FDA.reportPublic FDA data

Amitriptyline Hydrochloride

Product NDC
16714-258
11-digit product format
167140258
Labeler code
16714
Product ID
16714-258_f089e8f9-aed0-4f80-812d-35a969447345
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amitriptyline Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Northstar Rx LLC.
Application
ANDA210086
Marketing category
ANDA
Marketing start
2021-08-25
Substance
AMITRIPTYLINE HYDROCHLORIDE
Active strength
25 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 HYDROCHLORIDE25 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
6f1277d7-db3a-63fa-be84-d390d1482706Product name120140508
aa9828b2-adf8-0dd3-9f6c-b68f39e467c1Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16714-258-01Amitriptyline Hydrochloride100 in 1 BOTTLETABLET, FILM COATED1004
16714-258-02Amitriptyline Hydrochloride1000 in 1 BOTTLETABLET, FILM COATED10004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-258-01EA - Each16714-2580213e20b-e262-47da-be47-386c9da1613c12021-11-09
16714-258-02EA - Each16714-258b0e4c507-db1f-40ae-bd46-eea8a63d4b8f12021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16714-258AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [NORTHSTAR RX LLC.]3Current NDC, Legacy NDC, 2 package rows20250418_8ed28f42-e41a-45ca-a86f-849ebeb6ab80.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856783amitriptyline HCl 10 MG Oral TabletPSN8ed28f42-e41a-45ca-a86f-849ebeb6ab804
856762amitriptyline HCl 100 MG Oral TabletPSN8ed28f42-e41a-45ca-a86f-849ebeb6ab804
856773amitriptyline HCl 150 MG Oral TabletPSN8ed28f42-e41a-45ca-a86f-849ebeb6ab804
856834amitriptyline HCl 25 MG Oral TabletPSN8ed28f42-e41a-45ca-a86f-849ebeb6ab804
856845amitriptyline HCl 50 MG Oral TabletPSN8ed28f42-e41a-45ca-a86f-849ebeb6ab804
856853amitriptyline HCl 75 MG Oral TabletPSN8ed28f42-e41a-45ca-a86f-849ebeb6ab804
856783amitriptyline hydrochloride 10 MG Oral TabletSCD8ed28f42-e41a-45ca-a86f-849ebeb6ab804
856762amitriptyline hydrochloride 100 MG Oral TabletSCD8ed28f42-e41a-45ca-a86f-849ebeb6ab804
856773amitriptyline hydrochloride 150 MG Oral TabletSCD8ed28f42-e41a-45ca-a86f-849ebeb6ab804
856834amitriptyline hydrochloride 25 MG Oral TabletSCD8ed28f42-e41a-45ca-a86f-849ebeb6ab804
856845amitriptyline hydrochloride 50 MG Oral TabletSCD8ed28f42-e41a-45ca-a86f-849ebeb6ab804
856853amitriptyline hydrochloride 75 MG Oral TabletSCD8ed28f42-e41a-45ca-a86f-849ebeb6ab804
856834amitriptyline HCl 25 MG Oral TabletPSNf410257d-b3be-31d6-e053-2995a90a32741
856834amitriptyline HCl 25 MG Oral TabletPSN5e8c8c5f-4964-4642-ad4b-69a75b2c8a021
856834amitriptyline HCl 25 MG Oral TabletPSNd22879c5-925a-42e0-9d48-55a4221929831
856834amitriptyline hydrochloride 25 MG Oral TabletSCDd22879c5-925a-42e0-9d48-55a4221929831
856834amitriptyline hydrochloride 25 MG Oral TabletSCDf410257d-b3be-31d6-e053-2995a90a32741
856834amitriptyline hydrochloride 25 MG Oral TabletSCD5e8c8c5f-4964-4642-ad4b-69a75b2c8a021

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16714-258-0116714025801100 TABLET, FILM COATED in 1 BOTTLE (16714-258-01) 2021-08-250000-00-00NoNoCurrent
16714-258-02167140258021000 TABLET, FILM COATED in 1 BOTTLE (16714-258-02) 2021-08-250000-00-00NoNoCurrent