Amitriptyline Hydrochloride

Product NDC
71335-1254
11-digit product format
713351254
Labeler code
71335
Product ID
71335-1254_0f092467-7f36-1cb2-e063-6394a90a88a2
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
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
71335-1254-0Amitriptyline Hydrochloride120 in 1 BOTTLETABLET, FILM COATED1204
71335-1254-1Amitriptyline Hydrochloride20 in 1 BOTTLETABLET, FILM COATED204
71335-1254-2Amitriptyline Hydrochloride30 in 1 BOTTLETABLET, FILM COATED304
71335-1254-3Amitriptyline Hydrochloride100 in 1 BOTTLETABLET, FILM COATED1004
71335-1254-4Amitriptyline Hydrochloride60 in 1 BOTTLETABLET, FILM COATED604
71335-1254-5Amitriptyline Hydrochloride50 in 1 BOTTLETABLET, FILM COATED504
71335-1254-6Amitriptyline Hydrochloride90 in 1 BOTTLETABLET, FILM COATED904
71335-1254-7Amitriptyline Hydrochloride45 in 1 BOTTLETABLET, FILM COATED454
71335-1254-8Amitriptyline Hydrochloride28 in 1 BOTTLETABLET, FILM COATED284
71335-1254-9Amitriptyline Hydrochloride56 in 1 BOTTLETABLET, FILM COATED564

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1254-2EA - Each71335-1254990522f4-3642-4c5a-8870-6faed5627f5112019-09-05
71335-1254-4EA - Each71335-1254baa23526-5172-4441-9c1d-2192dfb2c1c812020-09-14
71335-1254-6EA - Each71335-1254cdf8c8be-bf15-46d9-85a7-7d25296f9b9f12020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1254AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]4Current NDC, Legacy NDC, 10 package rows20240117_541ba74a-babb-4731-a5ef-fe7c18992c0b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856834amitriptyline HCl 25 MG Oral TabletPSN541ba74a-babb-4731-a5ef-fe7c18992c0b4
856834amitriptyline hydrochloride 25 MG Oral TabletSCD541ba74a-babb-4731-a5ef-fe7c18992c0b4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1254-071335125400120 TABLET, FILM COATED in 1 BOTTLE (71335-1254-0) 2021-12-280000-00-00NoNoCurrent
71335-1254-17133512540120 TABLET, FILM COATED in 1 BOTTLE (71335-1254-1) 2021-12-280000-00-00NoNoCurrent
71335-1254-27133512540230 TABLET, FILM COATED in 1 BOTTLE (71335-1254-2) 2019-07-190000-00-00NoNoCurrent
71335-1254-371335125403100 TABLET, FILM COATED in 1 BOTTLE (71335-1254-3) 2021-12-280000-00-00NoNoCurrent
71335-1254-47133512540460 TABLET, FILM COATED in 1 BOTTLE (71335-1254-4) 2019-07-240000-00-00NoNoCurrent
71335-1254-57133512540550 TABLET, FILM COATED in 1 BOTTLE (71335-1254-5) 2021-12-280000-00-00NoNoCurrent
71335-1254-67133512540690 TABLET, FILM COATED in 1 BOTTLE (71335-1254-6) 2019-06-270000-00-00NoNoCurrent
71335-1254-77133512540745 TABLET, FILM COATED in 1 BOTTLE (71335-1254-7) 2021-12-280000-00-00NoNoCurrent
71335-1254-87133512540828 TABLET, FILM COATED in 1 BOTTLE (71335-1254-8) 2021-12-280000-00-00NoNoCurrent
71335-1254-97133512540956 TABLET, FILM COATED in 1 BOTTLE (71335-1254-9) 2021-12-280000-00-00NoNoCurrent