kaging
Item Code Package Description
1 NDC:49884-325-62 30 FILM, SOLUBLE (POUCH) in 1 CARTON
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022524 07/05/2010 07/31/2012
Zuplenz
ondansetron film, soluble
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49884-324
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ONDANSETRON (ONDANSETRON) ONDANSETRON 4 mg
Inactive Ingredients
Ingredient Name Strength
BUTYLATED HYDROXYTOLUENE
CALCIUM CARBONATE
COLLOIDAL SILICON DIOXIDE
SODIUM BICARBONATE
SUCRALOSE
TITANIUM DIOXIDE
XANTHAN GUM
Product Characteristics
Color black Score
Shape RECTANGLE Size 16mm
Flavor PEPPERMINT Imprint Code 4;mg
Contains
Packaging
Item Code Package Description
1 NDC:49884-324-62 30 FILM, SOLUBLE (POUCH) in 1 CARTON
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022524 07/05/2010
Labeler - Par Pharmaceutical, Inc. (092733690)
Registrant - Par Pharmaceutical, Inc (092733690)
Establishment
Name Address ID/FEI Operations
MonoSol Rx 785935235 manufacture(49884-325, 49884-324)
Establishment
Name Address ID/FEI Operations
Lancaster Laboratories 069777290 analysis(49884-325, 49884-324)
Revised: 10/2012
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