Esomeprazole Magnesium

Product NDC

68462-557

11-digit product format

684620557

Labeler code

68462

Product ID

68462-557_e4a8ebf5-6397-4a47-8a78-f10abbd15c75

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Esomeprazole Magnesium

Dosage form

CAPSULE, DELAYED RELEASE PELLETS

Route

ORAL

Labeler

Glenmark Pharmaceuticals Inc., USA

Application

ANDA209495

Marketing category

ANDA

Marketing start

2019-05-13

Marketing end

0000-00-00

Substance

ESOMEPRAZOLE MAGNESIUM

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