Amitriptyline Hydrochloride

Product NDC
70518-3979
11-digit product format
705183979
Labeler code
70518
Product ID
70518-3979_3bc7a9dc-12b5-32dc-e063-6294a90a1afc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amitriptyline Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA214548
Marketing category
ANDA
Marketing start
2024-01-10
Substance
AMITRIPTYLINE HYDROCHLORIDE
Active strength
75 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
70518-3979-07051839790090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3979-0) 2024-01-10NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Amitriptyline Hydrochloride Tablets, USP Rx OnlyREMEDYREPACK INC.2025-08-07HUMAN PRESCRIPTION DRUG LABEL3