AMITRIPTYLINE HYDROCHLORIDE

Product NDC
69158-002
11-digit product format
691580002
Labeler code
69158
Product ID
69158-002_3171e373-6375-4467-b3f0-872e9221a773
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
AMITRIPTYLINE HYDROCHLORIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
GLENVIEW PHARMA INC.
Application
ANDA085968
Marketing category
ANDA
Marketing start
1977-11-29
Marketing end
0000-00-00
Substance
AMITRIPTYLINE HYDROCHLORIDE
Active strength
50 mg/1
Pharmacologic classes
Tricyclic Antidepressant [EPC]
NDC exclude flag
E
Listing certified through
2018-12-31
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69158-002-002020-01-31C16284748780-19d75b9d0-f81d-f424-e053-dadaa90a57ceAMITRIPTYLINE HYDROCHLORIDE TABLETS, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69158-002-00AMITRIPTYLINE HYDROCHLORIDE100 in 1 BOTTLETABLET, FILM COATED1004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69158-002AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [GLENVIEW PHARMA INC.]4Legacy NDC, 1 package rows20140910_94e984da-3b08-406f-8c10-e78844fca1ff.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856783amitriptyline HCl 10 MG Oral TabletPSN94e984da-3b08-406f-8c10-e78844fca1ff4
856834amitriptyline HCl 25 MG Oral TabletPSN94e984da-3b08-406f-8c10-e78844fca1ff4
856845amitriptyline HCl 50 MG Oral TabletPSN94e984da-3b08-406f-8c10-e78844fca1ff4
856783amitriptyline hydrochloride 10 MG Oral TabletSCD94e984da-3b08-406f-8c10-e78844fca1ff4
856834amitriptyline hydrochloride 25 MG Oral TabletSCD94e984da-3b08-406f-8c10-e78844fca1ff4
856845amitriptyline hydrochloride 50 MG Oral TabletSCD94e984da-3b08-406f-8c10-e78844fca1ff4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
69158-002-0069158000200100 in 1 BOTTLEHistorical