Amitriptyline Hydrochloride

Product NDC
71335-2398
11-digit product format
713352398
Labeler code
71335
Product ID
71335-2398_88f5f6fe-0f20-4b8e-aff4-a32aa5be8635
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
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 formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2398-17133523980130 TABLET in 1 BOTTLE (71335-2398-1) 30 tablet2024-05-29NoNoHistorical
71335-2398-271335239802100 TABLET in 1 BOTTLE (71335-2398-2) 100 tablet2024-05-29NoNoHistorical
71335-2398-37133523980328 TABLET in 1 BOTTLE (71335-2398-3) 28 tablet2024-05-29NoNoHistorical
71335-2398-47133523980460 TABLET in 1 BOTTLE (71335-2398-4) 60 tablet2024-05-29NoNoHistorical
71335-2398-57133523980590 TABLET in 1 BOTTLE (71335-2398-5) 90 tablet2024-05-29NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Amitriptyline Hydrochloride Tablets, USP Rx onlyBryant Ranch Prepack2024-05-29HUMAN PRESCRIPTION DRUG LABEL1