Candesartan Cilexetil and Hydrochlorothiazide (Page 6 of 6)

HOW SUPPLIED

Candesartan Cilexetil and Hydrochlorothiazide Tablets, USP are available containing 16 mg or 32 mg of candesartan cilexetil, USP and 12.5 mg or 25 mg of hydrochlorothiazide, USP providing for the following available combinations: 16 mg/12.5 mg, 32 mg/12.5 mg or 32 mg/25 mg.

The 16 mg/12.5 mg tablets are peach, mottled, round, scored tablets debossed with M on the left side of the score and X on the right side of the score on one side of the tablet and C1 on the other side of the tablet. They are available as follows:

NDC 0378-3001-77
bottles of 90 tablets

NDC 0378-3001-05
bottles of 500 tablets

The 32 mg/12.5 mg tablets are yellow, mottled, round, scored tablets debossed with M on the left side of the score and X on the right side of the score on one side of the tablet and C2 on the other side of the tablet. They are available as follows:

NDC 0378-3002-77
bottles of 90 tablets

NDC 0378-3002-05
bottles of 500 tablets

The 32 mg/25 mg tablets are peach, mottled, round, scored tablets debossed with M on the left of the score and X on the right of the score on one side of the tablet and C3 on the other side of the tablet. They are available as follows:

NDC 0378-3003-77
bottles of 90 tablets

NDC 0378-3003-05
bottles of 500 tablets

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

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

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

Manufactured by:
Mylan Laboratories Limited
Hyderabad — 500 096, India

75076992

Revised: 8/2020
MX:CNDHTZ:R10

PRINCIPAL DISPLAY PANEL — 16 mg/12.5 mg

NDC 0378-3001-77

Candesartan
Cilexetil and
Hydrochlorothiazide
Tablets, USP
16 mg/
12.5 mg

Rx only 90 Tablets

Each tablet contains:
Candesartan cilexetil, USP 16 mg
Hydrochlorothiazide, USP 12.5 mg

Usual Adult 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.]

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

Made in India

Mylan.com

RMX3001MM4

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

Keep container tightly closed.

Code No.: MH/DRUGS/25/NKD/89

Candesartan and HCTZ Tablets 16 mg/12.5  mg Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 32 mg/12.5 mg

NDC 0378-3002-77

Candesartan
Cilexetil and
Hydrochlorothiazide
Tablets, USP
32 mg/
12.5 mg

Rx only 90 Tablets

Each tablet contains:
Candesartan cilexetil, USP 32 mg
Hydrochlorothiazide, USP 12.5 mg

Usual Adult 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.]

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

Made in India

Mylan.com

RMX3002MM4

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

Keep container tightly closed.

Code No.: MH/DRUGS/25/NKD/89

Candesartan and HCTZ Tablets 32 mg/12.5 mg Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 32 mg/25 mg

NDC 0378-3003-77

Candesartan
Cilexetil and
Hydrochlorothiazide
Tablets, USP
32 mg/
25 mg

Rx only 90 Tablets

Each tablet contains:
Candesartan cilexetil, USP 32 mg
Hydrochlorothiazide, USP 25 mg

Usual Adult 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.]

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

Made in India

Mylan.com

RMX3003MM4

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

Keep container tightly closed.

Code No.: MH/DRUGS/25/NKD/89

Candesartan and HCTZ Tablets 32 mg/25 mg Bottle Label
(click image for full-size original)
CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE candesartan cilexetil and hydrochlorothiazide tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0378-3001
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CANDESARTAN CILEXETIL (CANDESARTAN) CANDESARTAN CILEXETIL 16 mg
HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE 12.5 mg
Inactive Ingredients
Ingredient Name Strength
CARBOXYMETHYLCELLULOSE CALCIUM
STARCH, CORN
GLYCERYL MONOSTEARATE
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
Product Characteristics
Color ORANGE (peach mottled) Score 2 pieces
Shape ROUND Size 7mm
Flavor Imprint Code M;X;C1
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0378-3001-77 90 TABLET in 1 BOTTLE, PLASTIC None
2 NDC:0378-3001-05 500 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090704 12/04/2012
CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE candesartan cilexetil and hydrochlorothiazide tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0378-3002
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CANDESARTAN CILEXETIL (CANDESARTAN) CANDESARTAN CILEXETIL 32 mg
HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE 12.5 mg
Inactive Ingredients
Ingredient Name Strength
CARBOXYMETHYLCELLULOSE CALCIUM
STARCH, CORN
GLYCERYL MONOSTEARATE
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
FERRIC OXIDE YELLOW
Product Characteristics
Color YELLOW (yellow mottled) Score 2 pieces
Shape ROUND Size 9mm
Flavor Imprint Code M;X;C2
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0378-3002-77 90 TABLET in 1 BOTTLE, PLASTIC None
2 NDC:0378-3002-05 500 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090704 12/04/2012
CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE candesartan cilexetil and hydrochlorothiazide tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0378-3003
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CANDESARTAN CILEXETIL (CANDESARTAN) CANDESARTAN CILEXETIL 32 mg
HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE 25 mg
Inactive Ingredients
Ingredient Name Strength
CARBOXYMETHYLCELLULOSE CALCIUM
STARCH, CORN
GLYCERYL MONOSTEARATE
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
Product Characteristics
Color ORANGE (peach mottled) Score 2 pieces
Shape ROUND Size 10mm
Flavor Imprint Code M;X;C3
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0378-3003-77 90 TABLET in 1 BOTTLE, PLASTIC None
2 NDC:0378-3003-05 500 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090704 12/04/2012
Labeler — Mylan Pharmaceuticals Inc. (059295980)

Revised: 08/2020 Mylan Pharmaceuticals Inc.

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