Nortriptyline Hydrochloride

Product NDC
67046-1530
11-digit product format
670461530
Labeler code
67046
Product ID
67046-1530_2fffe23d-37c8-34fe-e063-6294a90a7b6c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nortriptyline Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Coupler LLC
Application
ANDA073556
Marketing category
ANDA
Marketing start
2025-03-10
Substance
NORTRIPTYLINE HYDROCHLORIDE
Active strength
50 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 HYDROCHLORIDE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii00FN6IH15D
Rxcui198046

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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67046-1530-3Nortriptyline Hydrochloride30 in 1 BLISTER PACKCAPSULE301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-1530NORTRIPTYLINE HYDROCHLORIDE CAPSULE [COUPLER LLC]1Current NDC, 1 package rows20250311_2fffe23d-37f8-34fe-e063-6294a90a7b6c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198046nortriptyline HCl 50 MG Oral CapsulePSN2fffe23d-37f8-34fe-e063-6294a90a7b6c1
198046nortriptyline 50 MG Oral CapsuleSCD2fffe23d-37f8-34fe-e063-6294a90a7b6c1
198046nortriptyline (as nortriptyline HCl) 50 MG Oral CapsuleSY2fffe23d-37f8-34fe-e063-6294a90a7b6c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
67046-1530-36704615300330 CAPSULE in 1 BLISTER PACK (67046-1530-3) 30 capsule2025-03-10NoNoHistorical