Amitriptyline HCL

Product NDC
72189-581
11-digit product format
721890581
Labeler code
72189
Product ID
72189-581_227affe9-36ef-2423-e063-6394a90a58f6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amitriptyline HCL
Dosage form
TABLET
Route
ORAL
Labeler
Direct_rx
Application
ANDA217411
Marketing category
ANDA
Marketing start
2024-09-19
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 formatDescriptionUnitsMarketing startSampleExclude flagStatus
72189-581-307218905813030 TABLET in 1 BOTTLE (72189-581-30) 30 tablet2024-09-19NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Amitriptyline HCLDirect_rx2024-09-19HUMAN PRESCRIPTION DRUG LABEL1