FDA.reportPublic FDA data

AMITRIPTYLINE HYDROCHLORIDE

Product NDC
16729-173
11-digit product format
167290173
Labeler code
16729
Product ID
16729-173_ecb5bd74-ba7f-6546-e053-2a95a90a0a30
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
AMITRIPTYLINE HYDROCHLORIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Accord Healthcare Inc.
Application
ANDA202446
Marketing category
ANDA
Marketing start
2014-12-05
Marketing end
0000-00-00
Substance
AMITRIPTYLINE HYDROCHLORIDE
Active strength
50 mg/1
Pharmacologic classes
Tricyclic Antidepressant [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16729-173-01AMITRIPTYLINE HYDROCHLORIDE100 in 1 BOTTLETABLET, FILM COATED1008
16729-173-10AMITRIPTYLINE HYDROCHLORIDE30 in 1 BOTTLETABLET, FILM COATED308
16729-173-17AMITRIPTYLINE HYDROCHLORIDE1000 in 1 BOTTLETABLET, FILM COATED10008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16729-173-01EA - Each16729-173c1b2fcfa-75bf-4a98-a9c1-815eaae0961212015-01-05
16729-173-17EA - Each16729-173697525ce-38fd-4e2c-a316-d1604b90e6e312015-01-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMITRIPTYLINE HYDROCHLORIDEACTIVE INGREDIENT26LUD4JO9KAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE INC.]3
AMITRIPTYLINEACTIVE MOIETY1806D8D52KAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE INC.]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE INC.]3
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE INC.]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE INC.]3
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE INC.]3
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE INC.]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE INC.]3
TALCINACTIVE INGREDIENT7SEV7J4R1UAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE INC.]3
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16729-173AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE INC.]8Legacy NDC, 3 package rows20221106_1e6d2c80-fbc8-444e-bdd3-6a91fe1b95bd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856783amitriptyline HCl 10 MG Oral TabletPSN76d3f4fd-4603-4cfc-94ab-2e62c0bdae7522
856762amitriptyline HCl 100 MG Oral TabletPSN76d3f4fd-4603-4cfc-94ab-2e62c0bdae7522
856773amitriptyline HCl 150 MG Oral TabletPSN76d3f4fd-4603-4cfc-94ab-2e62c0bdae7522
856834amitriptyline HCl 25 MG Oral TabletPSN76d3f4fd-4603-4cfc-94ab-2e62c0bdae7522
856845amitriptyline HCl 50 MG Oral TabletPSN76d3f4fd-4603-4cfc-94ab-2e62c0bdae7522
856853amitriptyline HCl 75 MG Oral TabletPSN76d3f4fd-4603-4cfc-94ab-2e62c0bdae7522
856783amitriptyline hydrochloride 10 MG Oral TabletSCD76d3f4fd-4603-4cfc-94ab-2e62c0bdae7522
856762amitriptyline hydrochloride 100 MG Oral TabletSCD76d3f4fd-4603-4cfc-94ab-2e62c0bdae7522
856773amitriptyline hydrochloride 150 MG Oral TabletSCD76d3f4fd-4603-4cfc-94ab-2e62c0bdae7522
856834amitriptyline hydrochloride 25 MG Oral TabletSCD76d3f4fd-4603-4cfc-94ab-2e62c0bdae7522
856845amitriptyline hydrochloride 50 MG Oral TabletSCD76d3f4fd-4603-4cfc-94ab-2e62c0bdae7522
856853amitriptyline hydrochloride 75 MG Oral TabletSCD76d3f4fd-4603-4cfc-94ab-2e62c0bdae7522
856845amitriptyline HCl 50 MG Oral TabletPSN38c09cd6-53f1-48e0-bb10-319c0f7382e815
856853amitriptyline HCl 75 MG Oral TabletPSN38c09cd6-53f1-48e0-bb10-319c0f7382e815
856845amitriptyline hydrochloride 50 MG Oral TabletSCD38c09cd6-53f1-48e0-bb10-319c0f7382e815
856853amitriptyline hydrochloride 75 MG Oral TabletSCD38c09cd6-53f1-48e0-bb10-319c0f7382e815
856783amitriptyline HCl 10 MG Oral TabletPSN1e6d2c80-fbc8-444e-bdd3-6a91fe1b95bd8
856762amitriptyline HCl 100 MG Oral TabletPSN1e6d2c80-fbc8-444e-bdd3-6a91fe1b95bd8
856773amitriptyline HCl 150 MG Oral TabletPSN1e6d2c80-fbc8-444e-bdd3-6a91fe1b95bd8
856834amitriptyline HCl 25 MG Oral TabletPSN1e6d2c80-fbc8-444e-bdd3-6a91fe1b95bd8
856845amitriptyline HCl 50 MG Oral TabletPSN1e6d2c80-fbc8-444e-bdd3-6a91fe1b95bd8
856853amitriptyline HCl 75 MG Oral TabletPSN1e6d2c80-fbc8-444e-bdd3-6a91fe1b95bd8
856783amitriptyline hydrochloride 10 MG Oral TabletSCD1e6d2c80-fbc8-444e-bdd3-6a91fe1b95bd8
856762amitriptyline hydrochloride 100 MG Oral TabletSCD1e6d2c80-fbc8-444e-bdd3-6a91fe1b95bd8
856773amitriptyline hydrochloride 150 MG Oral TabletSCD1e6d2c80-fbc8-444e-bdd3-6a91fe1b95bd8
856834amitriptyline hydrochloride 25 MG Oral TabletSCD1e6d2c80-fbc8-444e-bdd3-6a91fe1b95bd8
856845amitriptyline hydrochloride 50 MG Oral TabletSCD1e6d2c80-fbc8-444e-bdd3-6a91fe1b95bd8
856853amitriptyline hydrochloride 75 MG Oral TabletSCD1e6d2c80-fbc8-444e-bdd3-6a91fe1b95bd8
856845amitriptyline HCl 50 MG Oral TabletPSN48a65c4c-bfee-1584-e054-00144ff88e884
856845amitriptyline hydrochloride 50 MG Oral TabletSCD48a65c4c-bfee-1584-e054-00144ff88e884
856845amitriptyline HCl 50 MG Oral TabletPSN8ee78d77-b5d0-1e6a-e053-2995a90ac6972
856845amitriptyline hydrochloride 50 MG Oral TabletSCD8ee78d77-b5d0-1e6a-e053-2995a90ac6972
856762amitriptyline HCl 100 MG Oral TabletPSN59774c8a-de96-53a6-e053-2991aa0a709f1
856834amitriptyline HCl 25 MG Oral TabletPSN59774c8a-de96-53a6-e053-2991aa0a709f1
856845amitriptyline HCl 50 MG Oral TabletPSN7413e5b6-908f-46a7-812e-3951e21b918a1
856845amitriptyline HCl 50 MG Oral TabletPSN59774c8a-de96-53a6-e053-2991aa0a709f1
856762amitriptyline hydrochloride 100 MG Oral TabletSCD59774c8a-de96-53a6-e053-2991aa0a709f1
856834amitriptyline hydrochloride 25 MG Oral TabletSCD59774c8a-de96-53a6-e053-2991aa0a709f1
856845amitriptyline hydrochloride 50 MG Oral TabletSCD7413e5b6-908f-46a7-812e-3951e21b918a1
856845amitriptyline hydrochloride 50 MG Oral TabletSCD59774c8a-de96-53a6-e053-2991aa0a709f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16729-173-0116729017301100 TABLET, FILM COATED in 1 BOTTLE (16729-173-01) 2014-12-050000-00-00NoNoCurrent
16729-173-101672901731030 in 1 BOTTLEHistorical
16729-173-17167290173171000 TABLET, FILM COATED in 1 BOTTLE (16729-173-17) 2014-12-150000-00-00NoNoCurrent