FDA.reportPublic FDA data

Amitriptyline Hydrochloride

Product NDC
71335-2491
11-digit product format
713352491
Labeler code
71335
Product ID
71335-2491_c58faa46-f8c1-4bb3-84aa-18ac06101a8d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amitriptyline Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
6f1277d7-db3a-63fa-be84-d390d1482706Product name120140508
aa9828b2-adf8-0dd3-9f6c-b68f39e467c1Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-2491-1Amitriptyline Hydrochloride100 in 1 BOTTLETABLET1001
71335-2491-2Amitriptyline Hydrochloride30 in 1 BOTTLETABLET301
71335-2491-3Amitriptyline Hydrochloride60 in 1 BOTTLETABLET601
71335-2491-4Amitriptyline Hydrochloride90 in 1 BOTTLETABLET901
71335-2491-5Amitriptyline Hydrochloride20 in 1 BOTTLETABLET201
71335-2491-6Amitriptyline Hydrochloride28 in 1 BOTTLETABLET281
71335-2491-7Amitriptyline Hydrochloride56 in 1 BOTTLETABLET561
71335-2491-8Amitriptyline Hydrochloride180 in 1 BOTTLETABLET1801

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2491-1EA - Each71335-2491519e4374-a7e8-43d0-8b1a-0da87d64f04012025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2491AMITRIPTYLINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1Current NDC, 8 package rows20240918_3d9292dc-49a0-46f4-9980-3e8d57121d43.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856845amitriptyline HCl 50 MG Oral TabletPSN3d9292dc-49a0-46f4-9980-3e8d57121d431
856845amitriptyline hydrochloride 50 MG Oral TabletSCD3d9292dc-49a0-46f4-9980-3e8d57121d431

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2491-171335249101100 TABLET in 1 BOTTLE (71335-2491-1) 100 tablet2024-09-16NoNoHistorical
71335-2491-27133524910230 TABLET in 1 BOTTLE (71335-2491-2) 30 tablet2024-09-16NoNoHistorical
71335-2491-37133524910360 TABLET in 1 BOTTLE (71335-2491-3) 60 tablet2024-09-16NoNoHistorical
71335-2491-47133524910490 TABLET in 1 BOTTLE (71335-2491-4) 90 tablet2024-09-16NoNoHistorical
71335-2491-57133524910520 TABLET in 1 BOTTLE (71335-2491-5) 20 tablet2024-09-16NoNoHistorical
71335-2491-67133524910628 TABLET in 1 BOTTLE (71335-2491-6) 28 tablet2024-09-16NoNoHistorical
71335-2491-77133524910756 TABLET in 1 BOTTLE (71335-2491-7) 56 tablet2024-09-16NoNoHistorical
71335-2491-871335249108180 TABLET in 1 BOTTLE (71335-2491-8) 180 tablet2024-09-16NoNoHistorical