AMITRIPTYLINE HCL

Product NDC
72189-420
11-digit product format
721890420
Labeler code
72189
Product ID
72189-420_2c4d06ff-9f7a-48ac-e063-6394a90a6b9d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
AMITRIPTYLINE HCL
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Direct_Rx
Application
ANDA214548
Marketing category
ANDA
Marketing start
2023-02-07
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
72189-420-307218904203030 TABLET, FILM COATED in 1 BOTTLE (72189-420-30) 2023-02-07NoNoHistorical
72189-420-607218904206060 TABLET, FILM COATED in 1 BOTTLE (72189-420-60) 2023-02-07NoNoHistorical
72189-420-907218904209090 TABLET, FILM COATED in 1 BOTTLE (72189-420-90) 2023-02-07NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
AMITRIPTYLINE HCLDirect_Rx2025-01-22HUMAN PRESCRIPTION DRUG LABEL6