NDC 73568-004

Yosprala

Aspirin And Omeprazole

Yosprala is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Pharmaceutika Ltd. The primary component is Aspirin; Omeprazole.

Product ID73568-004_ec415279-46cc-4cac-966e-1da27be91011
NDC73568-004
Product TypeHuman Prescription Drug
Proprietary NameYosprala
Generic NameAspirin And Omeprazole
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2020-01-30
Marketing CategoryNDA / NDA
Application NumberNDA205103
Labeler NamePHARMACEUTIKA LTD
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 Through2021-12-31

Packaging

NDC 73568-004-30

30 TABLET, FILM COATED in 1 BOTTLE (73568-004-30)
Marketing Start Date2020-01-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 73568-004-30 [73568000430]

Yosprala TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA205103
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2020-01-30

Drug Details

Active Ingredients

IngredientStrength
ASPIRIN81 mg/1

Pharmacological Class

  • Platelet 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 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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