FDA.reportPublic FDA data

Amitriptyline Hydrochloride

Product NDC
51407-794
11-digit product format
514070794
Labeler code
51407
Product ID
51407-794_3d475953-ddd4-2ece-e063-6294a90a1005
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amitriptyline Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA089399
Marketing category
ANDA
Marketing start
1987-07-14
Substance
AMITRIPTYLINE HYDROCHLORIDE
Active strength
25 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 HYDROCHLORIDE25 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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
6f1277d7-db3a-63fa-be84-d390d1482706Product name120140508
aa9828b2-adf8-0dd3-9f6c-b68f39e467c1Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51407-794-01Amitriptyline Hydrochloride100 in 1 BOTTLE, PLASTICTABLET, FILM COATED1004
51407-794-10Amitriptyline Hydrochloride1000 in 1 BOTTLE, PLASTICTABLET, FILM COATED10004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51407-794-01EA - Each51407-7942b230b4f-3221-443b-8265-e871fb86b19d12023-10-16
51407-794-10EA - Each51407-794fc9ae9d5-49f2-421f-890c-62e9ec67ecd712023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51407-794AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]2Current NDC, 2 package rows20231104_04e1c5f8-de7e-8ce7-e063-6394a90acc57.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856783amitriptyline HCl 10 MG Oral TabletPSN04e1c5f8-de7e-8ce7-e063-6394a90acc574
856762amitriptyline HCl 100 MG Oral TabletPSN04e1c5f8-de7e-8ce7-e063-6394a90acc574
856773amitriptyline HCl 150 MG Oral TabletPSN04e1c5f8-de7e-8ce7-e063-6394a90acc574
856834amitriptyline HCl 25 MG Oral TabletPSN04e1c5f8-de7e-8ce7-e063-6394a90acc574
856845amitriptyline HCl 50 MG Oral TabletPSN04e1c5f8-de7e-8ce7-e063-6394a90acc574
856853amitriptyline HCl 75 MG Oral TabletPSN04e1c5f8-de7e-8ce7-e063-6394a90acc574
856783amitriptyline hydrochloride 10 MG Oral TabletSCD04e1c5f8-de7e-8ce7-e063-6394a90acc574
856762amitriptyline hydrochloride 100 MG Oral TabletSCD04e1c5f8-de7e-8ce7-e063-6394a90acc574
856773amitriptyline hydrochloride 150 MG Oral TabletSCD04e1c5f8-de7e-8ce7-e063-6394a90acc574
856834amitriptyline hydrochloride 25 MG Oral TabletSCD04e1c5f8-de7e-8ce7-e063-6394a90acc574
856845amitriptyline hydrochloride 50 MG Oral TabletSCD04e1c5f8-de7e-8ce7-e063-6394a90acc574
856853amitriptyline hydrochloride 75 MG Oral TabletSCD04e1c5f8-de7e-8ce7-e063-6394a90acc574
856783amitriptyline HCl 10 MG Oral TabletPSN25832051-837b-4682-8548-5ab9a1b7cdac1
856834amitriptyline HCl 25 MG Oral TabletPSN25832051-837b-4682-8548-5ab9a1b7cdac1
856845amitriptyline HCl 50 MG Oral TabletPSN25832051-837b-4682-8548-5ab9a1b7cdac1
856783amitriptyline hydrochloride 10 MG Oral TabletSCD25832051-837b-4682-8548-5ab9a1b7cdac1
856834amitriptyline hydrochloride 25 MG Oral TabletSCD25832051-837b-4682-8548-5ab9a1b7cdac1
856845amitriptyline hydrochloride 50 MG Oral TabletSCD25832051-837b-4682-8548-5ab9a1b7cdac1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
51407-794-0151407079401100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51407-794-01) 2023-09-01NoNoHistorical
51407-794-10514070794101000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51407-794-10) 2023-09-01NoNoHistorical