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 ID: 73568-004_ec415279-46cc-4cac-966e-1da27be91011
• NDC: 73568-004
• 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: 2020-01-30
• Marketing Category: NDA / NDA
• Application Number: NDA205103
• Labeler Name: PHARMACEUTIKA LTD
• 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: 2021-12-31

Packaging

NDC 73568-004-30

30 TABLET, FILM COATED in 1 BOTTLE (73568-004-30)

• Marketing Start Date: 2020-01-30
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 73568-004-30 [73568000430]

Yosprala TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA205103
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2020-01-30

Drug Details

Active Ingredients

Ingredient	Strength
ASPIRIN	81 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"

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