Amitriptyline Hydrochloride

Product NDC

55289-016

11-digit product format

552890016

Labeler code

55289

Product ID

55289-016_7bd5e617-43b4-597a-e053-2a91aa0a3c1c

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Amitriptyline Hydrochloride

Dosage form

TABLET, FILM COATED

Route

ORAL

Labeler

PD-Rx Pharmaceuticals, Inc.

Application

ANDA040218

Marketing category

ANDA

Marketing start

1997-09-11

Marketing end

0000-00-00

Substance

AMITRIPTYLINE HYDROCHLORIDE

Active strength

50 mg/1

Pharmacologic classes

Tricyclic Antidepressant [EPC]

NDC exclude flag

No

Listing certified through

2019-12-31

Current FDA listing

Historical FDA.report record