Amitriptyline hcl

Product NDC
61919-223
11-digit product format
619190223
Labeler code
61919
Product ID
61919-223_d6a9be39-ad74-984e-e053-2a95a90a4b96
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amitriptyline hcl
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Direct Rx
Application
ANDA202446
Marketing category
ANDA
Marketing start
2022-01-28
Marketing end
0000-00-00
Substance
AMITRIPTYLINE HYDROCHLORIDE
Active strength
100 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
61919-223-902025-01-30C16284748780-12cef2736-70f7-d83d-e063-dadaa90ab31fAmtriptyline hcl

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-223-90Amitriptyline hcl90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-223-90EA - Each61919-223530943ff-cbfd-49a0-ba90-699477ef241f12022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-223AMITRIPTYLINE HCL TABLET, FILM COATED [DIRECT RX]1Legacy NDC, 1 package rows20220201_d6a9be39-ad73-984e-e053-2a95a90a4b96.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856762amitriptyline HCl 100 MG Oral TabletPSNd6a9be39-ad73-984e-e053-2a95a90a4b961
856762amitriptyline hydrochloride 100 MG Oral TabletSCDd6a9be39-ad73-984e-e053-2a95a90a4b961

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61919-223-906191902239090 TABLET, FILM COATED in 1 BOTTLE (61919-223-90) 2022-01-280000-00-00NoNoCurrent