FDA.reportPublic FDA data

AMITRIPTYLINE HYDROCHLORIDE

Product NDC
16729-171
11-digit product format
167290171
Labeler code
16729
Product ID
16729-171_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
2014-12-05
Substance
AMITRIPTYLINE HYDROCHLORIDE
Active strength
10 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 HYDROCHLORIDE10 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
16729-171-01AMITRIPTYLINE HYDROCHLORIDE100 in 1 BOTTLETABLET, FILM COATED1008
16729-171-10AMITRIPTYLINE HYDROCHLORIDE30 in 1 BOTTLETABLET, FILM COATED308
16729-171-17AMITRIPTYLINE HYDROCHLORIDE1000 in 1 BOTTLETABLET, FILM COATED10008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16729-171-01EA - Each16729-17101c910ac-e802-470b-94a9-b769d71e908a12015-01-05
16729-171-17EA - Each16729-1719f689193-ba9b-4935-a2a7-71cb20ac924712015-01-05

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
16729-171AMITRIPTYLINE 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
856783amitriptyline HCl 10 MG Oral TabletPSNca66c2fc-6724-f4cd-e053-2995a90a42cf7
856783amitriptyline hydrochloride 10 MG Oral TabletSCDca66c2fc-6724-f4cd-e053-2995a90a42cf7
856783amitriptyline HCl 10 MG Oral TabletPSN9bfd3fb2-e862-48ec-b9af-6a71eacf7b515
856783amitriptyline HCl 10 MG Oral TabletPSNdf5aee40-ffa9-4cf3-ab5f-30253f43092b5
856783amitriptyline hydrochloride 10 MG Oral TabletSCD9bfd3fb2-e862-48ec-b9af-6a71eacf7b515
856783amitriptyline hydrochloride 10 MG Oral TabletSCDdf5aee40-ffa9-4cf3-ab5f-30253f43092b5
856783amitriptyline HCl 10 MG Oral TabletPSN5a5a4040-5395-54ac-e053-2991aa0aa4ab4
856783amitriptyline HCl 10 MG Oral TabletPSN58ff9a82-5de6-a1b0-e053-2991aa0a84ba4
856783amitriptyline hydrochloride 10 MG Oral TabletSCD5a5a4040-5395-54ac-e053-2991aa0aa4ab4
856783amitriptyline hydrochloride 10 MG Oral TabletSCD58ff9a82-5de6-a1b0-e053-2991aa0a84ba4
856783amitriptyline HCl 10 MG Oral TabletPSNe3afe026-7072-0a7d-e053-2995a90a52d42
856783amitriptyline HCl 10 MG Oral TabletPSN90156099-9a97-9bd8-e053-2a95a90abca02
856783amitriptyline HCl 10 MG Oral TabletPSN4b7fcf0c-6d2c-20b2-e054-00144ff8d46c2
856783amitriptyline HCl 10 MG Oral TabletPSN9004e8d9-8488-7afd-e053-2995a90adfc22
856834amitriptyline HCl 25 MG Oral TabletPSN4b7fcf0c-6d2c-20b2-e054-00144ff8d46c2
856783amitriptyline hydrochloride 10 MG Oral TabletSCD90156099-9a97-9bd8-e053-2a95a90abca02
856783amitriptyline hydrochloride 10 MG Oral TabletSCD9004e8d9-8488-7afd-e053-2995a90adfc22
856783amitriptyline hydrochloride 10 MG Oral TabletSCD4b7fcf0c-6d2c-20b2-e054-00144ff8d46c2
856783amitriptyline hydrochloride 10 MG Oral TabletSCDe3afe026-7072-0a7d-e053-2995a90a52d42
856834amitriptyline hydrochloride 25 MG Oral TabletSCD4b7fcf0c-6d2c-20b2-e054-00144ff8d46c2
856783amitriptyline HCl 10 MG Oral TabletPSN441c4b38-145a-4a05-bca8-af9744cb28621
856783amitriptyline hydrochloride 10 MG Oral TabletSCD441c4b38-145a-4a05-bca8-af9744cb28621

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16729-171-0116729017101100 TABLET, FILM COATED in 1 BOTTLE (16729-171-01) 2014-12-180000-00-00NoNoCurrent
16729-171-101672901711030 in 1 BOTTLEHistorical
16729-171-17167290171171000 TABLET, FILM COATED in 1 BOTTLE (16729-171-17) 2014-12-050000-00-00NoNoCurrent