Omeprazole

Product NDC

10544-295

11-digit product format

105440295

Labeler code

10544

Product ID

10544-295_11a46141-f467-0131-e054-00144ff88e88

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

omeprazole

Dosage form

CAPSULE, DELAYED RELEASE

Route

ORAL

Labeler

Blenheim Pharmacal, Inc.

Application

ANDA075876

Marketing category

ANDA

Marketing start

2013-09-30

Marketing end

0000-00-00

Substance

OMEPRAZOLE

Active strength

20 mg/1

Pharmacologic classes

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

NDC exclude flag

E

Listing certified through

2017-12-31

Current FDA listing

Historical FDA.report record