Amitriptyline Hydrochloride

Product NDC
82804-092
11-digit product format
828040092
Labeler code
82804
Product ID
82804-092_61133866-b01c-4278-93fb-4564c1b56e54
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amitriptyline Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA214548
Marketing category
ANDA
Marketing start
2021-05-26
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
82804-092-308280400923030 TABLET, FILM COATED in 1 BOTTLE (82804-092-30) 2024-03-29NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Amitriptyline Hydrochloride Tablets, USP Rx OnlyProficient Rx LP2024-03-01HUMAN PRESCRIPTION DRUG LABEL1