ELESTAT

Product NDC

0023-9201

11-digit product format

000239201

Labeler code

0023

Product ID

0023-9201_ff305ef3-04d0-4b77-a89f-4f0496ea1f14

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

epinastine hydrochloride

Dosage form

SOLUTION/ DROPS

Route

OPHTHALMIC

Labeler

Allergan, Inc.

Application

NDA021565

Marketing category

NDA

Marketing start

2004-01-19

Marketing end

0000-00-00

Substance

EPINASTINE HYDROCHLORIDE

Active strength

1 mg/mL

Pharmacologic classes

Adrenergic Agonists [MoA],Adrenergic Receptor Agonist [EPC],Decreased Histamine Release [PE],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Inhibitor [EPC]

NDC exclude flag

No

Listing certified through

2020-12-31

Current FDA listing

Historical FDA.report record