Amitriptyline Hydrochloride

Product NDC
71610-752
11-digit product format
716100752
Labeler code
71610
Product ID
71610-752_b68d1558-fe35-4440-9225-d0a5556a04b9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amitriptyline Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA089399
Marketing category
ANDA
Marketing start
1987-07-14
Substance
AMITRIPTYLINE HYDROCHLORIDE
Active strength
50 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
71610-752-307161007523030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-752-30) 2023-11-13NoNoHistorical
71610-752-537161007525360 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-752-53) 2023-11-13NoNoHistorical
71610-752-607161007526090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-752-60) 2023-11-13NoNoHistorical
71610-752-8071610075280180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-752-80) 2023-11-13NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
AMITRIPTYLINE HYDROCHLORIDE TABLETS USPAphena Pharma Solutions - Tennessee, LLC2023-11-14HUMAN PRESCRIPTION DRUG LABEL1