Amitriptyline Hydrochloride

Product NDC
0904-7410
11-digit product format
009047410
Labeler code
0904
Product ID
0904-7410_54771c13-f83b-4c28-b2ed-be967b14d388
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amitriptyline Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA217411
Marketing category
ANDA
Marketing start
2024-03-08
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 formatDescriptionUnitsMarketing startSampleExclude flagStatus
0904-7410-6100904741061100 BLISTER PACK in 1 CARTON (0904-7410-61) / 1 TABLET in 1 BLISTER PACK100 blister pack2024-03-08NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Amitriptyline Hydrochloride Tablets, USP Rx onlyMajor Pharmaceuticals2025-06-27HUMAN PRESCRIPTION DRUG LABEL2