AMITRIPTYLINE HYDROCHLORIDE

Product NDC
61919-076
11-digit product format
619190076
Labeler code
61919
Product ID
61919-076_b946a11a-f380-706f-e053-2a95a90aa4be
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
AMITRIPTYLINE HYDROCHLORIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
DIRECT RX
Application
ANDA202446
Marketing category
ANDA
Marketing start
2017-02-16
Marketing end
0000-00-00
Substance
AMITRIPTYLINE HYDROCHLORIDE
Active strength
50 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
61919-076-60AMITRIPTYLINE HYDROCHLORIDE60 in 1 BOTTLETABLET, FILM COATED604
61919-076-90AMITRIPTYLINE HYDROCHLORIDE90 in 1 BOTTLETABLET, FILM COATED904
61919-076-30AMITRIPTYLINE HYDROCHLORIDE30 in 1 BOTTLETABLET, FILM COATED302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-076-30EA - Each61919-0761e3340e5-0f08-47aa-99dc-1e41811a093112019-08-06
61919-076-60EA - Each61919-076a888cbf4-34d5-4f9f-b6ae-6ca2e4e1b8f912019-08-06
61919-076-90EA - Each61919-0769093924a-5f64-4972-97af-c332828dea8812021-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-076AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX]4Legacy NDC, 2 package rows20230411_48a65c4c-bfee-1584-e054-00144ff88e88.zip
61919-076AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [DIRECT_RX]2Legacy NDC, 1 package rows20200118_8ee78d77-b5d0-1e6a-e053-2995a90ac697.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856845amitriptyline HCl 50 MG Oral TabletPSN48a65c4c-bfee-1584-e054-00144ff88e884
856845amitriptyline hydrochloride 50 MG Oral TabletSCD48a65c4c-bfee-1584-e054-00144ff88e884
856845amitriptyline HCl 50 MG Oral TabletPSN8ee78d77-b5d0-1e6a-e053-2995a90ac6972
856845amitriptyline hydrochloride 50 MG Oral TabletSCD8ee78d77-b5d0-1e6a-e053-2995a90ac6972

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61919-076-306191900763030 TABLET, FILM COATED in 1 BOTTLE (61919-076-30) 2019-07-300000-00-00NoNoCurrent
61919-076-606191900766060 TABLET, FILM COATED in 1 BOTTLE (61919-076-60) 2017-02-160000-00-00NoNoCurrent
61919-076-906191900769090 TABLET, FILM COATED in 1 BOTTLE (61919-076-90) 2017-02-160000-00-00NoNoCurrent