Amitriptyline Hydrochloride

Product NDC
50090-6179
11-digit product format
500906179
Labeler code
50090
Product ID
50090-6179_252c626f-1abb-4bd4-880b-504beb9ae6c7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amitriptyline Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA214548
Marketing category
ANDA
Marketing start
2021-05-26
Substance
AMITRIPTYLINE HYDROCHLORIDE
Active strength
10 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 HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii26LUD4JO9K
Rxcui856783

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
50090-6179-0Amitriptyline Hydrochloride30 in 1 BOTTLETABLET, FILM COATED305
50090-6179-1Amitriptyline Hydrochloride100 in 1 BOTTLETABLET, FILM COATED1005
50090-6179-6Amitriptyline Hydrochloride90 in 1 BOTTLETABLET, FILM COATED905
50090-6179-7Amitriptyline Hydrochloride60 in 1 BOTTLETABLET, FILM COATED605

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6179-0EA - Each50090-617921691713-92c1-4300-87c4-91fbbf5bfb9012022-12-07
50090-6179-1EA - Each50090-617946343c5f-53c1-4bfa-8577-31b9a552935312022-12-07
50090-6179-6EA - Each50090-6179841c6d65-ab34-4c2d-b38e-972ba09b78d812022-12-07
50090-6179-7EA - Each50090-6179f9c44cdb-5782-4bdb-ab6d-6aa2d7e20a6c12024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6179AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]5Current NDC, Legacy NDC, 4 package rows20231223_00d11130-c9ae-4258-9746-9763bc5deb84.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856783amitriptyline HCl 10 MG Oral TabletPSN00d11130-c9ae-4258-9746-9763bc5deb845
856783amitriptyline hydrochloride 10 MG Oral TabletSCD00d11130-c9ae-4258-9746-9763bc5deb845

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-6179-05009061790030 TABLET, FILM COATED in 1 BOTTLE (50090-6179-0) 2022-10-200000-00-00NoNoCurrent
50090-6179-150090617901100 TABLET, FILM COATED in 1 BOTTLE (50090-6179-1) 2022-10-200000-00-00NoNoCurrent
50090-6179-65009061790690 TABLET, FILM COATED in 1 BOTTLE (50090-6179-6) 2022-10-200000-00-00NoNoCurrent
50090-6179-75009061790760 TABLET, FILM COATED in 1 BOTTLE (50090-6179-7) 2023-12-21NoNoCurrent