Amitriptyline Hydrochloride

Product NDC
61919-289
11-digit product format
619190289
Labeler code
61919
Product ID
61919-289_ea4e4f18-ea96-2171-e053-2995a90ac2d2
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
2019-07-24
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
2023-12-31
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
61919-289-302025-01-30C16284748780-12cef2736-5c8c-d83d-e063-dadaa90ab31fAMITRIPTYLINE HYDROCHLORIDE
61919-289-602025-01-30C16284748780-12cef2736-a199-d83d-e063-dadaa90ab31fAMITRIPTYLINE HYDROCHLORIDE
61919-289-902025-01-30C16284748780-12cef2736-6fb7-d83d-e063-dadaa90ab31fAMITRIPTYLINE HYDROCHLORIDE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-289-60Amitriptyline Hydrochloride60 in 1 BOTTLETABLET, FILM COATED604
61919-289-30Amitriptyline Hydrochloride30 in 1 BOTTLETABLET, FILM COATED302
61919-289-90Amitriptyline Hydrochloride90 in 1 BOTTLETABLET, FILM COATED902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-289-30EA - Each61919-289b1a95c26-b0ab-4290-8ef3-d32c445e8fba12019-04-11
61919-289-60EA - Each61919-2890fdcbb34-622a-420f-8253-fab558c6c27612019-04-11
61919-289-90EA - Each61919-28905d3621f-afc2-45a1-87dc-1d988bbf604e12019-09-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Amitriptyline HydrochlorideACTIVE INGREDIENT26LUD4JO9KAMITRIPTYLINE HYDROCHLORIDE TABLET [DIRECT RX]1
AMITRIPTYLINEACTIVE MOIETY1806D8D52KAMITRIPTYLINE HYDROCHLORIDE TABLET [DIRECT RX]1
Calcium SulfateINACTIVE INGREDIENTWAT0DDB505AMITRIPTYLINE HYDROCHLORIDE TABLET [DIRECT RX]1
Cellulose, MicrocrystallineINACTIVE INGREDIENTOP1R32D61UAMITRIPTYLINE HYDROCHLORIDE TABLET [DIRECT RX]1
Hydroxypropyl CelluloseINACTIVE INGREDIENTRFW2ET671PAMITRIPTYLINE HYDROCHLORIDE TABLET [DIRECT RX]1
HypromellosesINACTIVE INGREDIENT3NXW29V3WOAMITRIPTYLINE HYDROCHLORIDE TABLET [DIRECT RX]1
Magnesium StearateINACTIVE INGREDIENT70097M6I30AMITRIPTYLINE HYDROCHLORIDE TABLET [DIRECT RX]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AAMITRIPTYLINE HYDROCHLORIDE TABLET [DIRECT RX]1
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU4AMITRIPTYLINE HYDROCHLORIDE TABLET [DIRECT RX]1
Sodium Lauryl SulfateINACTIVE INGREDIENT368GB5141JAMITRIPTYLINE HYDROCHLORIDE TABLET [DIRECT RX]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2AMITRIPTYLINE HYDROCHLORIDE TABLET [DIRECT RX]1
Starch, CornINACTIVE INGREDIENTO8232NY3SJAMITRIPTYLINE HYDROCHLORIDE TABLET [DIRECT RX]1
TalcINACTIVE INGREDIENT7SEV7J4R1UAMITRIPTYLINE HYDROCHLORIDE TABLET [DIRECT RX]1
Titanium DioxideINACTIVE INGREDIENT15FIX9V2JPAMITRIPTYLINE HYDROCHLORIDE TABLET [DIRECT RX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-289AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX]4Legacy NDC, 1 package rows20190328_6dc30652-39c8-49a9-b411-3d238bc0ef1a.zip
61919-289AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [DIRECT_RX]2Legacy NDC, 1 package rows20221007_8e6eeec4-73fa-fd12-e053-2995a90a4ea8.zip
61919-289AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX]2Legacy NDC, 1 package rows20190330_4b7fcf0c-6d2c-20b2-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856773amitriptyline HCl 150 MG Oral TabletPSN6dc30652-39c8-49a9-b411-3d238bc0ef1a4
856834amitriptyline HCl 25 MG Oral TabletPSN6dc30652-39c8-49a9-b411-3d238bc0ef1a4
856773amitriptyline hydrochloride 150 MG Oral TabletSCD6dc30652-39c8-49a9-b411-3d238bc0ef1a4
856834amitriptyline hydrochloride 25 MG Oral TabletSCD6dc30652-39c8-49a9-b411-3d238bc0ef1a4
856783amitriptyline HCl 10 MG Oral TabletPSN4b7fcf0c-6d2c-20b2-e054-00144ff8d46c2
856834amitriptyline HCl 25 MG Oral TabletPSN4b7fcf0c-6d2c-20b2-e054-00144ff8d46c2
856834amitriptyline HCl 25 MG Oral TabletPSN8e6eeec4-73fa-fd12-e053-2995a90a4ea82
856783amitriptyline hydrochloride 10 MG Oral TabletSCD4b7fcf0c-6d2c-20b2-e054-00144ff8d46c2
856834amitriptyline hydrochloride 25 MG Oral TabletSCD4b7fcf0c-6d2c-20b2-e054-00144ff8d46c2
856834amitriptyline hydrochloride 25 MG Oral TabletSCD8e6eeec4-73fa-fd12-e053-2995a90a4ea82

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61919-289-306191902893030 TABLET, FILM COATED in 1 BOTTLE (61919-289-30) 2019-03-290000-00-00NoNoCurrent
61919-289-606191902896060 TABLET, FILM COATED in 1 BOTTLE (61919-289-60) 2019-03-270000-00-00NoNoCurrent
61919-289-906191902899090 TABLET, FILM COATED in 1 BOTTLE (61919-289-90) 2019-07-240000-00-00NoNoCurrent