Amitriptyline Hydrochloride

Product NDC
60760-556
11-digit product format
607600556
Labeler code
60760
Product ID
60760-556_450e40f4-fa23-ad42-e063-6294a90ac458
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amitriptyline Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
ST. MARY'S MEDICAL PARK PHARMACY
Application
ANDA214548
Marketing category
ANDA
Marketing start
2022-07-13
Substance
AMITRIPTYLINE HYDROCHLORIDE
Active strength
10 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 HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii26LUD4JO9K
Rxcui856783

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
60760-556-15Amitriptyline Hydrochloride15 in 1 BOTTLE, PLASTICTABLET, FILM COATED153
60760-556-90Amitriptyline Hydrochloride90 in 1 BOTTLE, PLASTICTABLET, FILM COATED903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60760-556-15EA - Each60760-556774f428e-2170-465f-a6bf-1608a3c4320012022-08-04
60760-556-90EA - Each60760-5564ea283a0-615c-4c48-a523-140cfd65846812025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60760-556AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [ST. MARY'S MEDICAL PARK PHARMACY]2Current NDC, Legacy NDC, 2 package rows20250515_e3dd745a-57f5-4925-e053-2995a90a43c0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856783amitriptyline HCl 10 MG Oral TabletPSNe3dd745a-57f5-4925-e053-2995a90a43c03
856783amitriptyline hydrochloride 10 MG Oral TabletSCDe3dd745a-57f5-4925-e053-2995a90a43c03

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60760-556-156076005561515 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-556-15) 2022-07-130000-00-00NoNoCurrent
60760-556-906076005569090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-556-90) 2025-05-13NoNoCurrent