Amitriptyline Hydrochloride

Product NDC
60760-556
11-digit product format
607600556
Labeler code
60760
Product ID
60760-556_450e40f4-fa23-ad42-e063-6294a90ac458
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amitriptyline Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
ST. MARY'S MEDICAL PARK PHARMACY
Application
ANDA214548
Marketing category
ANDA
Marketing start
2022-07-13
Substance
AMITRIPTYLINE HYDROCHLORIDE
Active strength
10 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
60760-556-156076005561515 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-556-15) 2022-07-13NoNoHistorical
60760-556-906076005569090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-556-90) 2025-05-13NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Amitriptyline Hydrochloride Tablets, USP Rx OnlyST. MARY'S MEDICAL PARK PHARMACY2025-12-03HUMAN PRESCRIPTION DRUG LABEL3