Amitriptyline Hydrochloride

Product NDC
64725-1488
11-digit product format
647251488
Labeler code
64725
Product ID
64725-1488_15986746-62f9-4539-969a-da2396a26bcc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amitriptyline Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
TYA Pharmaceuticals
Application
ANDA085968
Marketing category
ANDA
Marketing start
1977-11-29
Marketing end
0000-00-00
Substance
AMITRIPTYLINE HYDROCHLORIDE
Active strength
50 mg/1
Pharmacologic classes
Tricyclic Antidepressant [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
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
64725-1488-12019-11-27C16284748780-19855e2a2-3df8-60a7-e053-dbdaa90a05bdAmitriptyline Hydrochloride Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64725-1488-1Amitriptyline Hydrochloride100 in 1 BOTTLETABLET, FILM COATED1005

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMITRIPTYLINE HYDROCHLORIDEACTIVE INGREDIENT26LUD4JO9KAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [TYA PHARMACEUTICALS]5
AMITRIPTYLINEACTIVE MOIETY1806D8D52KAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [TYA PHARMACEUTICALS]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [TYA PHARMACEUTICALS]5
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [TYA PHARMACEUTICALS]5
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [TYA PHARMACEUTICALS]5
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [TYA PHARMACEUTICALS]5
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [TYA PHARMACEUTICALS]5
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [TYA PHARMACEUTICALS]5
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [TYA PHARMACEUTICALS]5
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [TYA PHARMACEUTICALS]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [TYA PHARMACEUTICALS]5
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [TYA PHARMACEUTICALS]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [TYA PHARMACEUTICALS]5
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [TYA PHARMACEUTICALS]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [TYA PHARMACEUTICALS]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64725-1488AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [TYA PHARMACEUTICALS]5Legacy NDC, 1 package rows20140926_d3eb7cb8-128d-4876-91ec-a56c0123ac90.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856834amitriptyline HCl 25 MG Oral TabletPSNd3eb7cb8-128d-4876-91ec-a56c0123ac905
856845amitriptyline HCl 50 MG Oral TabletPSNd3eb7cb8-128d-4876-91ec-a56c0123ac905
856834amitriptyline hydrochloride 25 MG Oral TabletSCDd3eb7cb8-128d-4876-91ec-a56c0123ac905
856845amitriptyline hydrochloride 50 MG Oral TabletSCDd3eb7cb8-128d-4876-91ec-a56c0123ac905

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
64725-1488-164725148801100 in 1 BOTTLEHistorical