FDA.reportPublic FDA data

Amitriptyline Hydrochloride

Product NDC
71335-1256
11-digit product format
713351256
Labeler code
71335
Product ID
71335-1256_0f092778-43f5-15d0-e063-6394a90a1215
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amitriptyline Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA089399
Marketing category
ANDA
Marketing start
1987-07-14
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
71335-1256-1Amitriptyline Hydrochloride100 in 1 BOTTLETABLET, FILM COATED100101
71335-1256-2Amitriptyline Hydrochloride30 in 1 BOTTLETABLET, FILM COATED30101
71335-1256-3Amitriptyline Hydrochloride60 in 1 BOTTLETABLET, FILM COATED60101
71335-1256-4Amitriptyline Hydrochloride90 in 1 BOTTLETABLET, FILM COATED90101
71335-1256-5Amitriptyline Hydrochloride20 in 1 BOTTLETABLET, FILM COATED20101
71335-1256-6Amitriptyline Hydrochloride28 in 1 BOTTLETABLET, FILM COATED28101
71335-1256-7Amitriptyline Hydrochloride56 in 1 BOTTLETABLET, FILM COATED56101
71335-1256-8Amitriptyline Hydrochloride180 in 1 BOTTLETABLET, FILM COATED180101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1256-2EA - Each71335-12568096fbd9-130d-4530-bc50-b3c95a31301e12019-09-05
71335-1256-3EA - Each71335-12564c956f9f-bbd3-4820-8a6c-09a7505e846212019-09-05
71335-1256-4EA - Each71335-125666163a15-f786-43af-8a69-15316eab0bc912019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1256AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]101Current NDC, Legacy NDC, 8 package rows20240117_dcdeb999-412e-475f-a21d-2e0ac42d136e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856845amitriptyline HCl 50 MG Oral TabletPSNdcdeb999-412e-475f-a21d-2e0ac42d136e101
856845amitriptyline hydrochloride 50 MG Oral TabletSCDdcdeb999-412e-475f-a21d-2e0ac42d136e101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1256-171335125601100 TABLET, FILM COATED in 1 BOTTLE (71335-1256-1) 2022-02-090000-00-00NoNoCurrent
71335-1256-27133512560230 TABLET, FILM COATED in 1 BOTTLE (71335-1256-2) 2022-02-090000-00-00NoNoCurrent
71335-1256-37133512560360 TABLET, FILM COATED in 1 BOTTLE (71335-1256-3) 2022-02-090000-00-00NoNoCurrent
71335-1256-47133512560490 TABLET, FILM COATED in 1 BOTTLE (71335-1256-4) 2022-02-090000-00-00NoNoCurrent
71335-1256-57133512560520 TABLET, FILM COATED in 1 BOTTLE (71335-1256-5) 2022-02-090000-00-00NoNoCurrent
71335-1256-67133512560628 TABLET, FILM COATED in 1 BOTTLE (71335-1256-6) 2022-02-090000-00-00NoNoCurrent
71335-1256-77133512560756 TABLET, FILM COATED in 1 BOTTLE (71335-1256-7) 2022-02-090000-00-00NoNoCurrent
71335-1256-871335125608180 TABLET, FILM COATED in 1 BOTTLE (71335-1256-8) 2022-02-090000-00-00NoNoCurrent