NDC 69597-348

ASPIRIN/OMEPRAZOLE

Aspirin And Omeprazole

ASPIRIN/OMEPRAZOLE is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Basiem. The primary component is Aspirin; Omeprazole.

• Product ID: 69597-348_bef20e05-a18c-4d1f-96ce-e13072ffeebd
• NDC: 69597-348
• Product Type: Human Prescription Drug
• Proprietary Name: ASPIRIN/OMEPRAZOLE
• Generic Name: Aspirin And Omeprazole
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2019-04-10
• Marketing Category: NDA / NDA
• Application Number: NDA205103
• Labeler Name: Basiem
• Substance Name: ASPIRIN; OMEPRAZOLE
• Active Ingredient Strength: 81 mg/1; mg/1
• Pharm Classes: 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]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 69597-348-15

15 TABLET, FILM COATED in 1 BOTTLE (69597-348-15)

• Marketing Start Date: 2019-04-10
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 69597-348-15 [69597034815]

ASPIRIN/OMEPRAZOLE TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA205103
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2019-04-10
• Marketing End Date: 2019-04-28

Drug Details

Active Ingredients

Ingredient	Strength
ASPIRIN	81 mg/1

OpenFDA Data

• SPL SET ID: 603511cf-f9f6-4a7f-8885-34c5978b9677
• Manufacturer:
  • Basiem
• UNII:
  • R16CO5Y76E
  • KG60484QX9
• 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:
  • 0369597348156
• 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]

NDC Crossover Matching brand name "ASPIRIN/OMEPRAZOLE" or generic name "Aspirin And Omeprazole"

NDC	Brand Name	Generic Name
69597-348	ASPIRIN/OMEPRAZOLE	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
64950-424	Yosprala	aspirin and omeprazole
64950-425	Yosprala	aspirin and omeprazole
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