AMITRIPTYLINE HYDROCHLORIDE

Product NDC
50090-3564
11-digit product format
500903564
Labeler code
50090
Product ID
50090-3564_f4f09800-e299-40ce-8637-9180a886de99
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
AMITRIPTYLINE HYDROCHLORIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA202446
Marketing category
ANDA
Marketing start
2014-12-05
Substance
AMITRIPTYLINE HYDROCHLORIDE
Active strength
100 mg/1
Pharmacologic classes
Tricyclic Antidepressant [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
AMITRIPTYLINE HYDROCHLORIDE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMITRIPTYLINE HYDROCHLORIDE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii26LUD4JO9K
Rxcui856762

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3564-2AMITRIPTYLINE HYDROCHLORIDE60 in 1 BOTTLETABLET, FILM COATED6010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3564-2EA - Each50090-35649f65e842-448e-4e3a-a118-c0ddbbe3115a12021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3564AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]10Current NDC, Legacy NDC, 1 package rows20230105_9440dd10-2f0d-42a7-a037-3ab8729708f6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856762amitriptyline HCl 100 MG Oral TabletPSN9440dd10-2f0d-42a7-a037-3ab8729708f610
856762amitriptyline hydrochloride 100 MG Oral TabletSCD9440dd10-2f0d-42a7-a037-3ab8729708f610

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-3564-25009035640260 TABLET, FILM COATED in 1 BOTTLE (50090-3564-2) 2018-08-300000-00-00NoNoCurrent