FDA.reportPublic FDA data

Amitriptyline Hydrochloride

Product NDC
71335-2769
11-digit product format
713352769
Labeler code
71335
Product ID
71335-2769_f4fd7181-a56a-4f52-9b9f-0995f5806229
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
25 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 HYDROCHLORIDE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii26LUD4JO9K
Rxcui856834

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
71335-2769-0Amitriptyline Hydrochloride120 in 1 BOTTLETABLET, COATED1201
71335-2769-1Amitriptyline Hydrochloride20 in 1 BOTTLETABLET, COATED201
71335-2769-2Amitriptyline Hydrochloride30 in 1 BOTTLETABLET, COATED301
71335-2769-3Amitriptyline Hydrochloride100 in 1 BOTTLETABLET, COATED1001
71335-2769-4Amitriptyline Hydrochloride60 in 1 BOTTLETABLET, COATED601
71335-2769-5Amitriptyline Hydrochloride50 in 1 BOTTLETABLET, COATED501
71335-2769-6Amitriptyline Hydrochloride90 in 1 BOTTLETABLET, COATED901
71335-2769-7Amitriptyline Hydrochloride45 in 1 BOTTLETABLET, COATED451
71335-2769-8Amitriptyline Hydrochloride28 in 1 BOTTLETABLET, COATED281
71335-2769-9Amitriptyline Hydrochloride56 in 1 BOTTLETABLET, COATED561

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2769-6EA - Each71335-2769d204d298-63eb-444c-ad37-e2e67a6207e912026-04-20

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856834amitriptyline HCl 25 MG Oral TabletPSN63cd768c-4ed1-47af-901a-3835919ca4d91
856834amitriptyline hydrochloride 25 MG Oral TabletSCD63cd768c-4ed1-47af-901a-3835919ca4d91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-2769-071335276900120 TABLET, COATED in 1 BOTTLE (71335-2769-0) 2025-10-03NoNoHistorical
71335-2769-17133527690120 TABLET, COATED in 1 BOTTLE (71335-2769-1) 2025-10-03NoNoHistorical
71335-2769-27133527690230 TABLET, COATED in 1 BOTTLE (71335-2769-2) 2025-10-03NoNoHistorical
71335-2769-371335276903100 TABLET, COATED in 1 BOTTLE (71335-2769-3) 2025-10-03NoNoHistorical
71335-2769-47133527690460 TABLET, COATED in 1 BOTTLE (71335-2769-4) 2025-10-03NoNoHistorical
71335-2769-57133527690550 TABLET, COATED in 1 BOTTLE (71335-2769-5) 2025-10-03NoNoHistorical
71335-2769-67133527690690 TABLET, COATED in 1 BOTTLE (71335-2769-6) 2025-10-03NoNoHistorical
71335-2769-77133527690745 TABLET, COATED in 1 BOTTLE (71335-2769-7) 2025-10-03NoNoHistorical
71335-2769-87133527690828 TABLET, COATED in 1 BOTTLE (71335-2769-8) 2025-10-03NoNoHistorical
71335-2769-97133527690956 TABLET, COATED in 1 BOTTLE (71335-2769-9) 2025-10-03NoNoHistorical