Amitriptyline Hydrochloride

Product NDC
71610-751
11-digit product format
716100751
Labeler code
71610
Product ID
71610-751_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
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
71610-751-307161007513030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-751-30) 2023-11-13NoNoHistorical
71610-751-537161007515360 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-751-53) 2023-11-13NoNoHistorical
71610-751-607161007516090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-751-60) 2023-11-13NoNoHistorical
71610-751-8071610075180180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-751-80) 2023-11-13NoNoHistorical

Related DailyMed Labels

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