Amitriptyline Hydrochloride

Product NDC
50090-2972
11-digit product format
500902972
Labeler code
50090
Product ID
50090-2972_8b647d06-1f11-4694-b4cc-14f0cdfb64c7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
amitriptyline hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA086009
Marketing category
ANDA
Marketing start
1978-04-10
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
2019-12-31
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
50090-2972-02020-01-31C16284748780-19d75b9d1-1299-f424-e053-dadaa90a57ce2868cad2-19c7-49bf-92d5-52094a782ec5

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-2972-0Amitriptyline Hydrochloride33 in 1 BOX, UNIT-DOSETABLET, FILM COATED335
50090-2972-0Amitriptyline Hydrochloride1 in 1 BLISTER PACKTABLET, FILM COATED15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-2972-0EA - Each50090-297238022c06-6210-47e7-ba6a-f904d7d93fd912019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-2972AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]5Legacy NDC, 2 package rows20190225_2868cad2-19c7-49bf-92d5-52094a782ec5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856845amitriptyline HCl 50 MG Oral TabletPSN2868cad2-19c7-49bf-92d5-52094a782ec55
856845amitriptyline hydrochloride 50 MG Oral TabletSCD2868cad2-19c7-49bf-92d5-52094a782ec55

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50090-2972-05009029720033 in 1 BOX, UNIT-DOSEHistorical