Amitriptyline Hydrochloride

Product NDC

51079-563

11-digit product format

510790563

Labeler code

51079

Product ID

51079-563_9c31c7a6-1afe-d3bb-e053-2995a90a6d7d

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

amitriptyline hydrochloride

Dosage form

TABLET, FILM COATED

Route

ORAL

Labeler

Mylan Institutional Inc.

Application

ANDA086009

Marketing category

ANDA

Marketing start

1994-12-13

Marketing end

2020-05-31

Substance

AMITRIPTYLINE HYDROCHLORIDE

Active strength

100 mg/1

Pharmacologic classes

Tricyclic Antidepressant [EPC]

NDC exclude flag

No

Listing certified through

0000-00-00

Current FDA listing

Historical FDA.report record