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Drug Product Composition: Doxcercalciferol

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USFDA APPLICATION NUMBER - 20862 / DOSAGE - CAPSULE;ORAL - 1MCG

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOXERCALCIFEROL(UNII: 3DIZ9LF5Y9)
(doxercalciferol - UNII:3DIZ9LF5Y9)
DOXERCALCIFEROL1ug | 2.5ug | 0.5ug

Inactive Ingredients

Ingredient Name
American Health Packaging
Avera McKennan Hospital
Genzyme Corporation
Prasco Laboratories
REMEDYREPACK INC.
Winthrop U.S, a business of sanofi-aventis U.S. LLC
ALCOHOL(3K9958V90M)
AMMONIA(5138Q19F1X)     
BUTYL ALCOHOL(8PJ61P6TS3)     
BUTYLATED HYDROXYANISOLE(REK4960K2U)
COCONUT OIL(Q9L0O73W7L)  
D&C YELLOW NO. 10(35SW5USQ3G)     
FD&C RED NO. 40(WZB9127XOA) 
FD&C YELLOW NO. 6(H77VEI93A8)   
FERRIC OXIDE YELLOW(EX438O2MRT) 
FERROSOFERRIC OXIDE(XM0M87F357)     
GELATIN(2G86QN327L)  
GELATIN, UNSPECIFIED(2G86QN327L)    
GLYCERIN(PDC6A3C0OX)
ISOPROPYL ALCOHOL(ND2M416302)     
MEDIUM-CHAIN TRIGLYCERIDES(C9H2L21V7U)    
PROPYLENE GLYCOL(6DC9Q167V3)     
SHELLAC(46N107B71O)     
TITANIUM DIOXIDE(15FIX9V2JP)
WATER(059QF0KO0R)