VYTORIN (Page 10 of 10)

PRINCIPAL DISPLAY PANEL — Bottle Label 10/20

VYTORIN® 10/20
(ezetimibe/simvastatin)

Each tablet contains 10 mg ezetimibe and 20 mg simvastatin.

Store at 20-25°C (68-77°F). [See USP Controlled Room Temperature.]
Keep container tightly closed.

Rx only

USUAL ADULT DOSAGE: See accompanying circular.

30 Tablets

NDC 21695-325-30

Dist. by:
MERCK/Schering-Plough Pharmaceuticals
North Wales, PA 19454, U. S. A.

Jointly manuf. by:
Merck Sharp & Dohme (Italia) S.p.A.
Via Emilia, 21
27100 — Pavia, Italy
and
MSD Technology Singapore Pte. Ltd.
Singapore 637766

Product of Singapore.

973240230 | No. 3874

Repackaged by:

Rebel Distributors Corp

Thousand Oaks, CA 91320

Vytorin 10/20mg
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — Bottle Label 10/40

VYTORIN® 10/40
(ezetimibe/simvastatin)

Each tablet contains 10 mg ezetimibe and 40 mg simvastatin.

Store at 20-25°C (68-77°F). [See USP Controlled Room Temperature.]
Keep container tightly closed.

30 Tablets

NDC 21695-339-30

Rx only

USUAL ADULT DOSAGE: See accompanying circular.

Dist. by:
MERCK/Schering-Plough Pharmaceuticals
North Wales, PA 19454, U. S. A.

Manuf. by:
Merck Sharp & Dohme (Italia) S.p.A.
Via Emilia, 21
27100 — Pavia, Italy

Formulated in Italy.

986190030 | No. 3875

Repackaged by:

Rebel Distributors Corp

Thousand Oaks, CA 91320

Vytorin 10/40mg
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — Bottle Label 10/80

VYTORIN® 10/80
(ezetimibe/simvastatin)

Each tablet contains 10 mg ezetimibe and 80 mg simvastatin.

Store at 20-25°C (68-77°F). [See USP Controlled Room Temperature.]
Keep container tightly closed.

30 Tablets

NDC 21695-827-30

Rx only

USUAL ADULT DOSAGE: See accompanying circular.

Dist. by:
MERCK/Schering-Plough Pharmaceuticals
North Wales, PA 19454, U. S. A.

Manuf. by:
MSD Technology Singapore Pte. Ltd.
Singapore 637766

Product of Singapore.

973260130 | No. 3876

Repackaged by:

Rebel Distributors Corp

Thousand Oaks, CA 91320

Vytorin 10/80mg
(click image for full-size original)

VYTORIN ezetimibe and simvastatin tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:21695-325(NDC:66582-312)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ezetimibe (ezetimibe) ezetimibe 10 mg
simvastatin (simvastatin) simvastatin 20 mg
Inactive Ingredients
Ingredient Name Strength
butylated hydroxyanisole
citric acid monohydrate
croscarmellose sodium
HYPROMELLOSES
lactose monohydrate
magnesium stearate
propyl gallate
CELLULOSE, MICROCRYSTALLINE
Product Characteristics
Color white (white to off-white) Score no score
Shape OVAL (capsule-shaped) Size 11mm
Flavor Imprint Code 312
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:21695-325-30 30 TABLET (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021687 07/23/2004
VYTORIN ezetimibe and simvastatin tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:21695-339(NDC:66582-313)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ezetimibe (ezetimibe) ezetimibe 10 mg
simvastatin (simvastatin) simvastatin 40 mg
Inactive Ingredients
Ingredient Name Strength
butylated hydroxyanisole
citric acid monohydrate
croscarmellose sodium
HYPROMELLOSES
lactose monohydrate
magnesium stearate
propyl gallate
CELLULOSE, MICROCRYSTALLINE
Product Characteristics
Color white (white to off-white) Score no score
Shape OVAL (capsule-shaped) Size 14mm
Flavor Imprint Code 313
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:21695-339-30 30 TABLET (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021687 07/23/2004
VYTORIN ezetimibe and simvastatin tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:21695-827(NDC:66582-315)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ezetimibe (ezetimibe) ezetimibe 10 mg
simvastatin (simvastatin) simvastatin 80 mg
Inactive Ingredients
Ingredient Name Strength
butylated hydroxyanisole
citric acid monohydrate
croscarmellose sodium
HYPROMELLOSES
lactose monohydrate
magnesium stearate
propyl gallate
CELLULOSE, MICROCRYSTALLINE
Product Characteristics
Color white (white to off-white) Score no score
Shape OVAL (capsule-shaped) Size 17mm
Flavor Imprint Code 315
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:21695-827-30 30 TABLET (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021687 07/23/2004
Labeler — Rebel Distributors Corp (118802834)
Establishment
Name Address ID/FEI Operations
Rebel Distributors Corp 118802834 RELABEL, REPACK

Revised: 12/2010 Rebel Distributors Corp

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