Amitriptyline Hydrochloride

Product NDC
67046-1671
11-digit product format
670461671
Labeler code
67046
Product ID
67046-1671_5070f035-3456-f66e-e063-6294a90a5d83
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amitriptyline Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Coupler LLC
Application
ANDA210086
Marketing category
ANDA
Marketing start
2026-04-27
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
Rxcui856773

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
67046-1671-3Amitriptyline Hydrochloride30 in 1 BLISTER PACKTABLET, FILM COATED301

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856773amitriptyline HCl 150 MG Oral TabletPSN5070fa18-ecc9-de14-e063-6394a90a372e1
856773amitriptyline hydrochloride 150 MG Oral TabletSCD5070fa18-ecc9-de14-e063-6394a90a372e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
67046-1671-36704616710330 TABLET, FILM COATED in 1 BLISTER PACK (67046-1671-3) 2026-04-27NoNoHistorical