FDA.reportPublic FDA data

Amitriptyline Hydrochloride

Product NDC
71335-9637
11-digit product format
713359637
Labeler code
71335
Product ID
71335-9637_f63ca42e-4029-4227-bd7a-3145678dc63d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amitriptyline Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
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
71335-9637-0Amitriptyline Hydrochloride100 in 1 BOTTLETABLET, FILM COATED100104
71335-9637-1Amitriptyline Hydrochloride30 in 1 BOTTLETABLET, FILM COATED30104
71335-9637-2Amitriptyline Hydrochloride15 in 1 BOTTLETABLET, FILM COATED15104
71335-9637-3Amitriptyline Hydrochloride60 in 1 BOTTLETABLET, FILM COATED60104
71335-9637-4Amitriptyline Hydrochloride90 in 1 BOTTLETABLET, FILM COATED90104
71335-9637-5Amitriptyline Hydrochloride28 in 1 BOTTLETABLET, FILM COATED28104
71335-9637-6Amitriptyline Hydrochloride120 in 1 BOTTLETABLET, FILM COATED120104
71335-9637-7Amitriptyline Hydrochloride50 in 1 BOTTLETABLET, FILM COATED50104
71335-9637-8Amitriptyline Hydrochloride180 in 1 BOTTLETABLET, FILM COATED180104
71335-9637-9Amitriptyline Hydrochloride6 in 1 BOTTLETABLET, FILM COATED6104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-9637-0EA - Each71335-9637f11a31cb-dd58-4eb7-8a24-1812e2c3c12d12025-05-14
71335-9637-1EA - Each71335-9637a6a6d742-51bf-4d81-8663-04221457897a12023-05-05
71335-9637-3EA - Each71335-9637702e4190-e46a-4bb0-852f-843e7fe6c91612025-12-16
71335-9637-4EA - Each71335-96373f35712e-7165-41a5-bf15-34b1788c822212025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-9637AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]104Current NDC, 10 package rows20240829_8c9f605f-ac13-442f-af4d-ea11102474de.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856783amitriptyline HCl 10 MG Oral TabletPSN8c9f605f-ac13-442f-af4d-ea11102474de104
856783amitriptyline hydrochloride 10 MG Oral TabletSCD8c9f605f-ac13-442f-af4d-ea11102474de104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-9637-071335963700100 TABLET, FILM COATED in 1 BOTTLE (71335-9637-0) 2023-02-06NoNoHistorical
71335-9637-17133596370130 TABLET, FILM COATED in 1 BOTTLE (71335-9637-1) 2023-02-06NoNoHistorical
71335-9637-27133596370215 TABLET, FILM COATED in 1 BOTTLE (71335-9637-2) 2023-02-06NoNoHistorical
71335-9637-37133596370360 TABLET, FILM COATED in 1 BOTTLE (71335-9637-3) 2023-02-06NoNoHistorical
71335-9637-47133596370490 TABLET, FILM COATED in 1 BOTTLE (71335-9637-4) 2023-02-06NoNoHistorical
71335-9637-57133596370528 TABLET, FILM COATED in 1 BOTTLE (71335-9637-5) 2023-02-06NoNoHistorical
71335-9637-671335963706120 TABLET, FILM COATED in 1 BOTTLE (71335-9637-6) 2023-02-06NoNoHistorical
71335-9637-77133596370750 TABLET, FILM COATED in 1 BOTTLE (71335-9637-7) 2023-02-06NoNoHistorical
71335-9637-871335963708180 TABLET, FILM COATED in 1 BOTTLE (71335-9637-8) 2023-02-06NoNoHistorical
71335-9637-9713359637096 TABLET, FILM COATED in 1 BOTTLE (71335-9637-9) 2023-02-06NoNoHistorical