AMITRIPTYLINE HYDROCHLORIDE

Product NDC
53217-273
11-digit product format
532170273
Labeler code
53217
Product ID
53217-273_fa309fa7-1a52-4c72-8bfd-0700712371f9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
AMITRIPTYLINE HYDROCHLORIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA202446
Marketing category
ANDA
Marketing start
2014-12-05
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
2019-12-31
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
53217-273-30AMITRIPTYLINE HYDROCHLORIDE30 in 1 BOTTLETABLET, FILM COATED301
53217-273-60AMITRIPTYLINE HYDROCHLORIDE60 in 1 BOTTLETABLET, FILM COATED601
53217-273-90AMITRIPTYLINE HYDROCHLORIDE90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53217-273AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 3 package rows20170420_441c4b38-145a-4a05-bca8-af9744cb2862.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856783amitriptyline HCl 10 MG Oral TabletPSN441c4b38-145a-4a05-bca8-af9744cb28621
856783amitriptyline hydrochloride 10 MG Oral TabletSCD441c4b38-145a-4a05-bca8-af9744cb28621

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53217-273-305321702733030 in 1 BOTTLEHistorical
53217-273-605321702736060 in 1 BOTTLEHistorical
53217-273-905321702739090 in 1 BOTTLEHistorical