AMITRIPTYLINE HYDROCHLORIDE

Product NDC
53217-269
11-digit product format
532170269
Labeler code
53217
Product ID
53217-269_dcabe216-0131-4b2c-82a7-22de2ce0aeaa
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
25 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
53217-269-30AMITRIPTYLINE HYDROCHLORIDE30 in 1 BOTTLETABLET, FILM COATED301
53217-269-60AMITRIPTYLINE HYDROCHLORIDE60 in 1 BOTTLETABLET, FILM COATED601
53217-269-90AMITRIPTYLINE HYDROCHLORIDE90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53217-269-30EA - Each53217-2696a2238fe-f21e-48ca-9e94-cc66382c528012017-05-03
53217-269-60EA - Each53217-269dda10684-3c0d-4341-8dfb-8fd186fdaac712017-05-04
53217-269-90EA - Each53217-26964e5ab26-3dd3-4505-8786-cfe468338d5b12017-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53217-269AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 3 package rows20170412_b29a161a-be0c-40a8-b68e-0071f58fcad0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856834amitriptyline HCl 25 MG Oral TabletPSNb29a161a-be0c-40a8-b68e-0071f58fcad01
856834amitriptyline hydrochloride 25 MG Oral TabletSCDb29a161a-be0c-40a8-b68e-0071f58fcad01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53217-269-305321702693030 in 1 BOTTLEHistorical
53217-269-605321702696060 in 1 BOTTLEHistorical
53217-269-905321702699090 in 1 BOTTLEHistorical