FDA.reportPublic FDA data

Amitriptyline Hydrochloride

Product NDC
68788-8788
11-digit product format
687888788
Labeler code
68788
Product ID
68788-8788_a0b6dbb6-923e-41b2-9ae1-993aa5b52756
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amitriptyline Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA217411
Marketing category
ANDA
Marketing start
2024-12-16
Substance
AMITRIPTYLINE HYDROCHLORIDE
Active strength
75 mg/1
Pharmacologic classes
Tricyclic Antidepressant [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Amitriptyline Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMITRIPTYLINE HYDROCHLORIDE75 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii26LUD4JO9K
Rxcui856853

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
68788-8788-1Amitriptyline Hydrochloride100 in 1 BOTTLETABLET1002
68788-8788-3Amitriptyline Hydrochloride30 in 1 BOTTLETABLET302
68788-8788-6Amitriptyline Hydrochloride60 in 1 BOTTLETABLET602
68788-8788-8Amitriptyline Hydrochloride28 in 1 BOTTLETABLET282
68788-8788-9Amitriptyline Hydrochloride90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8788-1EA - Each68788-878889d2d710-a09e-4547-a0ac-9e72c0f96ee712025-02-10
68788-8788-3EA - Each68788-87884e5b572e-3fa5-407e-a958-0bebabac478f12025-02-10
68788-8788-6EA - Each68788-8788a97acbfa-63b5-4655-a697-dbf50ab4387c12025-02-10
68788-8788-8EA - Each68788-87889c298e4f-f160-4d4a-9e4e-a7612df28df112025-02-10
68788-8788-9EA - Each68788-87882f471e7a-e41a-4ae2-bb3b-1e23c24f129812025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8788AMITRIPTYLINE HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS INC.]1Current NDC, 5 package rows20241218_147d2f8f-842d-4f09-86b0-a66edce27778.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856853amitriptyline HCl 75 MG Oral TabletPSN147d2f8f-842d-4f09-86b0-a66edce277782
856853amitriptyline hydrochloride 75 MG Oral TabletSCD147d2f8f-842d-4f09-86b0-a66edce277782

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8788-168788878801100 TABLET in 1 BOTTLE (68788-8788-1) 100 tablet2024-12-16NoNoHistorical
68788-8788-36878887880330 TABLET in 1 BOTTLE (68788-8788-3) 30 tablet2024-12-16NoNoHistorical
68788-8788-66878887880660 TABLET in 1 BOTTLE (68788-8788-6) 60 tablet2024-12-16NoNoHistorical
68788-8788-86878887880828 TABLET in 1 BOTTLE (68788-8788-8) 28 tablet2024-12-16NoNoHistorical
68788-8788-96878887880990 TABLET in 1 BOTTLE (68788-8788-9) 90 tablet2024-12-16NoNoHistorical