Amitriptyline Hydrochloride

Product NDC
50090-6418
11-digit product format
500906418
Labeler code
50090
Product ID
50090-6418_db7d6cf0-2227-4560-b9e7-16da4845c354
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amitriptyline Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
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
50090-6418-25009064180260 TABLET, FILM COATED in 1 BOTTLE (50090-6418-2) 2023-03-31NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Amitriptyline Hydrochloride Tablets, USP Rx OnlyA-S Medication Solutions2023-04-07HUMAN PRESCRIPTION DRUG LABEL1