Omeprazole

Product NDC

0378-5211

11-digit product format

003785211

Labeler code

0378

Product ID

0378-5211_54a04f22-d835-47c6-b249-252b68f9074a

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

omeprazole

Dosage form

CAPSULE, DELAYED RELEASE

Route

ORAL

Labeler

Mylan Pharmaceuticals Inc.

Application

ANDA075876

Marketing category

ANDA

Marketing start

2003-08-04

Marketing end

2019-05-31

Substance

OMEPRAZOLE

Active strength

10 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