Omeprazole

Product NDC

63187-509

11-digit product format

631870509

Labeler code

63187

Product ID

63187-509_f7bcd032-9d40-4d94-b2f5-e519ab0b46a0

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Omeprazole

Dosage form

CAPSULE, DELAYED RELEASE

Route

ORAL

Labeler

Proficient Rx LP

Application

ANDA091672

Marketing category

ANDA

Marketing start

2014-10-31

Marketing end

0000-00-00

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

2020-12-31

Current FDA listing

Historical FDA.report record