ONGLYZA (Page 14 of 14)

Package/Label Display Panel

Onglyza®

(saxagliptin) tablets

5 mg

Contains approximately 1080 Tablets

Bottle label
(click image for full-size original)
ONGLYZA saxagliptin tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55154-6931(NDC:0310-6105)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
saxagliptin hydrochloride (saxagliptin anhydrous) saxagliptin anhydrous 5 mg
Inactive Ingredients
Ingredient Name Strength
lactose monohydrate
MICROCRYSTALLINE CELLULOSE
croscarmellose sodium
magnesium stearate
Product Characteristics
Color PINK Score no score
Shape ROUND (biconvex) Size 8mm
Flavor Imprint Code 5;4215
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55154-6931-2 1080 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022350 11/20/2014
Labeler — Cardinal Health 107, LLC (118546603)

Revised: 02/2023 Cardinal Health 107, LLC

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