Nortriptyline Hydrochloride

Product NDC
70518-4122
11-digit product format
705184122
Labeler code
70518
Product ID
70518-4122_3fa55d9e-0149-4333-e063-6394a90a39f5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nortriptyline Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA073556
Marketing category
ANDA
Marketing start
2024-06-28
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-4122-0Nortriptyline Hydrochloride30 in 1 BLISTER PACKCAPSULE303
70518-4122-1Nortriptyline Hydrochloride30 in 1 BLISTER PACKCAPSULE303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-4122NORTRIPTYLINE HYDROCHLORIDE CAPSULE [REMEDYREPACK INC.]2Current NDC, 2 package rows20250305_c7cce83f-9508-49de-a442-246ad18ddeda.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198046nortriptyline HCl 50 MG Oral CapsulePSNc7cce83f-9508-49de-a442-246ad18ddeda3
198046nortriptyline 50 MG Oral CapsuleSCDc7cce83f-9508-49de-a442-246ad18ddeda3
198046nortriptyline (as nortriptyline HCl) 50 MG Oral CapsuleSYc7cce83f-9508-49de-a442-246ad18ddeda3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-4122-07051841220030 CAPSULE in 1 BLISTER PACK (70518-4122-0) 30 capsule2024-06-28NoNoHistorical
70518-4122-17051841220130 CAPSULE in 1 BLISTER PACK (70518-4122-1) 30 capsule2025-03-03NoNoHistorical