AMITRIPTYLINE HYDROCHLORIDE

Product NDC
51655-121
11-digit product format
516550121
Labeler code
51655
Product ID
51655-121_c13566ef-16fd-60aa-e053-2a95a90a67c9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
AMITRIPTYLINE HYDROCHLORIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Northwind Pharmaceuticals
Application
ANDA202446
Marketing category
ANDA
Marketing start
2020-09-03
Marketing end
0000-00-00
Substance
AMITRIPTYLINE HYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Tricyclic Antidepressant [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e5006e90-7f2e-4341-bcdb-f83027a8fc39Product name620240611
6f1277d7-db3a-63fa-be84-d390d1482706Product name120140508
aa9828b2-adf8-0dd3-9f6c-b68f39e467c1Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51655-121-26AMITRIPTYLINE HYDROCHLORIDE90 in 1 BOTTLE, PLASTICTABLET, FILM COATED902
51655-121-52AMITRIPTYLINE HYDROCHLORIDE30 in 1 BOTTLE, PLASTICTABLET, FILM COATED302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-121AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS]2Legacy NDC, 2 package rows20230324_c13566db-4db3-3ee1-e053-2a95a90a82ad.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856834amitriptyline HCl 25 MG Oral TabletPSNc13566db-4db3-3ee1-e053-2a95a90a82ad2
856834amitriptyline hydrochloride 25 MG Oral TabletSCDc13566db-4db3-3ee1-e053-2a95a90a82ad2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
51655-121-265165501212690 in 1 BOTTLE, PLASTICHistorical
51655-121-525165501215230 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-121-52) 2020-09-030000-00-00NoNoCurrent