FDA.reportPublic FDA data

Amitriptyline Hydrochloride

Product NDC
71335-9635
11-digit product format
713359635
Labeler code
71335
Product ID
71335-9635_f1f451d3-722f-480e-9cfb-4ee6b6daf359
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
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
71335-9635-1Amitriptyline Hydrochloride100 in 1 BOTTLETABLET, FILM COATED100102
71335-9635-2Amitriptyline Hydrochloride30 in 1 BOTTLETABLET, FILM COATED30102
71335-9635-3Amitriptyline Hydrochloride60 in 1 BOTTLETABLET, FILM COATED60102
71335-9635-4Amitriptyline Hydrochloride90 in 1 BOTTLETABLET, FILM COATED90102
71335-9635-5Amitriptyline Hydrochloride20 in 1 BOTTLETABLET, FILM COATED20102
71335-9635-6Amitriptyline Hydrochloride28 in 1 BOTTLETABLET, FILM COATED28102
71335-9635-7Amitriptyline Hydrochloride56 in 1 BOTTLETABLET, FILM COATED56102
71335-9635-8Amitriptyline Hydrochloride180 in 1 BOTTLETABLET, FILM COATED180102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-9635-3EA - Each71335-96353c214b29-b6db-476b-8c61-68438aef635b12023-09-05
71335-9635-4EA - Each71335-9635c2a30dc0-7c9b-4207-a181-36103e04cd9c12023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-9635AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]102Current NDC, 8 package rows20240829_ac1a7640-58d7-494d-94c8-27911470bf59.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856845amitriptyline HCl 50 MG Oral TabletPSNac1a7640-58d7-494d-94c8-27911470bf59102
856845amitriptyline hydrochloride 50 MG Oral TabletSCDac1a7640-58d7-494d-94c8-27911470bf59102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-9635-171335963501100 TABLET, FILM COATED in 1 BOTTLE (71335-9635-1) 2023-02-06NoNoHistorical
71335-9635-27133596350230 TABLET, FILM COATED in 1 BOTTLE (71335-9635-2) 2023-02-06NoNoHistorical
71335-9635-37133596350360 TABLET, FILM COATED in 1 BOTTLE (71335-9635-3) 2023-02-06NoNoHistorical
71335-9635-47133596350490 TABLET, FILM COATED in 1 BOTTLE (71335-9635-4) 2023-02-06NoNoHistorical
71335-9635-57133596350520 TABLET, FILM COATED in 1 BOTTLE (71335-9635-5) 2023-02-06NoNoHistorical
71335-9635-67133596350628 TABLET, FILM COATED in 1 BOTTLE (71335-9635-6) 2023-02-06NoNoHistorical
71335-9635-77133596350756 TABLET, FILM COATED in 1 BOTTLE (71335-9635-7) 2023-02-06NoNoHistorical
71335-9635-871335963508180 TABLET, FILM COATED in 1 BOTTLE (71335-9635-8) 2023-02-06NoNoHistorical