FDA.reportPublic FDA data

Amitriptyline Hydrochloride

Product NDC
71335-2802
11-digit product format
713352802
Labeler code
71335
Product ID
71335-2802_b24ae4bb-d299-4a13-9cbe-6568dc4090cd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amitriptyline Hydrochloride
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA212654
Marketing category
ANDA
Marketing start
2024-05-20
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
71335-2802-1Amitriptyline Hydrochloride100 in 1 BOTTLETABLET, COATED1001
71335-2802-2Amitriptyline Hydrochloride30 in 1 BOTTLETABLET, COATED301
71335-2802-3Amitriptyline Hydrochloride60 in 1 BOTTLETABLET, COATED601
71335-2802-4Amitriptyline Hydrochloride90 in 1 BOTTLETABLET, COATED901
71335-2802-5Amitriptyline Hydrochloride20 in 1 BOTTLETABLET, COATED201
71335-2802-6Amitriptyline Hydrochloride28 in 1 BOTTLETABLET, COATED281
71335-2802-7Amitriptyline Hydrochloride56 in 1 BOTTLETABLET, COATED561
71335-2802-8Amitriptyline Hydrochloride180 in 1 BOTTLETABLET, COATED1801

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856845amitriptyline HCl 50 MG Oral TabletPSNdb4d83b8-3ce7-433e-b32a-a8dc2f44b9091
856845amitriptyline hydrochloride 50 MG Oral TabletSCDdb4d83b8-3ce7-433e-b32a-a8dc2f44b9091

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-2802-171335280201100 TABLET, COATED in 1 BOTTLE (71335-2802-1) 2025-10-03NoNoHistorical
71335-2802-27133528020230 TABLET, COATED in 1 BOTTLE (71335-2802-2) 2025-10-03NoNoHistorical
71335-2802-37133528020360 TABLET, COATED in 1 BOTTLE (71335-2802-3) 2025-10-03NoNoHistorical
71335-2802-47133528020490 TABLET, COATED in 1 BOTTLE (71335-2802-4) 2025-10-03NoNoHistorical
71335-2802-57133528020520 TABLET, COATED in 1 BOTTLE (71335-2802-5) 2025-10-03NoNoHistorical
71335-2802-67133528020628 TABLET, COATED in 1 BOTTLE (71335-2802-6) 2025-10-03NoNoHistorical
71335-2802-77133528020756 TABLET, COATED in 1 BOTTLE (71335-2802-7) 2025-10-03NoNoHistorical
71335-2802-871335280208180 TABLET, COATED in 1 BOTTLE (71335-2802-8) 2025-10-03NoNoHistorical