AMITRIPTYLINE HYDROCHLORIDE

Product NDC
50436-3710
11-digit product format
504363710
Labeler code
50436
Product ID
50436-3710_13270172-204d-4a53-8115-89fc1d4e004b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
AMITRIPTYLINE HYDROCHLORIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Unit Dose Services
Application
ANDA202446
Marketing category
ANDA
Marketing start
2014-12-05
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
2020-12-31
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50436-3710-12021-01-29C16284748780-1ba0f9c33-4554-a910-e053-dadaa90a0b85Amitriptyline Hydrochloride Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50436-3710-1AMITRIPTYLINE HYDROCHLORIDE30 in 1 BOTTLETABLET, FILM COATED3015

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-3710AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [UNIT DOSE SERVICES]15Legacy NDC, 1 package rows20190531_38c09cd6-53f1-48e0-bb10-319c0f7382e8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856845amitriptyline HCl 50 MG Oral TabletPSN38c09cd6-53f1-48e0-bb10-319c0f7382e815
856853amitriptyline HCl 75 MG Oral TabletPSN38c09cd6-53f1-48e0-bb10-319c0f7382e815
856845amitriptyline hydrochloride 50 MG Oral TabletSCD38c09cd6-53f1-48e0-bb10-319c0f7382e815
856853amitriptyline hydrochloride 75 MG Oral TabletSCD38c09cd6-53f1-48e0-bb10-319c0f7382e815

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50436-3710-15043637100130 in 1 BOTTLEHistorical