Amitriptyline Hydrochloride

Product NDC
60760-685
11-digit product format
607600685
Labeler code
60760
Product ID
60760-685_35a6fab2-4bf5-22e1-e063-6394a90afe12
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amitriptyline Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
ST. MARY'S MEDICAL PARK PHARMACY
Application
ANDA217411
Marketing category
ANDA
Marketing start
2023-06-10
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
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
60760-685-90Amitriptyline Hydrochloride90 in 1 BOTTLE, PLASTICTABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60760-685-90EA - Each60760-68596e6e119-135c-4639-a66b-584c1fe67f5612025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60760-685AMITRIPTYLINE HYDROCHLORIDE TABLET [ST. MARY'S MEDICAL PARK PHARMACY]1Current NDC, 1 package rows20250523_35a6e911-507a-ef0d-e063-6294a90a07e1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856834amitriptyline HCl 25 MG Oral TabletPSN35a6e911-507a-ef0d-e063-6294a90a07e11
856834amitriptyline hydrochloride 25 MG Oral TabletSCD35a6e911-507a-ef0d-e063-6294a90a07e11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
60760-685-906076006859090 TABLET in 1 BOTTLE, PLASTIC (60760-685-90) 90 tablet2025-05-13NoNoHistorical