Amitriptyline Hydrochloride

Product NDC
50090-5754
11-digit product format
500905754
Labeler code
50090
Product ID
50090-5754_4559c206-8ef6-408a-b646-34cdd2dacf1d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amitriptyline Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA085968
Marketing category
ANDA
Marketing start
1977-11-29
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
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-5754-02023-01-30C16284748780-1f386c649-b6c2-0266-e053-dadaa90a7c1aAmitriptyline Hydrochloride Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5754-0Amitriptyline Hydrochloride1 in 1 BLISTER PACKTABLET, FILM COATED11
50090-5754-0Amitriptyline Hydrochloride33 in 1 CARTONTABLET, FILM COATED331

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5754AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]1Legacy NDC, 2 package rows20211007_5fb87299-fca3-4303-8931-d9dfcaf4aa06.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856845amitriptyline HCl 50 MG Oral TabletPSN5fb87299-fca3-4303-8931-d9dfcaf4aa061
856845amitriptyline hydrochloride 50 MG Oral TabletSCD5fb87299-fca3-4303-8931-d9dfcaf4aa061

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5754-05009057540033 BLISTER PACK in 1 CARTON (50090-5754-0) > 1 TABLET, FILM COATED in 1 BLISTER PACK33 blister pack2021-09-300000-00-00NoNoCurrent