FDA.reportPublic FDA data

AMITRIPTYLINE HYDROCHLORIDE

Product NDC
16729-172
11-digit product format
167290172
Labeler code
16729
Product ID
16729-172_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
25 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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
6f1277d7-db3a-63fa-be84-d390d1482706Product name120140508
aa9828b2-adf8-0dd3-9f6c-b68f39e467c1Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16729-172-01AMITRIPTYLINE HYDROCHLORIDE100 in 1 BOTTLETABLET, FILM COATED1008
16729-172-10AMITRIPTYLINE HYDROCHLORIDE30 in 1 BOTTLETABLET, FILM COATED308
16729-172-17AMITRIPTYLINE HYDROCHLORIDE1000 in 1 BOTTLETABLET, FILM COATED10008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16729-172-01EA - Each16729-172b5b77dd4-3f4f-42cd-893b-61a91a2fb39212015-01-05
16729-172-17EA - Each16729-1726ca10192-a56a-4040-904d-d40d150ec7b312015-01-05

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, FILM COATED [MEDSOURCE PHARMACEUTICALS]1
Amitriptyline HydrochlorideACTIVE INGREDIENT26LUD4JO9KAMITRIPTYLINE HYDROCHLORIDE TABLET [DIRECT RX]1
AMITRIPTYLINEACTIVE MOIETY1806D8D52KAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]1
AMITRIPTYLINEACTIVE MOIETY1806D8D52KAMITRIPTYLINE HYDROCHLORIDE TABLET [DIRECT RX]1
Calcium SulfateINACTIVE INGREDIENTWAT0DDB505AMITRIPTYLINE HYDROCHLORIDE TABLET [DIRECT RX]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]1
Cellulose, MicrocrystallineINACTIVE INGREDIENTOP1R32D61UAMITRIPTYLINE HYDROCHLORIDE TABLET [DIRECT RX]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]1
Hydroxypropyl CelluloseINACTIVE INGREDIENTRFW2ET671PAMITRIPTYLINE HYDROCHLORIDE TABLET [DIRECT RX]1
HypromellosesINACTIVE INGREDIENT3NXW29V3WOAMITRIPTYLINE HYDROCHLORIDE TABLET [DIRECT RX]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]1
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]1
Magnesium StearateINACTIVE INGREDIENT70097M6I30AMITRIPTYLINE HYDROCHLORIDE TABLET [DIRECT RX]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AAMITRIPTYLINE HYDROCHLORIDE TABLET [DIRECT RX]1
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]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, FILM COATED [MEDSOURCE PHARMACEUTICALS]1
TalcINACTIVE INGREDIENT7SEV7J4R1UAMITRIPTYLINE HYDROCHLORIDE TABLET [DIRECT RX]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]1
Titanium DioxideINACTIVE INGREDIENT15FIX9V2JPAMITRIPTYLINE HYDROCHLORIDE TABLET [DIRECT RX]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16729-172AMITRIPTYLINE 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
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 TabletPSN0f4a2a75-0d9e-4c36-9b0a-2962c4114a274
856834amitriptyline HCl 25 MG Oral TabletPSN6dc30652-39c8-49a9-b411-3d238bc0ef1a4
856834amitriptyline HCl 25 MG Oral TabletPSN6ac70bac-80e9-dc7b-e053-2a91aa0a61b54
856773amitriptyline hydrochloride 150 MG Oral TabletSCD6dc30652-39c8-49a9-b411-3d238bc0ef1a4
856834amitriptyline hydrochloride 25 MG Oral TabletSCD0f4a2a75-0d9e-4c36-9b0a-2962c4114a274
856834amitriptyline hydrochloride 25 MG Oral TabletSCD6ac70bac-80e9-dc7b-e053-2a91aa0a61b54
856834amitriptyline hydrochloride 25 MG Oral TabletSCD6dc30652-39c8-49a9-b411-3d238bc0ef1a4
856783amitriptyline HCl 10 MG Oral TabletPSN4b7fcf0c-6d2c-20b2-e054-00144ff8d46c2
856834amitriptyline HCl 25 MG Oral TabletPSNc13566db-4db3-3ee1-e053-2a95a90a82ad2
856834amitriptyline HCl 25 MG Oral TabletPSNafffd3fb-47c7-0a4c-e053-2995a90af20c2
856834amitriptyline HCl 25 MG Oral TabletPSN8e6eeec4-73fa-fd12-e053-2995a90a4ea82
856834amitriptyline HCl 25 MG Oral TabletPSN1db11285-b9c7-5060-e054-00144ff8d46c2
856834amitriptyline HCl 25 MG Oral TabletPSN4b7fcf0c-6d2c-20b2-e054-00144ff8d46c2
856783amitriptyline hydrochloride 10 MG Oral TabletSCD4b7fcf0c-6d2c-20b2-e054-00144ff8d46c2
856834amitriptyline hydrochloride 25 MG Oral TabletSCD4b7fcf0c-6d2c-20b2-e054-00144ff8d46c2
856834amitriptyline hydrochloride 25 MG Oral TabletSCD1db11285-b9c7-5060-e054-00144ff8d46c2
856834amitriptyline hydrochloride 25 MG Oral TabletSCD8e6eeec4-73fa-fd12-e053-2995a90a4ea82
856834amitriptyline hydrochloride 25 MG Oral TabletSCDafffd3fb-47c7-0a4c-e053-2995a90af20c2
856834amitriptyline hydrochloride 25 MG Oral TabletSCDc13566db-4db3-3ee1-e053-2a95a90a82ad2
856762amitriptyline HCl 100 MG Oral TabletPSN59774c8a-de96-53a6-e053-2991aa0a709f1
856834amitriptyline HCl 25 MG Oral TabletPSN59774c8a-de96-53a6-e053-2991aa0a709f1
856834amitriptyline HCl 25 MG Oral TabletPSNb29a161a-be0c-40a8-b68e-0071f58fcad01
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
856834amitriptyline hydrochloride 25 MG Oral TabletSCDb29a161a-be0c-40a8-b68e-0071f58fcad01
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
16729-172-0116729017201100 TABLET, FILM COATED in 1 BOTTLE (16729-172-01) 2014-12-050000-00-00NoNoCurrent
16729-172-101672901721030 in 1 BOTTLEHistorical
16729-172-17167290172171000 TABLET, FILM COATED in 1 BOTTLE (16729-172-17) 2014-12-050000-00-00NoNoCurrent