Amitriptyline Hydrochloride

Product NDC
70756-206
11-digit product format
707560206
Labeler code
70756
Product ID
70756-206_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
150 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 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
70756-206-11Amitriptyline Hydrochloride100 in 1 BOTTLETABLET, FILM COATED1009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70756-206-11EA - Each70756-206ea4a2f86-c32d-40cd-97d9-532b01f1927c12021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70756-206AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [LIFESTAR PHARMA LLC]7Current NDC, Legacy NDC, 1 package rows20250410_67e31675-1da2-4acf-84ac-77522b02f0b9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856773amitriptyline HCl 150 MG Oral TabletPSN9f9d6495-47ff-4dcf-9643-ebd5cd7499cb101
856773amitriptyline hydrochloride 150 MG Oral TabletSCD9f9d6495-47ff-4dcf-9643-ebd5cd7499cb101
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
856773amitriptyline HCl 150 MG Oral TabletPSN23ab2afe-06c1-fa61-e063-6394a90abcf81
856773amitriptyline hydrochloride 150 MG Oral TabletSCD23ab2afe-06c1-fa61-e063-6394a90abcf81

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70756-206-1170756020611100 TABLET, FILM COATED in 1 BOTTLE (70756-206-11) 2021-02-230000-00-00NoNoCurrent