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 ID: 70347-081_eb6e5371-d9fb-4b94-9e1e-224d8cf9f7e4
• NDC: 70347-081
• Product Type: Human Prescription Drug
• Proprietary Name: YOSPRALA
• Generic Name: Aspirin And Omeprazole
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2016-09-14
• Marketing Category: NDA / NDA
• Application Number: NDA205103
• Labeler Name: Aralez Pharmaceuticals Us Inc.
• Substance Name: ASPIRIN; OMEPRAZOLE
• Active Ingredient Strength: 81 mg/1; mg/1
• Pharm Classes: 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 Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 70347-081-90

90 TABLET, FILM COATED in 1 BOTTLE (70347-081-90)

• Marketing Start Date: 2016-09-14
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 70347-081-30 [70347008130]

YOSPRALA TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA205103
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-09-14
• Inactivation Date: 2020-01-31

NDC 70347-081-90 [70347008190]

YOSPRALA TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA205103
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-09-14
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
ASPIRIN	81 mg/1

OpenFDA Data

• SPL SET ID: 73f74f6d-e624-4551-8924-1c747ffb2140
• Manufacturer:
  • Aralez Pharmaceuticals Us Inc.
• UNII:
  • R16CO5Y76E
  • KG60484QX9
• 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"

NDC	Brand Name	Generic Name
64950-424	Yosprala	aspirin and omeprazole
64950-425	Yosprala	aspirin and omeprazole
68071-5102	Yosprala	Yosprala
70347-081	YOSPRALA	Aspirin and Omeprazole
70347-325	YOSPRALA	Aspirin and Omeprazole
71800-012	Yosprala	aspirin and omeprazole
71800-016	Yosprala	aspirin and omeprazole
73568-004	Yosprala	aspirin and omeprazole
73568-005	Yosprala	aspirin and omeprazole
71800-014	aspirin and omeprazole delayed-release tab	aspirin and omeprazole
71800-018	aspirin and omeprazole delayed-release tab	aspirin and omeprazole
73457-415	aspirin and omeprazole delayed-release tab	aspirin and omeprazole
69597-348	ASPIRIN/OMEPRAZOLE	aspirin and omeprazole