Esomeprazole Magnesium

Product NDC

68071-4212

11-digit product format

680714212

Labeler code

68071

Product ID

68071-4212_61fb3ced-b59a-421b-e053-2991aa0a5208

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Esomeprazole Magnesium

Dosage form

CAPSULE, DELAYED RELEASE

Route

ORAL

Labeler

NuCare Pharmaceuticals,Inc.

Application

ANDA205606

Marketing category

ANDA

Marketing start

2016-04-21

Marketing end

0000-00-00

Substance

ESOMEPRAZOLE MAGNESIUM DIHYDRATE

Active strength

40 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