NDC 0310-6100

ONGLYZA

Saxagliptin

ONGLYZA is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Astrazeneca Pharmaceuticals Lp. The primary component is Saxagliptin Hydrochloride.

Product ID0310-6100_2548e014-3ba3-46d0-9eaa-85f8c9613b35
NDC0310-6100
Product TypeHuman Prescription Drug
Proprietary NameONGLYZA
Generic NameSaxagliptin
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2014-11-20
Marketing CategoryNDA / NDA
Application NumberNDA022350
Labeler NameAstraZeneca Pharmaceuticals LP
Substance NameSAXAGLIPTIN HYDROCHLORIDE
Active Ingredient Strength3 mg/1
Pharm ClassesDipeptidyl Peptidase 4 Inhibitor [EPC],Dipeptidyl Peptidase 4 Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0310-6100-30

30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0310-6100-30)
Marketing Start Date2014-11-21
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0310-6100-90 [00310610090]

ONGLYZA TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA022350
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-01-06

NDC 0310-6100-95 [00310610095]

ONGLYZA TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA022350
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-08-11

NDC 0310-6100-30 [00310610030]

ONGLYZA TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA022350
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-11-21

Drug Details

Active Ingredients

IngredientStrength
SAXAGLIPTIN HYDROCHLORIDE2.5 mg/1

OpenFDA Data

SPL SET ID:c5116390-e0fe-4969-94cb-e9de5165fbab
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 858044
  • 858036
  • 858042
  • 858040
    • UPC Code
  • 0303106105304
  • 0303106100309

    • Pharmacological Class

    • Dipeptidyl Peptidase 4 Inhibitor [EPC]
    • Dipeptidyl Peptidase 4 Inhibitors [MoA]

    NDC Crossover Matching brand name "ONGLYZA" or generic name "Saxagliptin"

    NDCBrand NameGeneric Name
    0310-6100ONGLYZASAXAGLIPTIN
    0310-6105ONGLYZASAXAGLIPTIN
    55154-6931ONGLYZASAXAGLIPTIN

    Trademark Results [ONGLYZA]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ONGLYZA
    ONGLYZA
    85504669 not registered Dead/Abandoned
    Bristol-Myers Squibb Company
    2011-12-28
    ONGLYZA
    ONGLYZA
    85162195 3970694 Dead/Cancelled
    ASTRAZENECA AB
    2010-10-27
    ONGLYZA
    ONGLYZA
    78791308 3723838 Live/Registered
    ASTRAZENECA AB
    2006-01-13
    ONGLYZA
    ONGLYZA
    77871907 not registered Dead/Abandoned
    Bristol-Myers Squibb Company
    2009-11-13
    ONGLYZA
    ONGLYZA
    77798656 not registered Dead/Abandoned
    ASTRAZENECA AB
    2009-08-06
    ONGLYZA
    ONGLYZA
    77769979 not registered Dead/Abandoned
    Bristol-Myers Squibb Company
    2009-06-29
    ONGLYZA
    ONGLYZA
    77769972 not registered Dead/Abandoned
    Bristol-Myers Squibb Company
    2009-06-29
    ONGLYZA
    ONGLYZA
    77411067 not registered Dead/Abandoned
    Bristol-Myers Squibb Company
    2008-03-03
    ONGLYZA
    ONGLYZA
    77394393 not registered Dead/Abandoned
    Bristol-Myers Squibb Company
    2008-02-12
    ONGLYZA
    ONGLYZA
    77394390 not registered Dead/Abandoned
    Bristol-Myers Squibb Company
    2008-02-12
    ONGLYZA
    ONGLYZA
    77342421 not registered Dead/Abandoned
    Bristol-Myers Squibb Company
    2007-12-03
    ONGLYZA
    ONGLYZA
    77342416 not registered Dead/Abandoned
    Bristol-Myers Squibb Company
    2007-12-03
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.