OMEPRAZOLE

Product NDC

51991-642

11-digit product format

519910642

Labeler code

51991

Product ID

51991-642_6b287a75-907f-4049-a798-c22b4cb79881

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

OMEPRAZOLE

Dosage form

CAPSULE, DELAYED RELEASE PELLETS

Route

ORAL

Labeler

Breckenridge Pharmaceutical, Inc.

Application

ANDA203481

Marketing category

ANDA

Marketing start

2017-07-03

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

2021-12-31

Current FDA listing

Historical FDA.report record