Amitriptyline Hydrochloride

Product NDC
52959-514
11-digit product format
529590514
Labeler code
52959
Product ID
52959-514_a90b16ab-0c90-4e42-a281-7989f2158ebe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amitriptyline Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
H.J. Harkins Company, Inc.
Application
ANDA085968
Marketing category
ANDA
Marketing start
1977-11-29
Marketing end
0000-00-00
Substance
AMITRIPTYLINE HYDROCHLORIDE
Active strength
50 mg/1
Pharmacologic classes
Tricyclic Antidepressant [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52959-514-00EA - Each52959-5144a887289-1837-40e0-a9f8-4f6947c2ac3512012-07-24
52959-514-01EA - Each52959-5145d9a5ac4-8f45-46f2-a381-58c8317f1b7e12012-07-24
52959-514-10EA - Each52959-514c36f9f95-af4d-4fc1-905d-7f91dd0d38c812012-07-24
52959-514-20EA - Each52959-514dc2132bc-db19-470b-97e4-7b96321c56a712012-07-24
52959-514-21EA - Each52959-514497b9a0c-1048-4c01-ba4b-9ebeba2ecaca12012-07-24
52959-514-30EA - Each52959-5147d27c487-7a24-463a-9331-5f9eacd57a3712012-07-24
52959-514-60EA - Each52959-5148efd4907-59fc-477b-bc2b-ee3113ef7b0d12012-07-24
52959-514-90EA - Each52959-5144bb7556b-7db3-4e1f-b0ff-5866e86a7adf12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMITRIPTYLINE HYDROCHLORIDEACTIVE INGREDIENT26LUD4JO9KAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1
AMITRIPTYLINEACTIVE MOIETY1806D8D52KAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1