FDA.reportPublic FDA data

Amitriptyline Hydrochloride

Product NDC
50268-041
11-digit product format
502680041
Labeler code
50268
Product ID
50268-041_2b489726-9f79-c6d3-e063-6294a90a1ff3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amitriptyline Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
AvPAK
Application
ANDA214548
Marketing category
ANDA
Marketing start
2023-02-28
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

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50268-041-11Amitriptyline Hydrochloride1 in 1 BLISTER PACKTABLET, FILM COATED12
50268-041-15Amitriptyline Hydrochloride50 in 1 BOXTABLET, FILM COATED502

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-041-11EA - Each50268-0416badbe43-a03f-4d1a-b1e1-a13f5d838c3612023-07-06
50268-041-15EA - Each50268-0417f4f9ee9-3d73-4f96-a9ee-0a31741c035012023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-041AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [AVPAK]2Current NDC, 2 package rows20250112_f5c5f3b6-e92b-1120-e053-2995a90ae8fa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856762amitriptyline HCl 100 MG Oral TabletPSNf5c5f3b6-e92b-1120-e053-2995a90ae8fa2
856762amitriptyline hydrochloride 100 MG Oral TabletSCDf5c5f3b6-e92b-1120-e053-2995a90ae8fa2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50268-041-11502680041111 in 1 BLISTER PACKHistorical
50268-041-155026800411550 BLISTER PACK in 1 BOX (50268-041-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-041-11) 50 blister pack2023-02-28NoNoHistorical