FDA.reportPublic FDA data

Amitriptyline Hydrochloride

Product NDC
80425-0285
11-digit product format
804250285
Labeler code
80425
Product ID
80425-0285_2a9b9724-0256-e829-e063-6394a90a1c07
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amitriptyline Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Advanced Rx Pharmacy of Tennessee, LLC
Application
ANDA214548
Marketing category
ANDA
Marketing start
2023-03-22
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
Rxcui856834

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
80425-0285-1Amitriptyline Hydrochloride30 in 1 BOTTLETABLET, FILM COATED302
80425-0285-2Amitriptyline Hydrochloride60 in 1 BOTTLETABLET, FILM COATED602
80425-0285-3Amitriptyline Hydrochloride90 in 1 BOTTLETABLET, FILM COATED902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0285-1EA - Each80425-02858ac05c3c-7f53-4840-8b14-ed9eccf2037812023-04-07
80425-0285-2EA - Each80425-028545e21b2d-7df6-4726-bcde-f24762b34bf512023-06-06
80425-0285-3EA - Each80425-0285a3757cef-b1c8-4e1c-b8a8-46487d0f84fe12023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0285AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [ADVANCED RX PHARMACY OF TENNESSEE, LLC]2Current NDC, 3 package rows20250102_f98d25a7-6b47-38a9-e053-6394a90a541d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856834amitriptyline HCl 25 MG Oral TabletPSNf98d25a7-6b47-38a9-e053-6394a90a541d2
856834amitriptyline hydrochloride 25 MG Oral TabletSCDf98d25a7-6b47-38a9-e053-6394a90a541d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
80425-0285-18042502850130 TABLET, FILM COATED in 1 BOTTLE (80425-0285-1) 2023-03-22NoNoHistorical
80425-0285-28042502850260 TABLET, FILM COATED in 1 BOTTLE (80425-0285-2) 2023-03-22NoNoHistorical
80425-0285-38042502850390 TABLET, FILM COATED in 1 BOTTLE (80425-0285-3) 2023-03-22NoNoHistorical