Amitriptyline Hydrochloride

Product NDC
71335-9685
11-digit product format
713359685
Labeler code
71335
Product ID
71335-9685_3544c791-cd59-40cf-e063-6394a90a362b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amitriptyline Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA214548
Marketing category
ANDA
Marketing start
2021-05-26
Substance
AMITRIPTYLINE HYDROCHLORIDE
Active strength
75 mg/1
Pharmacologic classes
Tricyclic Antidepressant [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
26LUD4JO9KAMITRIPTYLINE HYDROCHLORIDE549-18-8AMITRIPTYLINE HYDROCHLORIDE

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-9685-17133596850130 TABLET, FILM COATED in 1 BOTTLE (71335-9685-1) 2023-04-11NoNoHistorical
71335-9685-271335968502100 TABLET, FILM COATED in 1 BOTTLE (71335-9685-2) 2023-04-11NoNoHistorical
71335-9685-37133596850328 TABLET, FILM COATED in 1 BOTTLE (71335-9685-3) 2023-04-11NoNoHistorical
71335-9685-47133596850460 TABLET, FILM COATED in 1 BOTTLE (71335-9685-4) 2023-04-11NoNoHistorical
71335-9685-57133596850590 TABLET, FILM COATED in 1 BOTTLE (71335-9685-5) 2023-04-11NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Amitriptyline Hydrochloride Tablets, USP Rx OnlyBryant Ranch Prepack2025-05-16HUMAN PRESCRIPTION DRUG LABEL101