NDC Code(s) : 0378-3631-01, 0378-3631-05, 0378-3632-01, 0378-3632-05, 0378-3633-01, 0378-3633-05, 0378-3634-01, 0378-3634-05
Packager : Mylan Pharmaceuticals Inc.

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:0378-3631
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, UNSPECIFIED(UNII: 2S7830E561)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
POLYDEXTROSE(UNII: VH2XOU12IE)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
STARCH, CORN(UNII: O8232NY3SJ)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
Product Characteristics
Color BLUE Score no score
Shape ROUND Size 6 mm
Flavor Imprint Code M;C31
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0378-3631-01100 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product09/05/2007
2NDC:0378-3631-05500 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product09/05/2007
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077316 09/05/2007 03/31/2024
Carvedilolcarvedilol TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0378-3632
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, UNSPECIFIED(UNII: 2S7830E561)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
POLYDEXTROSE(UNII: VH2XOU12IE)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
STARCH, CORN(UNII: O8232NY3SJ)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 6 mm
Flavor Imprint Code M;C32
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0378-3632-01100 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product09/05/2007
2NDC:0378-3632-05500 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product09/05/2007
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077316 09/05/2007 02/28/2025
Carvedilolcarvedilol TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0378-3633
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, UNSPECIFIED(UNII: 2S7830E561)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
POLYDEXTROSE(UNII: VH2XOU12IE)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
STARCH, CORN(UNII: O8232NY3SJ)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 8 mm
Flavor Imprint Code M;C33
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0378-3633-01100 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product09/05/2007
2NDC:0378-3633-05500 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product09/05/2007
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077316 09/05/2007 03/31/2025
Carvedilolcarvedilol TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0378-3634
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, UNSPECIFIED(UNII: 2S7830E561)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
POLYDEXTROSE(UNII: VH2XOU12IE)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
STARCH, CORN(UNII: O8232NY3SJ)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 10 mm
Flavor Imprint Code M;C34
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0378-3634-01100 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product09/05/2007
2NDC:0378-3634-05500 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product09/05/2007
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077316 09/05/2007 03/31/2025

LABELER - Mylan Pharmaceuticals Inc.(059295980)

PRINCIPAL DISPLAY PANEL

NDC 0378-3631-01

Carvedilol
Tablets, USP
3.125 mg

PHARMACIST: Dispense the accompanying
Patient Information Leaflet to each patient.

Rx only 100 Tablets

Each film-coated tablet contains:
Carvedilol, USP 3.125 mg

Usual Dosage: See accompanying
prescribing information.

Keep this and all medication out of the
reach of children.

Store at 20° to 25°C (68° to 77°F).
[See USP Controlled Room
Temperature.]

Protect from moisture.

Manufactured for:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Made in India

Mylan.com

Dispense in a tight, light-resistant
container as defined in the USP
using a child-resistant closure.

Keep container tightly closed.

Code No.: MP/DRUGS/25/1/2014

RMXI3631A2

Carvedilol Tablets, USP 3.125 mg Bottle Label

PRINCIPAL DISPLAY PANEL

NDC 0378-3632-01

Carvedilol
Tablets, USP
6.25 mg

PHARMACIST: Dispense the accompanying
Patient Information Leaflet to each patient.

Rx only 100 Tablets

Each film-coated tablet contains:
Carvedilol, USP 6.25 mg

Usual Dosage: See accompanying
prescribing information.

Keep this and all medication out of the
reach of children.

Store at 20° to 25°C (68° to 77°F).
[See USP Controlled Room
Temperature.]

Protect from moisture.

Manufactured for:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Made in India

Mylan.com

Dispense in a tight, light-resistant
container as defined in the USP
using a child-resistant closure.

Keep container tightly closed.

Code No.: MP/DRUGS/25/1/2014

RMXI3632A2

Carvedilol Tablets, USP 6.25 mg Bottle Label

PRINCIPAL DISPLAY PANEL

NDC 0378-3633-01

Carvedilol
Tablets, USP
12.5 mg

PHARMACIST: Dispense the accompanying
Patient Information Leaflet to each patient.

Rx only 100 Tablets

Each film-coated tablet contains:
Carvedilol, USP 12.5 mg

Usual Dosage: See accompanying
prescribing information.

Keep this and all medication out of the
reach of children.

Store at 20° to 25°C (68° to 77°F).
[See USP Controlled Room
Temperature.]

Protect from moisture.

Manufactured for:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Made in India

Mylan.com

Dispense in a tight, light-resistant
container as defined in the USP
using a child-resistant closure.

Keep container tightly closed.

Code No.: MP/DRUGS/25/1/2014

RMXI3633A2

Carvedilol Tablets, USP 12.5 mg Bottle Label

PRINCIPAL DISPLAY PANEL

NDC 0378-3634-01

Carvedilol
Tablets, USP
25 mg

PHARMACIST: Dispense the accompanying
Patient Information Leaflet to each patient.

Rx only 100 Tablets

Each film-coated tablet contains:
Carvedilol, USP 25 mg

Usual Dosage: See accompanying
prescribing information.

Keep this and all medication out of the
reach of children.

Store at 20° to 25°C (68° to 77°F).
[See USP Controlled Room
Temperature.]

Protect from moisture.

Manufactured for:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Made in India

Mylan.com

Dispense in a tight, light-resistant
container as defined in the USP
using a child-resistant closure.

Keep container tightly closed.

Code No.: MP/DRUGS/25/1/2014

RMXI3634A2

Carvedilol Tablets, USP 25 mg Bottle Label