Amitriptyline Hydrochloride

Product NDC
71335-9668
11-digit product format
713359668
Labeler code
71335
Product ID
71335-9668_3534db88-4b57-437f-e063-6294a90aafaa
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
100 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
71335-9668-17133596680130 TABLET, FILM COATED in 1 BOTTLE (71335-9668-1) 2023-03-27NoNoHistorical
71335-9668-27133596680260 TABLET, FILM COATED in 1 BOTTLE (71335-9668-2) 2023-03-27NoNoHistorical
71335-9668-37133596680390 TABLET, FILM COATED in 1 BOTTLE (71335-9668-3) 2023-03-27NoNoHistorical
71335-9668-471335966804180 TABLET, FILM COATED in 1 BOTTLE (71335-9668-4) 2023-03-27NoNoHistorical
71335-9668-57133596680528 TABLET, FILM COATED in 1 BOTTLE (71335-9668-5) 2023-03-27NoNoHistorical
71335-9668-671335966806120 TABLET, FILM COATED in 1 BOTTLE (71335-9668-6) 2023-03-27NoNoHistorical
71335-9668-77133596680718 TABLET, FILM COATED in 1 BOTTLE (71335-9668-7) 2023-03-27NoNoHistorical
71335-9668-8713359668088 TABLET, FILM COATED in 1 BOTTLE (71335-9668-8) 2023-03-27NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Amitriptyline Hydrochloride Tablets, USP Rx OnlyBryant Ranch Prepack2025-05-15HUMAN PRESCRIPTION DRUG LABEL101