Amitriptyline HCL

Product NDC
72189-588
11-digit product format
721890588
Labeler code
72189
Product ID
72189-588_23ab2afe-06c2-fa61-e063-6394a90abcf8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amitriptyline HCL
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Direct_Rx
Application
ANDA213999
Marketing category
ANDA
Marketing start
2024-10-04
Substance
AMITRIPTYLINE HYDROCHLORIDE
Active strength
150 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
72189-588-307218905883030 TABLET, FILM COATED in 1 BOTTLE (72189-588-30) 2024-10-04NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Amitriptyline HCLDirect_Rx2024-10-04HUMAN PRESCRIPTION DRUG LABEL1