FDA.reportPublic FDA data

Amitriptyline Hydrochloride

Product NDC
51655-084
11-digit product format
516550084
Labeler code
51655
Product ID
51655-084_4ab6d63f-7efb-0930-e063-6294a90af17e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amitriptyline Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA213999
Marketing category
ANDA
Marketing start
2023-03-06
Substance
AMITRIPTYLINE HYDROCHLORIDE
Active strength
10 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 HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii26LUD4JO9K
Rxcui856783

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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51655-084-262026-01-29C16284748780-149896155-a27c-586f-e063-e6dba90add90Amitriptyline Hydrochloride Tablets, USP
51655-084-522026-01-29C16284748780-149896155-a27c-586f-e063-e6dba90add90Amitriptyline Hydrochloride Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51655-084-26Amitriptyline Hydrochloride90 in 1 BOTTLE, PLASTICTABLET, FILM COATED905
51655-084-52Amitriptyline Hydrochloride30 in 1 BOTTLE, PLASTICTABLET, FILM COATED305

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-084AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS, LLC]1Current NDC, 2 package rows20230404_f67d6f73-88d7-2031-e053-2995a90a3b09.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856783amitriptyline HCl 10 MG Oral TabletPSNf67d6f73-88d7-2031-e053-2995a90a3b095
856783amitriptyline hydrochloride 10 MG Oral TabletSCDf67d6f73-88d7-2031-e053-2995a90a3b095

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
51655-084-265165500842690 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-084-26) 2023-03-06NoNoCurrent
51655-084-525165500845230 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-084-52) 2023-03-06NoNoCurrent