DESLORATADINE- desloratadine tablet, orally disintegrating 
Anesta Corporation

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Desloratadine Orally disintegrating tablet

Package/Label Display Panel

Desloratadine Orally Disintegrating Tablets 2.5 mg Container Label

Package/Label Display Panel

Desloratadine Orally Disintegrating Tablets 5 mg Container Label
DESLORATADINE 
desloratadine tablet, orally disintegrating
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65729-384
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DESLORATADINE (UNII: FVF865388R) (DESLORATADINE - UNII:FVF865388R) DESLORATADINE2.5 mg
Inactive Ingredients
Ingredient NameStrength
MANNITOL (UNII: 3OWL53L36A)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
STARCH, CORN (UNII: O8232NY3SJ)  
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER (UNII: 905HNO1SIH)  
CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)  
ASPARTAME (UNII: Z0H242BBR1)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Product Characteristics
ColorRED (light red) Scoreno score
ShapeROUNDSize6mm
FlavorTUTTI FRUTTIImprint Code K
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65729-384-026 in 1 BLISTER PACK; Type 0: Not a Combination Product05/01/201501/31/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
EXPORT ONLY05/01/201501/31/2020
DESLORATADINE 
desloratadine tablet, orally disintegrating
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65729-408
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DESLORATADINE (UNII: FVF865388R) (DESLORATADINE - UNII:FVF865388R) DESLORATADINE5 mg
Inactive Ingredients
Ingredient NameStrength
MANNITOL (UNII: 3OWL53L36A)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
STARCH, CORN (UNII: O8232NY3SJ)  
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER (UNII: 905HNO1SIH)  
CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)  
ASPARTAME (UNII: Z0H242BBR1)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Product Characteristics
ColorRED (light red) Scoreno score
ShapeROUNDSize8mm
FlavorTUTTI FRUTTIImprint Code A
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65729-408-015 in 1 BLISTER PACK; Type 0: Not a Combination Product05/01/2015
2NDC:65729-408-026 in 1 BLISTER PACK; Type 0: Not a Combination Product05/01/201501/31/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
EXPORT ONLY05/01/201501/31/2020
Labeler - Anesta Corporation (177319472)

Revised: 5/2016
Document Id: 3702bd7b-430c-46ca-8222-9e70dcb5417d
Set id: 84b20dcb-e15b-44a2-b692-1eea5adb996e
Version: 3
Effective Time: 20160527
 
Anesta Corporation