Esomeprazole Sodium

Product NDC

62756-509

11-digit product format

627560509

Labeler code

62756

Product ID

62756-509_c1aee218-5681-4f2e-9fd5-c356b0f81e41

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Esomeprazole Sodium

Dosage form

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

Route

INTRAVENOUS

Labeler

Sun Pharmaceutical Industries Limited

Application

ANDA200882

Marketing category

ANDA

Marketing start

2014-12-15

Marketing end

0000-00-00

Substance

ESOMEPRAZOLE SODIUM

Active strength

40 mg/5mL

Pharmacologic classes

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

NDC exclude flag

E

Listing certified through

2018-12-31

Current FDA listing

Historical FDA.report record