FDA.reportPublic FDA data

Amitriptyline Hydrochloride

Product NDC
16571-109
11-digit product format
165710109
Labeler code
16571
Product ID
16571-109_a83b8840-dd78-46f1-b952-893c30bf5bf9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amitriptyline Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA217411
Marketing category
ANDA
Marketing start
2023-06-10
Substance
AMITRIPTYLINE HYDROCHLORIDE
Active strength
100 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 HYDROCHLORIDE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii26LUD4JO9K
Rxcui856762, 856773, 856783, 856834, 856845, 856853

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e5006e90-7f2e-4341-bcdb-f83027a8fc39Product name620240611
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
6f1277d7-db3a-63fa-be84-d390d1482706Product name120140508
aa9828b2-adf8-0dd3-9f6c-b68f39e467c1Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16571-109-01Amitriptyline Hydrochloride100 in 1 BOTTLETABLET1002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16571-109-01EA - Each16571-10952867b3b-0c16-450a-831a-515002ee843112023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16571-109AMITRIPTYLINE HYDROCHLORIDE TABLET [RISING PHARMA HOLDINGS, INC.]2Current NDC, 1 package rows20250523_a219a68e-7ce5-4e9d-a0de-ec76960040f6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856762amitriptyline HCl 100 MG Oral TabletPSNbb02d7b8-8f1a-4cc4-b763-223e6894f02c3
856762amitriptyline hydrochloride 100 MG Oral TabletSCDbb02d7b8-8f1a-4cc4-b763-223e6894f02c3
856783amitriptyline HCl 10 MG Oral TabletPSNa219a68e-7ce5-4e9d-a0de-ec76960040f62
856762amitriptyline HCl 100 MG Oral TabletPSN19b0c015-c07f-63b7-e063-6394a90a60602
856762amitriptyline HCl 100 MG Oral TabletPSNa219a68e-7ce5-4e9d-a0de-ec76960040f62
856773amitriptyline HCl 150 MG Oral TabletPSNa219a68e-7ce5-4e9d-a0de-ec76960040f62
856834amitriptyline HCl 25 MG Oral TabletPSN19b0c015-c07f-63b7-e063-6394a90a60602
856834amitriptyline HCl 25 MG Oral TabletPSNa219a68e-7ce5-4e9d-a0de-ec76960040f62
856845amitriptyline HCl 50 MG Oral TabletPSNa219a68e-7ce5-4e9d-a0de-ec76960040f62
856853amitriptyline HCl 75 MG Oral TabletPSNa219a68e-7ce5-4e9d-a0de-ec76960040f62
856783amitriptyline hydrochloride 10 MG Oral TabletSCDa219a68e-7ce5-4e9d-a0de-ec76960040f62
856762amitriptyline hydrochloride 100 MG Oral TabletSCDa219a68e-7ce5-4e9d-a0de-ec76960040f62
856762amitriptyline hydrochloride 100 MG Oral TabletSCD19b0c015-c07f-63b7-e063-6394a90a60602
856773amitriptyline hydrochloride 150 MG Oral TabletSCDa219a68e-7ce5-4e9d-a0de-ec76960040f62
856834amitriptyline hydrochloride 25 MG Oral TabletSCD19b0c015-c07f-63b7-e063-6394a90a60602
856834amitriptyline hydrochloride 25 MG Oral TabletSCDa219a68e-7ce5-4e9d-a0de-ec76960040f62
856845amitriptyline hydrochloride 50 MG Oral TabletSCDa219a68e-7ce5-4e9d-a0de-ec76960040f62
856853amitriptyline hydrochloride 75 MG Oral TabletSCDa219a68e-7ce5-4e9d-a0de-ec76960040f62
856762amitriptyline HCl 100 MG Oral TabletPSNc707a873-6b67-478f-aa3c-d206a59cbe6d1
856762amitriptyline HCl 100 MG Oral TabletPSN15c2afe3-3309-4abc-87d1-f3eab8d89b201
856762amitriptyline HCl 100 MG Oral TabletPSN85574987-8d31-4bd0-b829-bb154ef212f51
856762amitriptyline HCl 100 MG Oral TabletPSN485b87c3-2a51-133b-e063-6294a90a95c31
856762amitriptyline HCl 100 MG Oral TabletPSN227affe9-36ee-2423-e063-6394a90a58f61
856762amitriptyline hydrochloride 100 MG Oral TabletSCD85574987-8d31-4bd0-b829-bb154ef212f51
856762amitriptyline hydrochloride 100 MG Oral TabletSCD485b87c3-2a51-133b-e063-6294a90a95c31
856762amitriptyline hydrochloride 100 MG Oral TabletSCD227affe9-36ee-2423-e063-6394a90a58f61
856762amitriptyline hydrochloride 100 MG Oral TabletSCDc707a873-6b67-478f-aa3c-d206a59cbe6d1
856762amitriptyline hydrochloride 100 MG Oral TabletSCD15c2afe3-3309-4abc-87d1-f3eab8d89b201

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
16571-109-0116571010901100 TABLET in 1 BOTTLE (16571-109-01) 100 tablet2023-06-10NoNoCurrent