Amitriptyline Hydrochloride

Product NDC
71335-9633
11-digit product format
713359633
Labeler code
71335
Product ID
71335-9633_62cc9302-bbfa-4d7c-bf63-d6cc2d10e026
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
25 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
71335-9633-071335963300120 TABLET, FILM COATED in 1 BOTTLE (71335-9633-0) 2023-02-06NoNoHistorical
71335-9633-17133596330120 TABLET, FILM COATED in 1 BOTTLE (71335-9633-1) 2023-02-06NoNoHistorical
71335-9633-27133596330230 TABLET, FILM COATED in 1 BOTTLE (71335-9633-2) 2023-02-06NoNoHistorical
71335-9633-371335963303100 TABLET, FILM COATED in 1 BOTTLE (71335-9633-3) 2023-02-06NoNoHistorical
71335-9633-47133596330460 TABLET, FILM COATED in 1 BOTTLE (71335-9633-4) 2023-02-06NoNoHistorical
71335-9633-57133596330550 TABLET, FILM COATED in 1 BOTTLE (71335-9633-5) 2023-02-06NoNoHistorical
71335-9633-67133596330690 TABLET, FILM COATED in 1 BOTTLE (71335-9633-6) 2023-02-06NoNoHistorical
71335-9633-77133596330745 TABLET, FILM COATED in 1 BOTTLE (71335-9633-7) 2023-02-06NoNoHistorical
71335-9633-87133596330828 TABLET, FILM COATED in 1 BOTTLE (71335-9633-8) 2023-02-06NoNoHistorical
71335-9633-97133596330956 TABLET, FILM COATED in 1 BOTTLE (71335-9633-9) 2023-02-06NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Amitriptyline Hydrochloride Tablets, USP Rx OnlyBryant Ranch Prepack2024-08-16HUMAN PRESCRIPTION DRUG LABEL102