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CADUET® (amlodipine besilate, atorvastatin calcium) How Supplied/Storage and Handling

16 HOW SUPPLIED/STORAGE AND HANDLING

CADUET® tablets contain amlodipine besylate and atorvastatin calcium equivalent to amlodipine and atorvastatin in the dose strengths described below.

CADUET tablets are differentiated by tablet color/size and are engraved with a unique number on one side. Combinations of atorvastatin with 2.5 mg amlodipine are round and film-coated white, combinations of atorvastatin with 5 mg amlodipine are oval and film-coated white, and combinations of atorvastatin with 10 mg amlodipine are oval and are film-coated blue. CADUET tablets are supplied for oral administration in the following strengths and package configurations:

Table 14. CADUET Packaging Configurations
CADUET
Package Configuration Tablet Strength mg (amlodipine / atorvastatin) NDC # Engraving
Side 1 / Side 2
Tablet Color Tablet Shape
Bottle of 30 2.5/10 0069-2960-30 CDT 251 / Blank White Round
Bottle of 30 2.5/20 0069-2970-30 CDT 252 / Blank White Round
Bottle of 30 2.5/40 0069-2980-30 CDT 254 / Blank White Round
Bottle of 30 5/10 0069-2150-30 CDT 051 / Pfizer White Oval
Bottle of 30 5/20 0069-2170-30 CDT 052 / Pfizer White Oval
Bottle of 30 5/40 0069-2190-30 CDT 054 / Pfizer White Oval
Bottle of 30 5/80 0069-2260-30 CDT 058 / Pfizer White Oval
Bottle of 30 10/10 0069-2160-30 CDT 101 / Pfizer Blue Oval
Bottle of 30 10/20 0069-2180-30 CDT 102 / Pfizer Blue Oval
Bottle of 30 10/40 0069-2250-30 CDT 104 / Pfizer Blue Oval
Bottle of 30 10/80 0069-2270-30 CDT 108 / Pfizer Blue Oval

Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature].

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