Inc.

Label Graphic-3.125mg 30s
(click image for full-size original)

Package/Label Display Panel 6.25 mg 30s

NDC 10544-187-30

Carvedilol Tablets, USP

6.25 mg

Pharmacist: Dispense the accompanying

Patient Information Leaflet to each patient.

Rx only 30 Tablets

Blenheim Pharmacal, Inc.

Label Graphic-6.25mg 30s
(click image for full-size original)

Package/Label Display Panel

NDC 10544-190-30

Carvedilol Tablets, USP

12.5 mg

Pharmacist: Dispense the accompanying

Patient Information Leaflet to each patient.

Rx only 30 Tablets

Blenheim Pharmacal, Inc.

Label Graphic-12.5 mg 30s
(click image for full-size original)

Package/Label Display Panel 25mg 30s

NDC 10544-191-30

Carvedilol Tablets, USP

25 mg

Pharmacist: Dispense the accompanying

Patient Information Leaflet to each patient.

Rx only 30 Tablets

Blenheim Pharmacal, Inc.

Label Graphic- 25mg 30s
(click image for full-size original)
CARVEDILOL carvedilol tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10544-184(NDC:65862-142)
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
LACTOSE MONOHYDRATE
SILICON DIOXIDE
CROSPOVIDONE
POVIDONE K30
SUCROSE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL 400
POLYSORBATE 80
TITANIUM DIOXIDE
HYPROMELLOSE 2910 (5 MPA.S)
Product Characteristics
Color WHITE (White to Off-white) Score no score
Shape OVAL Size 6mm
Flavor Imprint Code E;01
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:10544-184-30 30 TABLET, FILM COATED in 1 BOTTLE None
Image of Product
(click image for full-size original)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078332 11/15/2013
CARVEDILOL carvedilol tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10544-187(NDC:65862-143)
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
LACTOSE MONOHYDRATE
SILICON DIOXIDE
CROSPOVIDONE
POVIDONE K30
SUCROSE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL 400
POLYSORBATE 80
TITANIUM DIOXIDE
HYPROMELLOSE 2910 (5 MPA.S)
Product Characteristics
Color WHITE (White to Off-white) Score no score
Shape OVAL Size 8mm
Flavor Imprint Code E;02
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:10544-187-30 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:10544-187-90 90 TABLET, FILM COATED in 1 BOTTLE None
Image of Product
(click image for full-size original)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078332 11/15/2013
CARVEDILOL carvedilol tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10544-190(NDC:65862-144)
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
LACTOSE MONOHYDRATE
SILICON DIOXIDE
CROSPOVIDONE
POVIDONE K30
SUCROSE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL 400
POLYSORBATE 80
TITANIUM DIOXIDE
HYPROMELLOSE 2910 (5 MPA.S)
Product Characteristics
Color WHITE (White to Off-white) Score no score
Shape OVAL Size 11mm
Flavor Imprint Code E;03
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:10544-190-30 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:10544-190-90 90 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:10544-190-81 180 TABLET, FILM COATED in 1 BOTTLE None
Image of Product
(click image for full-size original)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078332 11/15/2013
CARVEDILOL carvedilol tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10544-191(NDC:65862-145)
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
LACTOSE MONOHYDRATE
SILICON DIOXIDE
CROSPOVIDONE
POVIDONE K30
SUCROSE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL 400
POLYSORBATE 80
TITANIUM DIOXIDE
HYPROMELLOSE 2910 (5 MPA.S)
Product Characteristics
Color WHITE (White to Off-white) Score no score
Shape OVAL Size 13mm
Flavor Imprint Code E;04
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:10544-191-30 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:10544-191-90 90 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078332 11/15/2013
Labeler — Blenheim Pharmacal, Inc. (171434587)
Registrant — Blenheim Pharmacal, Inc. (171434587)
Establishment
Name Address ID/FEI Operations
Blenheim Pharmacal, Inc. 171434587 RELABEL (10544-184), RELABEL (10544-187), RELABEL (10544-190), RELABEL (10544-191), REPACK (10544-184), REPACK (10544-187), REPACK (10544-190), REPACK (10544-191)

Revised: 02/2015 Blenheim Pharmacal, Inc.

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