FDA.reportPublic FDA data

Amitriptyline Hydrochloride

Product NDC
50090-4005
11-digit product format
500904005
Labeler code
50090
Product ID
50090-4005_d8bc1bbb-9f8c-439b-b3b8-000fa58fdcf3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amitriptyline Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA210086
Marketing category
ANDA
Marketing start
2017-12-26
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
6f1277d7-db3a-63fa-be84-d390d1482706Product name120140508
aa9828b2-adf8-0dd3-9f6c-b68f39e467c1Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-4005-02024-06-12C16284748780-1f386c64a-4365-0266-e053-dadaa90a7c1aAmitriptyline Hydrochloride Tablets, USP
50090-4005-12024-06-12C16284748780-1f386c64a-4365-0266-e053-dadaa90a7c1aAmitriptyline Hydrochloride Tablets, USP
50090-4005-42024-06-12C16284748780-1f386c64a-4365-0266-e053-dadaa90a7c1aAmitriptyline Hydrochloride Tablets, USP
50090-4005-82024-06-12C16284748780-1f386c64a-4365-0266-e053-dadaa90a7c1aAmitriptyline Hydrochloride Tablets, USP
50090-4005-02023-01-30C16284748780-1f386c64a-4365-0266-e053-dadaa90a7c1aAmitriptyline Hydrochloride Tablets, USP
50090-4005-12023-01-30C16284748780-1f386c64a-4365-0266-e053-dadaa90a7c1aAmitriptyline Hydrochloride Tablets, USP
50090-4005-42023-01-30C16284748780-1f386c64a-4365-0266-e053-dadaa90a7c1aAmitriptyline Hydrochloride Tablets, USP
50090-4005-82023-01-30C16284748780-1f386c64a-4365-0266-e053-dadaa90a7c1aAmitriptyline Hydrochloride Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4005-0Amitriptyline Hydrochloride30 in 1 BOTTLETABLET, FILM COATED3010
50090-4005-1Amitriptyline Hydrochloride100 in 1 BOTTLE, PLASTICTABLET, FILM COATED10010
50090-4005-4Amitriptyline Hydrochloride60 in 1 BOTTLETABLET, FILM COATED6010
50090-4005-8Amitriptyline Hydrochloride90 in 1 BOTTLE, PLASTICTABLET, FILM COATED9010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4005-0EA - Each50090-4005314ebc8c-2c90-422c-9876-5aabd54e375e12021-12-08
50090-4005-1EA - Each50090-4005dc52b16e-8327-490b-92db-03dda76793ae12021-12-08
50090-4005-4EA - Each50090-4005e554b2af-2268-4125-977d-6f137e0c20e412021-12-08
50090-4005-8EA - Each50090-4005e2133667-4db7-46a1-8cf5-d8e0c6955ca412021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4005AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]10Current NDC, Legacy NDC, 4 package rows20240613_0067b698-ee1d-4524-b1cc-af1028d13736.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856834amitriptyline HCl 25 MG Oral TabletPSN0067b698-ee1d-4524-b1cc-af1028d1373610
856834amitriptyline hydrochloride 25 MG Oral TabletSCD0067b698-ee1d-4524-b1cc-af1028d1373610

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-4005-05009040050030 TABLET, FILM COATED in 1 BOTTLE (50090-4005-0) 2018-12-270000-00-00NoNoCurrent
50090-4005-150090400501100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-4005-1) 2017-12-260000-00-00NoNoCurrent
50090-4005-45009040050460 TABLET, FILM COATED in 1 BOTTLE (50090-4005-4) 2019-02-120000-00-00NoNoCurrent
50090-4005-85009040050890 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-4005-8) 2017-12-260000-00-00NoNoCurrent