Amitriptyline Hydrochloride

Product NDC
71335-2397
11-digit product format
713352397
Labeler code
71335
Product ID
71335-2397_59d04648-11e9-482b-90e7-d31d6e8703c5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amitriptyline Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA217411
Marketing category
ANDA
Marketing start
2023-06-10
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
71335-2397-071335239700120 TABLET in 1 BOTTLE (71335-2397-0) 120 tablet2024-05-29NoNoHistorical
71335-2397-17133523970120 TABLET in 1 BOTTLE (71335-2397-1) 20 tablet2024-05-29NoNoHistorical
71335-2397-27133523970230 TABLET in 1 BOTTLE (71335-2397-2) 30 tablet2024-05-29NoNoHistorical
71335-2397-371335239703100 TABLET in 1 BOTTLE (71335-2397-3) 100 tablet2024-05-29NoNoHistorical
71335-2397-47133523970460 TABLET in 1 BOTTLE (71335-2397-4) 60 tablet2024-05-29NoNoHistorical
71335-2397-57133523970550 TABLET in 1 BOTTLE (71335-2397-5) 50 tablet2024-05-29NoNoHistorical
71335-2397-67133523970690 TABLET in 1 BOTTLE (71335-2397-6) 90 tablet2024-05-29NoNoHistorical
71335-2397-77133523970745 TABLET in 1 BOTTLE (71335-2397-7) 45 tablet2024-05-29NoNoHistorical
71335-2397-87133523970828 TABLET in 1 BOTTLE (71335-2397-8) 28 tablet2024-05-29NoNoHistorical
71335-2397-97133523970956 TABLET in 1 BOTTLE (71335-2397-9) 56 tablet2024-05-29NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Amitriptyline Hydrochloride Tablets, USP Rx onlyBryant Ranch Prepack2024-08-16HUMAN PRESCRIPTION DRUG LABEL2