FDA.reportPublic FDA data

Amitriptyline Hydrochloride

Product NDC
70756-203
11-digit product format
707560203
Labeler code
70756
Product ID
70756-203_2595d2ab-fd5d-462c-82d4-656d20aa9415
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amitriptyline Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Lifestar Pharma LLC
Application
ANDA213999
Marketing category
ANDA
Marketing start
2021-02-23
Substance
AMITRIPTYLINE HYDROCHLORIDE
Active strength
50 mg/1
Pharmacologic classes
Tricyclic Antidepressant [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Amitriptyline Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMITRIPTYLINE HYDROCHLORIDE50 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
70756-203-11Amitriptyline Hydrochloride100 in 1 BOTTLETABLET, FILM COATED1009
70756-203-12Amitriptyline Hydrochloride1000 in 1 BOTTLETABLET, FILM COATED10009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70756-203-11EA - Each70756-20342b1ec8e-27a4-4c1f-a16b-554eb63fb34112021-04-08
70756-203-12EA - Each70756-203bde136ac-c3ab-447a-b7b2-26b417b4684112021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70756-203AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [LIFESTAR PHARMA LLC]7Current NDC, Legacy NDC, 2 package rows20250410_67e31675-1da2-4acf-84ac-77522b02f0b9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856783amitriptyline HCl 10 MG Oral TabletPSN67e31675-1da2-4acf-84ac-77522b02f0b99
856762amitriptyline HCl 100 MG Oral TabletPSN67e31675-1da2-4acf-84ac-77522b02f0b99
856773amitriptyline HCl 150 MG Oral TabletPSN67e31675-1da2-4acf-84ac-77522b02f0b99
856834amitriptyline HCl 25 MG Oral TabletPSN67e31675-1da2-4acf-84ac-77522b02f0b99
856845amitriptyline HCl 50 MG Oral TabletPSN67e31675-1da2-4acf-84ac-77522b02f0b99
856853amitriptyline HCl 75 MG Oral TabletPSN67e31675-1da2-4acf-84ac-77522b02f0b99
856783amitriptyline hydrochloride 10 MG Oral TabletSCD67e31675-1da2-4acf-84ac-77522b02f0b99
856762amitriptyline hydrochloride 100 MG Oral TabletSCD67e31675-1da2-4acf-84ac-77522b02f0b99
856773amitriptyline hydrochloride 150 MG Oral TabletSCD67e31675-1da2-4acf-84ac-77522b02f0b99
856834amitriptyline hydrochloride 25 MG Oral TabletSCD67e31675-1da2-4acf-84ac-77522b02f0b99
856845amitriptyline hydrochloride 50 MG Oral TabletSCD67e31675-1da2-4acf-84ac-77522b02f0b99
856853amitriptyline hydrochloride 75 MG Oral TabletSCD67e31675-1da2-4acf-84ac-77522b02f0b99
856845amitriptyline HCl 50 MG Oral TabletPSNf8236cd1-1b60-4a66-e053-6294a90afeb04
856845amitriptyline hydrochloride 50 MG Oral TabletSCDf8236cd1-1b60-4a66-e053-6294a90afeb04

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70756-203-1170756020311100 TABLET, FILM COATED in 1 BOTTLE (70756-203-11) 2021-02-230000-00-00NoNoCurrent
70756-203-12707560203121000 TABLET, FILM COATED in 1 BOTTLE (70756-203-12) 2021-02-230000-00-00NoNoCurrent