Cholecalciferol

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SOLUTION;INTRAVENOUS - 2 IU/ML;40MG/ML;12MCG/ML;40 IU/ML;1MCG/ML;3MG/ML;120MCG/ML;8MG/ML;1.2MG/ML;0.72MG/ML;1.2MG/ML;660 IU/ML;0.03MG/ML, SOLUTION;INTRAVENOUS - 2 IU/ML;40MG/ML;12MCG/ML;40 IU/ML;1MCG/ML;3MG/ML;120MCG/ML;8MG/ML;1.2MG/ML;0.72MG/ML;1.2MG/ML;660 IU/ML;30MCG/ML, TABLET;ORAL - EQ 70MG BASE;2,800 IU, TABLET;ORAL - EQ 70MG BASE;5,600 IU

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REF. STANDARDS & IMPURITIES

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ANALYTICAL

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USFDA APPLICATION NUMBER - 21762 / DOSAGE - TABLET;ORAL - EQ 70MG BASE;5,600 IU

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALENDRONATE SODIUM(UNII: 2UY4M2U3RA) (ALENDRONIC ACID - UNII:X1J18R4W8P)	ALENDRONIC ACID	70mg \| 70mg
CHOLECALCIFEROL(UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41)	CHOLECALCIFEROL	5600[iU] \| 2800[iU]

Inactive Ingredients

Ingredient Name	Merck Sharp & Dohme Corp.
ANHYDROUS LACTOSE(3SY5LH9PMK)
BUTYLATED HYDROXYTOLUENE(1P9D0Z171K)
CROSCARMELLOSE SODIUM(M28OL1HH48)
GELATIN, UNSPECIFIED(2G86QN327L)
MAGNESIUM STEARATE(70097M6I30)
MEDIUM-CHAIN TRIGLYCERIDES(C9H2L21V7U)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)
SILICON DIOXIDE(ETJ7Z6XBU4)
SODIUM ALUMINOSILICATE(058TS43PSM)
STARCH, CORN(O8232NY3SJ)
SUCROSE(C151H8M554)

Drug Product Composition: Cholecalciferol