FDA.reportPublic FDA data

AMITRIPTYLINE HYDROCHLORIDE

Product NDC
16729-176
11-digit product format
167290176
Labeler code
16729
Product ID
16729-176_387e8b29-cf4d-4859-e063-6294a90ad470
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
2014-12-26
Substance
AMITRIPTYLINE HYDROCHLORIDE
Active strength
150 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 HYDROCHLORIDE150 mg/1

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
16729-176-01AMITRIPTYLINE HYDROCHLORIDE100 in 1 BOTTLETABLET, FILM COATED1008
16729-176-10AMITRIPTYLINE HYDROCHLORIDE30 in 1 BOTTLETABLET, FILM COATED308
16729-176-17AMITRIPTYLINE HYDROCHLORIDE1000 in 1 BOTTLETABLET, FILM COATED10008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16729-176-01EA - Each16729-17672b3fdec-659f-4ca6-9228-283ce4dfba9612015-01-05

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
Amitriptyline HydrochlorideACTIVE INGREDIENT26LUD4JO9KAMITRIPTYLINE HYDROCHLORIDE TABLET [DIRECT RX]1
AMITRIPTYLINEACTIVE MOIETY1806D8D52KAMITRIPTYLINE HYDROCHLORIDE TABLET [DIRECT RX]1
Calcium SulfateINACTIVE INGREDIENTWAT0DDB505AMITRIPTYLINE HYDROCHLORIDE TABLET [DIRECT RX]1
Cellulose, MicrocrystallineINACTIVE INGREDIENTOP1R32D61UAMITRIPTYLINE HYDROCHLORIDE TABLET [DIRECT RX]1
Hydroxypropyl CelluloseINACTIVE INGREDIENTRFW2ET671PAMITRIPTYLINE HYDROCHLORIDE TABLET [DIRECT RX]1
HypromellosesINACTIVE INGREDIENT3NXW29V3WOAMITRIPTYLINE HYDROCHLORIDE TABLET [DIRECT RX]1
Magnesium StearateINACTIVE INGREDIENT70097M6I30AMITRIPTYLINE HYDROCHLORIDE TABLET [DIRECT RX]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AAMITRIPTYLINE HYDROCHLORIDE TABLET [DIRECT RX]1
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU4AMITRIPTYLINE HYDROCHLORIDE TABLET [DIRECT RX]1
Sodium Lauryl SulfateINACTIVE INGREDIENT368GB5141JAMITRIPTYLINE HYDROCHLORIDE TABLET [DIRECT RX]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2AMITRIPTYLINE HYDROCHLORIDE TABLET [DIRECT RX]1
Starch, CornINACTIVE INGREDIENTO8232NY3SJAMITRIPTYLINE HYDROCHLORIDE TABLET [DIRECT RX]1
TalcINACTIVE INGREDIENT7SEV7J4R1UAMITRIPTYLINE HYDROCHLORIDE TABLET [DIRECT RX]1
Titanium DioxideINACTIVE INGREDIENT15FIX9V2JPAMITRIPTYLINE HYDROCHLORIDE TABLET [DIRECT RX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16729-176AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE INC.]8Current NDC, Legacy 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
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
856773amitriptyline HCl 150 MG Oral TabletPSN6dc30652-39c8-49a9-b411-3d238bc0ef1a4
856834amitriptyline HCl 25 MG Oral TabletPSN6dc30652-39c8-49a9-b411-3d238bc0ef1a4
856773amitriptyline hydrochloride 150 MG Oral TabletSCD6dc30652-39c8-49a9-b411-3d238bc0ef1a4
856834amitriptyline hydrochloride 25 MG Oral TabletSCD6dc30652-39c8-49a9-b411-3d238bc0ef1a4
856773amitriptyline HCl 150 MG Oral TabletPSN9480586d-1e6b-2792-e053-2995a90adbb42
856773amitriptyline hydrochloride 150 MG Oral TabletSCD9480586d-1e6b-2792-e053-2995a90adbb42

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16729-176-0116729017601100 TABLET, FILM COATED in 1 BOTTLE (16729-176-01) 2014-12-260000-00-00NoNoCurrent
16729-176-101672901761030 in 1 BOTTLEHistorical
16729-176-17167290176171000 in 1 BOTTLEHistorical