AMITRIPTYLINE HYDROCHLORIDE

Product NDC
61919-240
11-digit product format
619190240
Labeler code
61919
Product ID
61919-240_96a48ad0-35e1-4dba-a564-2b0f4fb6939a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
AMITRIPTYLINE HYDROCHLORIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
DIRECT RX
Application
ANDA040218
Marketing category
ANDA
Marketing start
2015-01-01
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
61919-240-302020-01-31C16284748780-19d75b9d0-7ff3-f424-e053-dadaa90a57ceAMITRIPTYLINE HYDROCHLORIDE
61919-240-602020-01-31C16284748780-19d75b9d0-7ff3-f424-e053-dadaa90a57ceAMITRIPTYLINE HYDROCHLORIDE
61919-240-902020-01-31C16284748780-19d75b9d0-7ff3-f424-e053-dadaa90a57ceAMITRIPTYLINE HYDROCHLORIDE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-240-30AMITRIPTYLINE HYDROCHLORIDE30 in 1 BOTTLETABLET, FILM COATED304
61919-240-60AMITRIPTYLINE HYDROCHLORIDE60 in 1 BOTTLETABLET, FILM COATED604
61919-240-90AMITRIPTYLINE HYDROCHLORIDE90 in 1 BOTTLETABLET, FILM COATED904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-240-60EA - Each61919-240e4aab044-19d7-4f2b-a74d-55147c35460c12015-08-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMITRIPTYLINE HYDROCHLORIDEACTIVE INGREDIENT26LUD4JO9KAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX]4
AMITRIPTYLINEACTIVE MOIETY1806D8D52KAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX]4
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX]4
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX]4
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX]4
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX]4
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX]4
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-240AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX]4Legacy NDC, 3 package rows20151107_84600bfc-bcbf-4b37-a575-a6a99e2434fd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856845amitriptyline HCl 50 MG Oral TabletPSN84600bfc-bcbf-4b37-a575-a6a99e2434fd4
856845amitriptyline hydrochloride 50 MG Oral TabletSCD84600bfc-bcbf-4b37-a575-a6a99e2434fd4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
61919-240-306191902403030 in 1 BOTTLEHistorical
61919-240-606191902406060 in 1 BOTTLEHistorical
61919-240-906191902409090 in 1 BOTTLEHistorical