Amitriptyline Hydrochloride

Product NDC
50090-3985
11-digit product format
500903985
Labeler code
50090
Product ID
50090-3985_b5560679-0c76-407b-9dee-86c38cf1f351
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amitriptyline Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA210086
Marketing category
ANDA
Marketing start
2017-12-26
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
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
50090-3985-02023-01-30C16284748780-1f386c649-9a04-0266-e053-dadaa90a7c1aAmitriptyline Hydrochloride Tablets, USP
50090-3985-22023-01-30C16284748780-1f386c649-9a04-0266-e053-dadaa90a7c1aAmitriptyline Hydrochloride Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3985-0Amitriptyline Hydrochloride100 in 1 BOTTLETABLET, FILM COATED1006
50090-3985-2Amitriptyline Hydrochloride60 in 1 BOTTLETABLET, FILM COATED606

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3985-2EA - Each50090-39858a6b1006-bb07-4310-86c6-186e1af9a3e912021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3985AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]6Legacy NDC, 2 package rows20210417_7b52fa02-2dbe-4b0f-a7e5-6c17982c575d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856762amitriptyline HCl 100 MG Oral TabletPSN7b52fa02-2dbe-4b0f-a7e5-6c17982c575d6
856762amitriptyline hydrochloride 100 MG Oral TabletSCD7b52fa02-2dbe-4b0f-a7e5-6c17982c575d6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-3985-050090398500100 TABLET, FILM COATED in 1 BOTTLE (50090-3985-0) 2018-12-170000-00-00NoNoCurrent
50090-3985-25009039850260 TABLET, FILM COATED in 1 BOTTLE (50090-3985-2) 2018-12-170000-00-00NoNoCurrent