Amitriptyline Hydrochloride

Product NDC
60687-444
11-digit product format
606870444
Labeler code
60687
Product ID
60687-444_44706732-5523-8018-e063-6294a90a9cc7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amitriptyline Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
American Health Packaging
Application
ANDA210086
Marketing category
ANDA
Marketing start
2019-08-12
Substance
AMITRIPTYLINE HYDROCHLORIDE
Active strength
50 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 HYDROCHLORIDE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii26LUD4JO9K
Rxcui856834, 856845

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
60687-444-01Amitriptyline Hydrochloride100 in 1 BOX, UNIT-DOSETABLET, FILM COATED1007
60687-444-11Amitriptyline Hydrochloride1 in 1 BLISTER PACKTABLET, FILM COATED17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-444-01EA - Each60687-444147936dd-406f-48b0-8782-ade26c387f2412019-08-06
60687-444-11EA - Each60687-444da595804-68ee-4126-b4bd-8f35110ce71012019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-444AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]6Current NDC, Legacy NDC, 2 package rows20240926_98cc0bf3-ae5b-47cc-992f-9157fed7c3f4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856834amitriptyline HCl 25 MG Oral TabletPSN98cc0bf3-ae5b-47cc-992f-9157fed7c3f47
856845amitriptyline HCl 50 MG Oral TabletPSN98cc0bf3-ae5b-47cc-992f-9157fed7c3f47
856834amitriptyline hydrochloride 25 MG Oral TabletSCD98cc0bf3-ae5b-47cc-992f-9157fed7c3f47
856845amitriptyline hydrochloride 50 MG Oral TabletSCD98cc0bf3-ae5b-47cc-992f-9157fed7c3f47

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60687-444-0160687044401100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-444-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-444-11) 100 blister pack2019-08-120000-00-00NoNoCurrent
60687-444-11606870444111 in 1 BLISTER PACKHistorical