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Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0085-4324
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name
Basis of Strength
Strength
posaconazole (posaconazole) posaconazole 100 mg
Inactive Ingredients
Ingredient Name
Strength
HYPROMELLOSE ACETATE SUCCINATE 06081224 (3 MM2/S)
CELLULOSE, MICROCRYSTALLINE
HYDROXYPROPYL CELLULOSE (TYPE H)
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
POLYVINYL ALCOHOL
POLYETHYLENE GLYCOL 3350
TITANIUM DIOXIDE
TALC
FERRIC OXIDE YELLOW
Product Characteristics
Color YELLOW Score no score
Shape OVAL (capsule-shaped) Size 17mm
Flavor Imprint Code 100
Contains
Packaging
Item Code
Package Description
Marketing Start Date
Marketing End Date
1
NDC:0085-4324-02 60 in 1 BOTTLE
Marketing Information
Marketing Category
Application Number or Monograph Citation
Marketing Start Date
Marketing End Date
NDA NDA205053 11/25/2013
Labeler - Merck Sharp & Dohme Corp. (001317601)
Establishment
Name
Address
ID/FEI
Business Operations
Merck Sharp & Dohme Corp. 010185964 MANUFACTURE(0085-1328), PACK(0085-1328)
Establishment
Name
Address
ID/FEI
Business Operations
Patheon Inc. 205475333 MANUFACTURE(0085-1328), PACK(0085-1328)
Establishment
Name
Address
ID/FEI
Business Operations
Schering-Plough (Avondale) Company 985098519 API MANUFACTURE(0085-1328, 0085-4324)
Establishment
Name
Address
ID/FEI
Business Operations
N.V. Organon 404467722 MANUFACTURE(0085-4324)
Establishment
Name
Address
ID/FEI
Business Operations
Merck Sharp & Dohme Corp. 101740835 PACK(0085-4324)
Revised: 11/2013
Merck Sharp & Dohme Corp.
