Omeprazole

Product NDC

0093-5294

11-digit product format

000935294

Labeler code

0093

Product ID

0093-5294_74764042-44bb-4b8b-b062-16675650a6aa

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Omeprazole

Dosage form

CAPSULE, DELAYED RELEASE PELLETS

Route

ORAL

Labeler

Teva Pharmaceuticals USA, Inc.

Application

ANDA204661

Marketing category

ANDA

Marketing start

2017-08-08

Marketing end

2020-05-31

Substance

OMEPRAZOLE

Active strength

40 mg/1

Pharmacologic classes

Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]

NDC exclude flag

No

Listing certified through

0000-00-00

Current FDA listing

Historical FDA.report record