Amitriptyline Hydrochloride

Product NDC
50090-3986
11-digit product format
500903986
Labeler code
50090
Product ID
50090-3986_243c8d9b-2264-457f-8be5-0dca9e8c35f0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amitriptyline Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA210086
Marketing category
ANDA
Marketing start
2017-12-26
Marketing end
0000-00-00
Substance
AMITRIPTYLINE HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Tricyclic Antidepressant [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3986-0Amitriptyline Hydrochloride30 in 1 BOTTLETABLET, FILM COATED305
50090-3986-1Amitriptyline Hydrochloride100 in 1 BOTTLE, PLASTICTABLET, FILM COATED1005
50090-3986-6Amitriptyline Hydrochloride90 in 1 BOTTLE, PLASTICTABLET, FILM COATED905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3986-0EA - Each50090-3986418d9a62-3a05-4941-b3f4-9fc057ab819a12021-12-08
50090-3986-1EA - Each50090-3986aa33cdc6-1040-4345-947e-d8e5d8e9754b12021-12-08
50090-3986-6EA - Each50090-3986743aac96-c6cd-4f17-a37e-637c8878160312021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3986AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]5Legacy NDC, 3 package rows20210417_6e32332e-144b-4c15-8fe8-ffff075357aa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856783amitriptyline HCl 10 MG Oral TabletPSN6e32332e-144b-4c15-8fe8-ffff075357aa5
856783amitriptyline hydrochloride 10 MG Oral TabletSCD6e32332e-144b-4c15-8fe8-ffff075357aa5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-3986-05009039860030 TABLET, FILM COATED in 1 BOTTLE (50090-3986-0) 2018-12-170000-00-00NoNoCurrent
50090-3986-150090398601100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-3986-1) 2017-12-260000-00-00NoNoCurrent
50090-3986-65009039860690 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-3986-6) 2017-12-260000-00-00NoNoCurrent