FDA.reportPublic FDA data

Amitriptyline Hydrochloride

Product NDC
80425-0439
11-digit product format
804250439
Labeler code
80425
Product ID
80425-0439_273326d2-b8f4-466a-e063-6294a90a7abb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amitriptyline Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Advanced Rx of Tennessee, LLC
Application
ANDA217411
Marketing category
ANDA
Marketing start
2024-05-24
Substance
AMITRIPTYLINE HYDROCHLORIDE
Active strength
100 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 HYDROCHLORIDE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii26LUD4JO9K
Rxcui856762, 856834

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e5006e90-7f2e-4341-bcdb-f83027a8fc39Product name620240611
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
6f1277d7-db3a-63fa-be84-d390d1482706Product name120140508
aa9828b2-adf8-0dd3-9f6c-b68f39e467c1Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0439-1Amitriptyline Hydrochloride30 in 1 BOTTLETABLET302
80425-0439-2Amitriptyline Hydrochloride60 in 1 BOTTLETABLET602
80425-0439-3Amitriptyline Hydrochloride90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0439-1EA - Each80425-04396eed85ee-6494-48e1-92c0-5ad2c967f0aa12024-12-10
80425-0439-2EA - Each80425-04390e0532f9-d835-4c51-a37f-6d9aa43b046012024-12-10
80425-0439-3EA - Each80425-04392eae8461-c35c-4c49-84eb-e974227b472112024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0439AMITRIPTYLINE HYDROCHLORIDE TABLET [ADVANCED RX OF TENNESSEE, LLC]2Current NDC, 3 package rows20241120_19b0c015-c07f-63b7-e063-6394a90a6060.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856762amitriptyline HCl 100 MG Oral TabletPSN19b0c015-c07f-63b7-e063-6394a90a60602
856834amitriptyline HCl 25 MG Oral TabletPSN19b0c015-c07f-63b7-e063-6394a90a60602
856762amitriptyline hydrochloride 100 MG Oral TabletSCD19b0c015-c07f-63b7-e063-6394a90a60602
856834amitriptyline hydrochloride 25 MG Oral TabletSCD19b0c015-c07f-63b7-e063-6394a90a60602

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80425-0439-18042504390130 TABLET in 1 BOTTLE (80425-0439-1) 30 tablet2024-05-24NoNoHistorical
80425-0439-28042504390260 TABLET in 1 BOTTLE (80425-0439-2) 60 tablet2024-05-24NoNoHistorical
80425-0439-38042504390390 TABLET in 1 BOTTLE (80425-0439-3) 90 tablet2024-05-24NoNoHistorical