Amitriptyline Hydrochloride

Product NDC
50090-6927
11-digit product format
500906927
Labeler code
50090
Product ID
50090-6927_4e8ca436-5c2b-447f-8f9b-4aeae9e16da6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amitriptyline Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA210086
Marketing category
ANDA
Marketing start
2021-08-25
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
50090-6927-05009069270090 TABLET, FILM COATED in 1 BOTTLE (50090-6927-0) 2023-12-14NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Amitriptyline Hydrochloride Tablets, USPA-S Medication Solutions2023-12-18HUMAN PRESCRIPTION DRUG LABEL1