FDA.reportPublic FDA data

Amitriptyline Hydrochloride

Product NDC
0781-1491
11-digit product format
007811491
Labeler code
0781
Product ID
0781-1491_9df45420-7268-454e-9624-8da48c97b7db
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amitriptyline Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Sandoz Inc
Application
ANDA085968
Marketing category
ANDA
Marketing start
1977-11-21
Substance
AMITRIPTYLINE HYDROCHLORIDE
Active strength
150 mg/1
Pharmacologic classes
Tricyclic Antidepressant [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Amitriptyline Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMITRIPTYLINE HYDROCHLORIDE150 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii26LUD4JO9K
Rxcui856762, 856773, 856783, 856834, 856845, 856853

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
0781-1491-012020-08-18C16284748780-1ab0e2407-2711-f274-e053-dbdaa90a6471Amitriptyline Hydrochloride Tablets, USP
0781-1491-102020-08-18C16284748780-1ab0e2407-2711-f274-e053-dbdaa90a6471Amitriptyline Hydrochloride Tablets, USP
0781-1491-312020-08-18C16284748780-1ab0e2407-2711-f274-e053-dbdaa90a6471Amitriptyline Hydrochloride Tablets, USP
0781-1491-012020-07-22C16284748780-1ab0e2407-2711-f274-e053-dbdaa90a6471Amitriptyline Hydrochloride Tablets, USP
0781-1491-102020-07-22C16284748780-1ab0e2407-2711-f274-e053-dbdaa90a6471Amitriptyline Hydrochloride Tablets, USP
0781-1491-312020-07-22C16284748780-1ab0e2407-2711-f274-e053-dbdaa90a6471Amitriptyline Hydrochloride Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0781-1491-01Amitriptyline Hydrochloride100 in 1 BOTTLETABLET, FILM COATED10027
0781-1491-10Amitriptyline Hydrochloride1000 in 1 BOTTLETABLET, FILM COATED100027
0781-1491-31Amitriptyline Hydrochloride30 in 1 BOTTLETABLET, FILM COATED3027

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-1491-01EA - Each0781-1491d2a130bc-468c-4f72-9f07-67ed76c556f812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMITRIPTYLINE HYDROCHLORIDEACTIVE INGREDIENT26LUD4JO9KAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [SANDOZ INC]16
AMITRIPTYLINEACTIVE MOIETY1806D8D52KAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [SANDOZ INC]16
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [SANDOZ INC]16
D&C RED NO. 27INACTIVE INGREDIENT2LRS185U6KAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [SANDOZ INC]16
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [SANDOZ INC]16
D&C RED NO. 7INACTIVE INGREDIENTECW0LZ41X8AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [SANDOZ INC]16
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [SANDOZ INC]16
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [SANDOZ INC]16
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [SANDOZ INC]16
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [SANDOZ INC]16
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [SANDOZ INC]16
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [SANDOZ INC]16
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [SANDOZ INC]16
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [SANDOZ INC]16
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [SANDOZ INC]16
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [SANDOZ INC]16
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [SANDOZ INC]16
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [SANDOZ INC]16
AMITRIPTYLINE HYDROCHLORIDEACTIVE INGREDIENT26LUD4JO9KAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
AMITRIPTYLINEACTIVE MOIETY1806D8D52KAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
D&C RED NO. 27INACTIVE INGREDIENT2LRS185U6KAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
D&C RED NO. 7INACTIVE INGREDIENTECW0LZ41X8AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1AAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0781-1491AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [SANDOZ INC]26Current NDC, Legacy NDC, 3 package rows20240322_705a2bae-031d-4218-82fe-4346542c0baa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856783amitriptyline HCl 10 MG Oral TabletPSN705a2bae-031d-4218-82fe-4346542c0baa27
856762amitriptyline HCl 100 MG Oral TabletPSN705a2bae-031d-4218-82fe-4346542c0baa27
856773amitriptyline HCl 150 MG Oral TabletPSN705a2bae-031d-4218-82fe-4346542c0baa27
856834amitriptyline HCl 25 MG Oral TabletPSN705a2bae-031d-4218-82fe-4346542c0baa27
856845amitriptyline HCl 50 MG Oral TabletPSN705a2bae-031d-4218-82fe-4346542c0baa27
856853amitriptyline HCl 75 MG Oral TabletPSN705a2bae-031d-4218-82fe-4346542c0baa27
856783amitriptyline hydrochloride 10 MG Oral TabletSCD705a2bae-031d-4218-82fe-4346542c0baa27
856762amitriptyline hydrochloride 100 MG Oral TabletSCD705a2bae-031d-4218-82fe-4346542c0baa27
856773amitriptyline hydrochloride 150 MG Oral TabletSCD705a2bae-031d-4218-82fe-4346542c0baa27
856834amitriptyline hydrochloride 25 MG Oral TabletSCD705a2bae-031d-4218-82fe-4346542c0baa27
856845amitriptyline hydrochloride 50 MG Oral TabletSCD705a2bae-031d-4218-82fe-4346542c0baa27
856853amitriptyline hydrochloride 75 MG Oral TabletSCD705a2bae-031d-4218-82fe-4346542c0baa27
856783amitriptyline HCl 10 MG Oral TabletPSN8bf65c7f-4c8d-4df5-85e0-3ea1cc79a75c2
856762amitriptyline HCl 100 MG Oral TabletPSN8bf65c7f-4c8d-4df5-85e0-3ea1cc79a75c2
856773amitriptyline HCl 150 MG Oral TabletPSN8bf65c7f-4c8d-4df5-85e0-3ea1cc79a75c2
856834amitriptyline HCl 25 MG Oral TabletPSN8bf65c7f-4c8d-4df5-85e0-3ea1cc79a75c2
856845amitriptyline HCl 50 MG Oral TabletPSN8bf65c7f-4c8d-4df5-85e0-3ea1cc79a75c2
856853amitriptyline HCl 75 MG Oral TabletPSN8bf65c7f-4c8d-4df5-85e0-3ea1cc79a75c2
856783amitriptyline hydrochloride 10 MG Oral TabletSCD8bf65c7f-4c8d-4df5-85e0-3ea1cc79a75c2
856762amitriptyline hydrochloride 100 MG Oral TabletSCD8bf65c7f-4c8d-4df5-85e0-3ea1cc79a75c2
856773amitriptyline hydrochloride 150 MG Oral TabletSCD8bf65c7f-4c8d-4df5-85e0-3ea1cc79a75c2
856834amitriptyline hydrochloride 25 MG Oral TabletSCD8bf65c7f-4c8d-4df5-85e0-3ea1cc79a75c2
856845amitriptyline hydrochloride 50 MG Oral TabletSCD8bf65c7f-4c8d-4df5-85e0-3ea1cc79a75c2
856853amitriptyline hydrochloride 75 MG Oral TabletSCD8bf65c7f-4c8d-4df5-85e0-3ea1cc79a75c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0781-1491-0100781149101100 TABLET, FILM COATED in 1 BOTTLE (0781-1491-01) 1977-11-210000-00-00NoNoCurrent
0781-1491-10007811491101000 in 1 BOTTLEHistorical
0781-1491-310078114913130 in 1 BOTTLEHistorical