FDA.reportPublic FDA data

Amitriptyline Hydrochloride

Product NDC
70518-4088
11-digit product format
705184088
Labeler code
70518
Product ID
70518-4088_415be218-61e2-6622-e063-6394a90a8292
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amitriptyline Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA217411
Marketing category
ANDA
Marketing start
2024-05-28
Substance
AMITRIPTYLINE HYDROCHLORIDE
Active strength
25 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 HYDROCHLORIDE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii26LUD4JO9K
Rxcui856834

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
70518-4088-0Amitriptyline Hydrochloride90 in 1 BOTTLE, PLASTICTABLET905
70518-4088-1Amitriptyline Hydrochloride30 in 1 BLISTER PACKTABLET305
70518-4088-2Amitriptyline Hydrochloride90 in 1 BOTTLE, PLASTICTABLET905
70518-4088-3Amitriptyline Hydrochloride60 in 1 BOTTLE, PLASTICTABLET605
70518-4088-4Amitriptyline Hydrochloride30 in 1 BOTTLE, PLASTICTABLET305

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-4088AMITRIPTYLINE HYDROCHLORIDE TABLET [REMEDYREPACK INC.]2Current NDC, 5 package rows20240727_4132f91e-6f24-476a-9028-bab86ad0598e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856834amitriptyline HCl 25 MG Oral TabletPSN4132f91e-6f24-476a-9028-bab86ad0598e5
856834amitriptyline hydrochloride 25 MG Oral TabletSCD4132f91e-6f24-476a-9028-bab86ad0598e5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-4088-07051840880090 TABLET in 1 BOTTLE, PLASTIC (70518-4088-0) 90 tablet2024-05-28NoNoHistorical
70518-4088-17051840880130 TABLET in 1 BLISTER PACK (70518-4088-1) 30 tablet2024-07-25NoNoHistorical
70518-4088-27051840880290 TABLET in 1 BOTTLE, PLASTIC (70518-4088-2) 90 tablet2025-06-19NoNoHistorical
70518-4088-37051840880360 TABLET in 1 BOTTLE, PLASTIC (70518-4088-3) 60 tablet2025-06-19NoNoHistorical
70518-4088-47051840880430 TABLET in 1 BOTTLE, PLASTIC (70518-4088-4) 30 tablet2025-10-17NoNoHistorical