Amitriptyline Hydrochloride

Product NDC
72888-072
11-digit product format
728880072
Labeler code
72888
Product ID
72888-072_451e8ad6-a78e-429b-e063-6394a90a2bdb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amitriptyline Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Advagen Pharma Ltd
Application
ANDA215376
Marketing category
ANDA
Marketing start
2023-05-01
Substance
AMITRIPTYLINE HYDROCHLORIDE
Active strength
150 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 HYDROCHLORIDE150 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
72888-072-01Amitriptyline Hydrochloride100 in 1 BOTTLETABLET, FILM COATED1004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72888-072AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [ADVAGEN PHARMA LTD]2Current NDC, 1 package rows20230706_651bd090-a420-4dd8-89b0-4cb766c144c2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856783amitriptyline HCl 10 MG Oral TabletPSN651bd090-a420-4dd8-89b0-4cb766c144c24
856762amitriptyline HCl 100 MG Oral TabletPSN651bd090-a420-4dd8-89b0-4cb766c144c24
856773amitriptyline HCl 150 MG Oral TabletPSN651bd090-a420-4dd8-89b0-4cb766c144c24
856834amitriptyline HCl 25 MG Oral TabletPSN651bd090-a420-4dd8-89b0-4cb766c144c24
856845amitriptyline HCl 50 MG Oral TabletPSN651bd090-a420-4dd8-89b0-4cb766c144c24
856853amitriptyline HCl 75 MG Oral TabletPSN651bd090-a420-4dd8-89b0-4cb766c144c24
856783amitriptyline hydrochloride 10 MG Oral TabletSCD651bd090-a420-4dd8-89b0-4cb766c144c24
856762amitriptyline hydrochloride 100 MG Oral TabletSCD651bd090-a420-4dd8-89b0-4cb766c144c24
856773amitriptyline hydrochloride 150 MG Oral TabletSCD651bd090-a420-4dd8-89b0-4cb766c144c24
856834amitriptyline hydrochloride 25 MG Oral TabletSCD651bd090-a420-4dd8-89b0-4cb766c144c24
856845amitriptyline hydrochloride 50 MG Oral TabletSCD651bd090-a420-4dd8-89b0-4cb766c144c24
856853amitriptyline hydrochloride 75 MG Oral TabletSCD651bd090-a420-4dd8-89b0-4cb766c144c24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72888-072-0172888007201100 TABLET, FILM COATED in 1 BOTTLE (72888-072-01) 2023-05-01NoNoCurrent