Omeprazole

Product NDC

65084-445

11-digit product format

650840445

Labeler code

65084

Product ID

65084-445_ec968ca6-4f9a-450b-bd9f-50a0969386eb

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

omeprazole

Dosage form

CAPSULE, DELAYED RELEASE

Route

ORAL

Labeler

McKesson Corporation dba RX Pak

Application

ANDA075410

Marketing category

ANDA

Marketing start

2009-01-23

Marketing end

0000-00-00

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

2020-12-31

Current FDA listing

Historical FDA.report record