Amitriptyline Hydrochloride

Product NDC
50090-7183
11-digit product format
500907183
Labeler code
50090
Product ID
50090-7183_b8f0f192-6383-4b21-ac0a-30ff64acd54f
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
2021-08-25
Substance
AMITRIPTYLINE HYDROCHLORIDE
Active strength
50 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 HYDROCHLORIDE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii26LUD4JO9K
Rxcui856845

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
50090-7183-0Amitriptyline Hydrochloride100 in 1 BOTTLETABLET, FILM COATED1001
50090-7183-1Amitriptyline Hydrochloride30 in 1 BOTTLETABLET, FILM COATED301
50090-7183-2Amitriptyline Hydrochloride60 in 1 BOTTLETABLET, FILM COATED601
50090-7183-5Amitriptyline Hydrochloride90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7183-0EA - Each50090-71833b255926-d0dd-4c20-b285-a051b39eaf8812024-07-12
50090-7183-1EA - Each50090-718323ffb808-94f8-449c-9010-b502efaa8bee12024-07-12
50090-7183-2EA - Each50090-718364423596-5b9e-4a7c-a49c-40875b72208412024-07-12
50090-7183-5EA - Each50090-7183dbde0f80-2eef-4e0b-97f6-54b826d7b0b912024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-7183AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]1Current NDC, 4 package rows20240626_b793f1f8-c1f9-46f0-8156-1a4957db3a1f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856845amitriptyline HCl 50 MG Oral TabletPSNb793f1f8-c1f9-46f0-8156-1a4957db3a1f1
856845amitriptyline hydrochloride 50 MG Oral TabletSCDb793f1f8-c1f9-46f0-8156-1a4957db3a1f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-7183-050090718300100 TABLET, FILM COATED in 1 BOTTLE (50090-7183-0) 2024-06-18NoNoCurrent
50090-7183-15009071830130 TABLET, FILM COATED in 1 BOTTLE (50090-7183-1) 2024-06-18NoNoCurrent
50090-7183-25009071830260 TABLET, FILM COATED in 1 BOTTLE (50090-7183-2) 2024-06-18NoNoCurrent
50090-7183-55009071830590 TABLET, FILM COATED in 1 BOTTLE (50090-7183-5) 2024-06-18NoNoCurrent