Amitriptyline Hydrochloride

Product NDC
50090-7273
11-digit product format
500907273
Labeler code
50090
Product ID
50090-7273_843b6456-b3c0-4521-8e65-463fef640e30
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amitriptyline Hydrochloride
Dosage form
TABLET, COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA212654
Marketing category
ANDA
Marketing start
2024-05-20
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-7273-0Amitriptyline Hydrochloride90 in 1 BOTTLETABLET, COATED903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7273-0EA - Each50090-72737bcb34a4-170e-49be-bab9-17b3c0c6188b12024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-7273AMITRIPTYLINE HYDROCHLORIDE TABLET, COATED [A-S MEDICATION SOLUTIONS]1Current NDC, 1 package rows20241015_085baad2-d1c7-499e-b553-7477befd04d0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856834amitriptyline HCl 25 MG Oral TabletPSN085baad2-d1c7-499e-b553-7477befd04d03
856834amitriptyline hydrochloride 25 MG Oral TabletSCD085baad2-d1c7-499e-b553-7477befd04d03

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-7273-05009072730090 TABLET, COATED in 1 BOTTLE (50090-7273-0) 2024-10-08NoNoHistorical