FDA.reportPublic FDA data

Amitriptyline Hydrochloride

Product NDC
50090-7598
11-digit product format
500907598
Labeler code
50090
Product ID
50090-7598_3cd066c4-eb34-43bc-a6ce-1e9d4a877162
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amitriptyline Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA217411
Marketing category
ANDA
Marketing start
2023-06-10
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
50090-7598-0Amitriptyline Hydrochloride100 in 1 BOTTLETABLET1001
50090-7598-1Amitriptyline Hydrochloride30 in 1 BOTTLETABLET301
50090-7598-2Amitriptyline Hydrochloride60 in 1 BOTTLETABLET601
50090-7598-5Amitriptyline Hydrochloride90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7598-0EA - Each50090-7598cf7b1cd6-922a-42f6-abf3-62d20ce7265c12025-08-11
50090-7598-1EA - Each50090-75988b8d98df-f238-4917-b99f-79834b5cc1f712025-08-11
50090-7598-2EA - Each50090-7598709c64b6-8083-4963-b698-4104929b6f8012025-08-11
50090-7598-5EA - Each50090-7598330bfb48-b8a8-41e0-a114-bff1e24fee7f12025-08-11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856845amitriptyline HCl 50 MG Oral TabletPSN9110367c-4104-4836-8af3-649f86b0b3ea1
856845amitriptyline hydrochloride 50 MG Oral TabletSCD9110367c-4104-4836-8af3-649f86b0b3ea1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-7598-050090759800100 TABLET in 1 BOTTLE (50090-7598-0) 100 tablet2025-07-07NoNoCurrent
50090-7598-15009075980130 TABLET in 1 BOTTLE (50090-7598-1) 30 tablet2025-07-07NoNoCurrent
50090-7598-25009075980260 TABLET in 1 BOTTLE (50090-7598-2) 60 tablet2025-07-07NoNoCurrent
50090-7598-55009075980590 TABLET in 1 BOTTLE (50090-7598-5) 90 tablet2025-07-07NoNoCurrent