Nortriptyline Hydrochloride

Product NDC
70518-3920
11-digit product format
705183920
Labeler code
70518
Product ID
70518-3920_3ba347e0-d74e-af63-e063-6394a90ae90f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nortriptyline Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA074132
Marketing category
ANDA
Marketing start
2023-11-21
Substance
NORTRIPTYLINE 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
Nortriptyline Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NORTRIPTYLINE HYDROCHLORIDE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii00FN6IH15D
Rxcui317136

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
de76de11-1019-6138-2d8a-16fa566ae22aProduct name220241009
53e88688-54e1-9681-22b8-e499bd715088Product name220210729

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-3920-0Nortriptyline Hydrochloride30 in 1 BLISTER PACKCAPSULE304
70518-3920-1Nortriptyline Hydrochloride30 in 1 BOTTLE, PLASTICCAPSULE304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3920NORTRIPTYLINE HYDROCHLORIDE CAPSULE [REMEDYREPACK INC.]2Current NDC, 2 package rows20240404_522d0cd8-d84d-4961-a525-4527fce44c3c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
317136nortriptyline HCl 25 MG Oral CapsulePSN522d0cd8-d84d-4961-a525-4527fce44c3c4
317136nortriptyline 25 MG Oral CapsuleSCD522d0cd8-d84d-4961-a525-4527fce44c3c4
317136nortriptyline (as nortriptyline HCl) 25 MG Oral CapsuleSY522d0cd8-d84d-4961-a525-4527fce44c3c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-3920-07051839200030 in 1 BLISTER PACKHistorical
70518-3920-17051839200130 CAPSULE in 1 BOTTLE, PLASTIC (70518-3920-1) 30 capsule2025-06-18NoNoHistorical