Esomeprazole Magnesium

Product NDC

68788-7623

11-digit product format

687887623

Labeler code

68788

Product ID

68788-7623_f75a77d3-1b62-4cc5-9dd7-67b28f47246c

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Esomeprazole Magnesium

Dosage form

CAPSULE, DELAYED RELEASE

Route

ORAL

Labeler

Preferred Pharmaceuticals, Inc.

Application

ANDA205606

Marketing category

ANDA

Marketing start

2016-04-21

Marketing end

0000-00-00

Substance

ESOMEPRAZOLE MAGNESIUM DIHYDRATE

Active strength

20 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