ONGLYZA (Page 14 of 14)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 5 mg

30 Tablets NDC 0310-6105-30
onglyza®
(saxagliptin) tablets
5 mg
DISPENSE WITH MEDICATION GUIDE
Rx only AstraZeneca

Onglyza 5 mg Bottle Label
(click image for full-size original)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 2.5 mg

30 Tablets NDC 0310-6100-30
onglyza®
(saxagliptin) tablets
2.5 mg
DISPENSE WITH MEDICATION GUIDE
Rx onlyAstraZeneca

Onglyza 2.5 Bottle Label
(click image for full-size original)
ONGLYZA saxagliptin tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) 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:0310-6105-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
2 NDC:0310-6105-90 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
3 NDC:0310-6105-50 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
4 NDC:0310-6105-95 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK
4 7 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (0310-6105-95)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022350 11/20/2014
ONGLYZA saxagliptin tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0310-6100
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
saxagliptin hydrochloride (saxagliptin anhydrous) saxagliptin anhydrous 2.5 mg
Inactive Ingredients
Ingredient Name Strength
lactose monohydrate
MICROCRYSTALLINE CELLULOSE
croscarmellose sodium
magnesium stearate
Product Characteristics
Color YELLOW (pale yellow to light yellow) Score no score
Shape ROUND (biconvex) Size 8mm
Flavor Imprint Code 2;5;4214
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0310-6100-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
2 NDC:0310-6100-90 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
3 NDC:0310-6100-95 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK
3 7 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (0310-6100-95)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022350 11/20/2014
Labeler — AstraZeneca Pharmaceuticals LP (054743190)
Registrant — AstraZeneca PLC (230790719)

Revised: 10/2019 AstraZeneca Pharmaceuticals LP

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