ASPIRIN/OMEPRAZOLE

Product NDC

69597-348

11-digit product format

695970348

Labeler code

69597

Product ID

69597-348_bef20e05-a18c-4d1f-96ce-e13072ffeebd

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

aspirin and omeprazole

Dosage form

TABLET, FILM COATED

Route

ORAL

Labeler

Basiem

Application

NDA205103

Marketing category

NDA

Marketing start

2019-04-10

Marketing end

0000-00-00

Substance

ASPIRIN; OMEPRAZOLE

Active strength

81 mg/1; mg/1

Pharmacologic 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

No

Listing certified through

2020-12-31

Current FDA listing

Historical FDA.report record