Amitriptyline Hydrochloride

Product NDC
50090-3784
11-digit product format
500903784
Labeler code
50090
Product ID
50090-3784_57b2f786-4dbc-457c-ae5e-8ca637e0ee14
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amitriptyline Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA210086
Marketing category
ANDA
Marketing start
2017-12-26
Marketing end
0000-00-00
Substance
AMITRIPTYLINE HYDROCHLORIDE
Active strength
50 mg/1
Pharmacologic classes
Tricyclic Antidepressant [EPC]
NDC exclude flag
No
Listing certified through
2021-12-31
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
50090-3784-0Amitriptyline Hydrochloride100 in 1 BOTTLETABLET, FILM COATED1005
50090-3784-1Amitriptyline Hydrochloride30 in 1 BOTTLE, PLASTICTABLET, FILM COATED305
50090-3784-2Amitriptyline Hydrochloride60 in 1 BOTTLE, PLASTICTABLET, FILM COATED605
50090-3784-5Amitriptyline Hydrochloride90 in 1 BOTTLE, PLASTICTABLET, FILM COATED905

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3784AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]5Legacy NDC, 4 package rows20200516_9700247a-0a15-41e1-983d-6426cff31d82.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856845amitriptyline HCl 50 MG Oral TabletPSN9700247a-0a15-41e1-983d-6426cff31d825
856845amitriptyline hydrochloride 50 MG Oral TabletSCD9700247a-0a15-41e1-983d-6426cff31d825

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-3784-050090378400100 TABLET, FILM COATED in 1 BOTTLE (50090-3784-0) 2018-11-070000-00-00NoNoCurrent
50090-3784-15009037840130 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-3784-1) 2017-12-260000-00-00NoNoCurrent
50090-3784-25009037840260 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-3784-2) 2017-12-260000-00-00NoNoCurrent
50090-3784-55009037840590 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-3784-5) 2017-12-260000-00-00NoNoCurrent