AMITRIPTYLINE HYDROCHLORIDE

Product NDC
72189-309
11-digit product format
721890309
Labeler code
72189
Product ID
72189-309_d44efada-eee3-747e-e053-2995a90af561
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
AMITRIPTYLINE HYDROCHLORIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
DirectRx
Application
ANDA202446
Marketing category
ANDA
Marketing start
2021-12-29
Marketing end
0000-00-00
Substance
AMITRIPTYLINE HYDROCHLORIDE
Active strength
75 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
72189-309-302025-01-30C16284748780-12cef2736-a872-d83d-e063-dadaa90ab31fAMITRIPTYLINE HYDROCHLORIDE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72189-309-30AMITRIPTYLINE HYDROCHLORIDE30 in 1 BOTTLETABLET, FILM COATED301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-309-30EA - Each72189-309c15d2304-f408-440e-94d8-e1d6a270234312022-02-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-309AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [DIRECTRX]1Legacy NDC, 1 package rows20211230_d44efada-eee2-747e-e053-2995a90af561.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856853amitriptyline HCl 75 MG Oral TabletPSNd44efada-eee2-747e-e053-2995a90af5611
856853amitriptyline hydrochloride 75 MG Oral TabletSCDd44efada-eee2-747e-e053-2995a90af5611

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72189-309-307218903093030 TABLET, FILM COATED in 1 BOTTLE (72189-309-30) 2021-12-290000-00-00NoNoCurrent