FDA.reportPublic FDA data

Amitriptyline Hydrochloride

Product NDC
68788-8767
11-digit product format
687888767
Labeler code
68788
Product ID
68788-8767_f7ae98ac-21aa-41bb-bbb3-6145e02dd370
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amitriptyline Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA217411
Marketing category
ANDA
Marketing start
2024-11-20
Substance
AMITRIPTYLINE HYDROCHLORIDE
Active strength
50 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 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
68788-8767-3Amitriptyline Hydrochloride30 in 1 BOTTLETABLET302
68788-8767-6Amitriptyline Hydrochloride60 in 1 BOTTLETABLET602
68788-8767-8Amitriptyline Hydrochloride28 in 1 BOTTLETABLET282
68788-8767-9Amitriptyline Hydrochloride90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8767-3EA - Each68788-8767a80aefea-1ebb-4ad3-84df-bbe68379f84b12025-01-14
68788-8767-6EA - Each68788-87672cf46b26-231b-4a39-be76-fbba17f546e412025-01-14
68788-8767-8EA - Each68788-876784f06057-4393-48e9-9bfa-27cad764e06612025-01-14
68788-8767-9EA - Each68788-8767437aa6e5-0d8c-4dd6-bab9-b84a65bf6a8112025-01-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8767AMITRIPTYLINE HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS INC.]1Current NDC, 4 package rows20241122_54485767-d7c5-4927-ae52-08537a7a91e8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856845amitriptyline HCl 50 MG Oral TabletPSN54485767-d7c5-4927-ae52-08537a7a91e82
856845amitriptyline hydrochloride 50 MG Oral TabletSCD54485767-d7c5-4927-ae52-08537a7a91e82

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8767-36878887670330 TABLET in 1 BOTTLE (68788-8767-3) 30 tablet2024-11-20NoNoHistorical
68788-8767-66878887670660 TABLET in 1 BOTTLE (68788-8767-6) 60 tablet2024-11-20NoNoHistorical
68788-8767-86878887670828 TABLET in 1 BOTTLE (68788-8767-8) 28 tablet2024-11-20NoNoHistorical
68788-8767-96878887670990 TABLET in 1 BOTTLE (68788-8767-9) 90 tablet2024-11-20NoNoHistorical