ESOMEPRAZOLE STRONTIUM

Product NDC

52246-400

11-digit product format

522460400

Labeler code

52246

Product ID

52246-400_ccdb594f-adc9-4913-aa67-571bba802914

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

esomeprazole strontium

Dosage form

CAPSULE, DELAYED RELEASE

Route

ORAL

Labeler

ParaPRO LLC

Application

NDA202342

Marketing category

NDA

Marketing start

2016-10-28

Marketing end

0000-00-00

Substance

ESOMEPRAZOLE STRONTIUM

Active strength

49 mg/1

Pharmacologic classes

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

NDC exclude flag

No

Listing certified through

2019-12-31

Current FDA listing

Historical FDA.report record