NDC 70347-081

YOSPRALA

Aspirin And Omeprazole

YOSPRALA is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Aralez Pharmaceuticals Us Inc.. The primary component is Aspirin; Omeprazole.

Product ID70347-081_eb6e5371-d9fb-4b94-9e1e-224d8cf9f7e4
NDC70347-081
Product TypeHuman Prescription Drug
Proprietary NameYOSPRALA
Generic NameAspirin And Omeprazole
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2016-09-14
Marketing CategoryNDA / NDA
Application NumberNDA205103
Labeler NameAralez Pharmaceuticals Us Inc.
Substance NameASPIRIN; OMEPRAZOLE
Active Ingredient Strength81 mg/1; mg/1
Pharm ClassesPlatelet Aggregation Inhibitor [EPC],Decreased Platelet Aggregation [PE],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC],Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 70347-081-90

90 TABLET, FILM COATED in 1 BOTTLE (70347-081-90)
Marketing Start Date2016-09-14
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70347-081-30 [70347008130]

YOSPRALA TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA205103
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-09-14
Inactivation Date2020-01-31

NDC 70347-081-90 [70347008190]

YOSPRALA TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA205103
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-09-14
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
ASPIRIN81 mg/1

OpenFDA Data

SPL SET ID:73f74f6d-e624-4551-8924-1c747ffb2140
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1811632
  • 1811631
  • 1811916
  • 1811918
  • Pharm Class PE
  • Decreased Prostaglandin Production [PE]
  • Decreased Platelet Aggregation [PE]
  • PHarm Class EPC
  • Nonsteroidal Anti-inflammatory Drug [EPC]
  • Platelet Aggregation Inhibitor [EPC]
  • UPC Code
  • 0370347325907
  • 0370347081902
  • 0370347325303
  • NUI Code
  • N0000008832
  • N0000008836
  • N0000175721
  • N0000000160
  • N0000175578
  • N0000175722
  • Pharmacological Class

    • Cyclooxygenase Inhibitors [MoA]
    • Decreased Prostaglandin Production [PE]
    • Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient]
    • Nonsteroidal Anti-inflammatory Drug [EPC]
    • Platelet Aggregation Inhibitor [EPC]
    • Decreased Platelet Aggregation [PE]
    • Proton Pump Inhibitor [EPC]
    • Proton Pump Inhibitors [MoA]
    • Cytochrome P450 2C19 Inhibitors [MoA]
    • Anti-Inflammatory Agents
    • Non-Steroidal [CS]

    NDC Crossover Matching brand name "YOSPRALA" or generic name "Aspirin And Omeprazole"

    NDCBrand NameGeneric Name
    64950-424Yospralaaspirin and omeprazole
    64950-425Yospralaaspirin and omeprazole
    68071-5102YospralaYosprala
    70347-081YOSPRALAAspirin and Omeprazole
    70347-325YOSPRALAAspirin and Omeprazole
    71800-012Yospralaaspirin and omeprazole
    71800-016Yospralaaspirin and omeprazole
    73568-004Yospralaaspirin and omeprazole
    73568-005Yospralaaspirin and omeprazole
    71800-014aspirin and omeprazole delayed-release tabaspirin and omeprazole
    71800-018aspirin and omeprazole delayed-release tabaspirin and omeprazole
    73457-415aspirin and omeprazole delayed-release tabaspirin and omeprazole
    69597-348ASPIRIN/OMEPRAZOLEaspirin and omeprazole

    Trademark Results [YOSPRALA]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    YOSPRALA
    YOSPRALA
    87107388 not registered Dead/Abandoned
    POZEN Inc
    2016-07-18
    YOSPRALA
    YOSPRALA
    86011803 5124592 Live/Registered
    POZEN Inc.
    2013-07-16

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