Amitriptyline Hydrochloride

Product NDC
67046-016
11-digit product format
670460016
Labeler code
67046
Product ID
67046-016_c958b45e-7ca1-400a-b723-56e8c3aa98d8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amitriptyline Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Contract Pharmacy Services-PA
Application
ANDA040218
Marketing category
ANDA
Marketing start
1997-09-11
Marketing end
0000-00-00
Substance
AMITRIPTYLINE HYDROCHLORIDE
Active strength
75 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
67046-016-302019-10-29C16284748780-1960f7f55-cda9-8e05-e053-dbdaa90a074aAMITRIPTYLINE HYDROCHLORIDE TABLETS, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67046-016-30Amitriptyline Hydrochloride30 in 1 BLISTER PACKTABLET, FILM COATED301

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMITRIPTYLINE HYDROCHLORIDEACTIVE INGREDIENT26LUD4JO9KAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
AMITRIPTYLINEACTIVE MOIETY1806D8D52KAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1AAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-016AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1Legacy NDC, 1 package rows20110601_c958b45e-7ca1-400a-b723-56e8c3aa98d8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856762amitriptyline HCl 100 MG Oral TabletPSNc958b45e-7ca1-400a-b723-56e8c3aa98d81
856834amitriptyline HCl 25 MG Oral TabletPSNc958b45e-7ca1-400a-b723-56e8c3aa98d81
856845amitriptyline HCl 50 MG Oral TabletPSNc958b45e-7ca1-400a-b723-56e8c3aa98d81
856853amitriptyline HCl 75 MG Oral TabletPSNc958b45e-7ca1-400a-b723-56e8c3aa98d81
856762amitriptyline hydrochloride 100 MG Oral TabletSCDc958b45e-7ca1-400a-b723-56e8c3aa98d81
856834amitriptyline hydrochloride 25 MG Oral TabletSCDc958b45e-7ca1-400a-b723-56e8c3aa98d81
856845amitriptyline hydrochloride 50 MG Oral TabletSCDc958b45e-7ca1-400a-b723-56e8c3aa98d81
856853amitriptyline hydrochloride 75 MG Oral TabletSCDc958b45e-7ca1-400a-b723-56e8c3aa98d81

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
67046-016-306704600163030 in 1 BLISTER PACKHistorical