Amitriptyline Hydrochloride

Product NDC
68071-2843
11-digit product format
680712843
Labeler code
68071
Product ID
68071-2843_ea3c7866-f531-8bcb-e053-2995a90ac00c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amitriptyline Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA214548
Marketing category
ANDA
Marketing start
2021-05-26
Marketing end
0000-00-00
Substance
AMITRIPTYLINE HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Tricyclic Antidepressant [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
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
68071-2843-32025-01-30C16284748780-12cef2736-953a-d83d-e063-dadaa90ab31fAmitriptyline Hydrochloride Tablets, USP Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2843-3Amitriptyline Hydrochloride30 in 1 BOTTLETABLET, FILM COATED301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2843AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.]1Legacy NDC, 1 package rows20221005_ea3c75d9-1718-32e1-e053-2a95a90a3cfe.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856783amitriptyline HCl 10 MG Oral TabletPSNea3c75d9-1718-32e1-e053-2a95a90a3cfe1
856783amitriptyline hydrochloride 10 MG Oral TabletSCDea3c75d9-1718-32e1-e053-2a95a90a3cfe1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-2843-36807128430330 TABLET, FILM COATED in 1 BOTTLE (68071-2843-3) 2022-10-040000-00-00NoNoCurrent