FDA.reportPublic FDA data

Nortriptyline Hydrochloride

Product NDC
76420-913
11-digit product format
764200913
Labeler code
76420
Product ID
76420-913_2cbda9e6-b8cc-1364-e063-6294a90ace66
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nortriptyline Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Asclemed USA, Inc.
Application
ANDA073556
Marketing category
ANDA
Marketing start
2023-11-17
Substance
NORTRIPTYLINE HYDROCHLORIDE
Active strength
75 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
Nortriptyline Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NORTRIPTYLINE HYDROCHLORIDE75 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii00FN6IH15D
Rxcui198045, 198046, 198047, 317136

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
de76de11-1019-6138-2d8a-16fa566ae22aProduct name220241009
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
53e88688-54e1-9681-22b8-e499bd715088Product name220210729

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76420-913-01Nortriptyline Hydrochloride100 in 1 BOTTLE, PLASTICCAPSULE1001
76420-913-30Nortriptyline Hydrochloride30 in 1 BOTTLE, PLASTICCAPSULE301
76420-913-60Nortriptyline Hydrochloride60 in 1 BOTTLE, PLASTICCAPSULE601
76420-913-90Nortriptyline Hydrochloride90 in 1 BOTTLE, PLASTICCAPSULE901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-913NORTRIPTYLINE HYDROCHLORIDE CAPSULE [ASCLEMED USA, INC.]1Current NDC, 4 package rows20250130_b02eb04a-83ee-45b0-b755-187fde2698c3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198045nortriptyline HCl 10 MG Oral CapsulePSNb02eb04a-83ee-45b0-b755-187fde2698c31
317136nortriptyline HCl 25 MG Oral CapsulePSNb02eb04a-83ee-45b0-b755-187fde2698c31
198046nortriptyline HCl 50 MG Oral CapsulePSNb02eb04a-83ee-45b0-b755-187fde2698c31
198047nortriptyline HCl 75 MG Oral CapsulePSNb02eb04a-83ee-45b0-b755-187fde2698c31
198045nortriptyline 10 MG Oral CapsuleSCDb02eb04a-83ee-45b0-b755-187fde2698c31
317136nortriptyline 25 MG Oral CapsuleSCDb02eb04a-83ee-45b0-b755-187fde2698c31
198046nortriptyline 50 MG Oral CapsuleSCDb02eb04a-83ee-45b0-b755-187fde2698c31
198047nortriptyline 75 MG Oral CapsuleSCDb02eb04a-83ee-45b0-b755-187fde2698c31
198045nortriptyline (as nortriptyline HCl) 10 MG Oral CapsuleSYb02eb04a-83ee-45b0-b755-187fde2698c31
317136nortriptyline (as nortriptyline HCl) 25 MG Oral CapsuleSYb02eb04a-83ee-45b0-b755-187fde2698c31
198046nortriptyline (as nortriptyline HCl) 50 MG Oral CapsuleSYb02eb04a-83ee-45b0-b755-187fde2698c31
198047nortriptyline (as nortriptyline HCl) 75 MG Oral CapsuleSYb02eb04a-83ee-45b0-b755-187fde2698c31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76420-913-0176420091301100 CAPSULE in 1 BOTTLE, PLASTIC (76420-913-01) 100 capsule2025-01-28NoNoHistorical
76420-913-307642009133030 CAPSULE in 1 BOTTLE, PLASTIC (76420-913-30) 30 capsule2025-01-28NoNoHistorical
76420-913-607642009136060 CAPSULE in 1 BOTTLE, PLASTIC (76420-913-60) 60 capsule2025-01-28NoNoHistorical
76420-913-907642009139090 CAPSULE in 1 BOTTLE, PLASTIC (76420-913-90) 90 capsule2025-01-28NoNoHistorical