FDA.reportPublic FDA data

Amitriptyline Hydrochloride

Product NDC
0781-1489
11-digit product format
007811489
Labeler code
0781
Product ID
0781-1489_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
1977-11-29
Substance
AMITRIPTYLINE HYDROCHLORIDE
Active strength
75 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 HYDROCHLORIDE75 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
0781-1489-012020-08-18C16284748780-1ab0e2407-2711-f274-e053-dbdaa90a6471Amitriptyline Hydrochloride Tablets, USP
0781-1489-102020-08-18C16284748780-1ab0e2407-2711-f274-e053-dbdaa90a6471Amitriptyline Hydrochloride Tablets, USP
0781-1489-312020-08-18C16284748780-1ab0e2407-2711-f274-e053-dbdaa90a6471Amitriptyline Hydrochloride Tablets, USP
0781-1489-012020-07-22C16284748780-1ab0e2407-2711-f274-e053-dbdaa90a6471Amitriptyline Hydrochloride Tablets, USP
0781-1489-102020-07-22C16284748780-1ab0e2407-2711-f274-e053-dbdaa90a6471Amitriptyline Hydrochloride Tablets, USP
0781-1489-312020-07-22C16284748780-1ab0e2407-2711-f274-e053-dbdaa90a6471Amitriptyline Hydrochloride Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0781-1489-01Amitriptyline Hydrochloride100 in 1 BOTTLETABLET, FILM COATED10027
0781-1489-10Amitriptyline Hydrochloride1000 in 1 BOTTLETABLET, FILM COATED100027
0781-1489-31Amitriptyline Hydrochloride30 in 1 BOTTLETABLET, FILM COATED3027

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0781-1489AMITRIPTYLINE 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 TabletPSNeab6fbd5-50ca-4c52-bbe7-29d72d647daa4
856834amitriptyline HCl 25 MG Oral TabletPSNeab6fbd5-50ca-4c52-bbe7-29d72d647daa4
856853amitriptyline HCl 75 MG Oral TabletPSNeab6fbd5-50ca-4c52-bbe7-29d72d647daa4
856783amitriptyline hydrochloride 10 MG Oral TabletSCDeab6fbd5-50ca-4c52-bbe7-29d72d647daa4
856834amitriptyline hydrochloride 25 MG Oral TabletSCDeab6fbd5-50ca-4c52-bbe7-29d72d647daa4
856853amitriptyline hydrochloride 75 MG Oral TabletSCDeab6fbd5-50ca-4c52-bbe7-29d72d647daa4
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
856762amitriptyline HCl 100 MG Oral TabletPSN460a2e4d-f1a2-4e08-b2da-f10bc63391db1
856834amitriptyline HCl 25 MG Oral TabletPSN460a2e4d-f1a2-4e08-b2da-f10bc63391db1
856845amitriptyline HCl 50 MG Oral TabletPSN460a2e4d-f1a2-4e08-b2da-f10bc63391db1
856853amitriptyline HCl 75 MG Oral TabletPSN460a2e4d-f1a2-4e08-b2da-f10bc63391db1
856762amitriptyline hydrochloride 100 MG Oral TabletSCD460a2e4d-f1a2-4e08-b2da-f10bc63391db1
856834amitriptyline hydrochloride 25 MG Oral TabletSCD460a2e4d-f1a2-4e08-b2da-f10bc63391db1
856845amitriptyline hydrochloride 50 MG Oral TabletSCD460a2e4d-f1a2-4e08-b2da-f10bc63391db1
856853amitriptyline hydrochloride 75 MG Oral TabletSCD460a2e4d-f1a2-4e08-b2da-f10bc63391db1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0781-1489-0100781148901100 TABLET, FILM COATED in 1 BOTTLE (0781-1489-01) 1977-11-290000-00-00NoNoCurrent
0781-1489-10007811489101000 in 1 BOTTLEHistorical
0781-1489-310078114893130 in 1 BOTTLEHistorical