Nortriptyline Hydrochloride

Product NDC
51655-507
11-digit product format
516550507
Labeler code
51655
Product ID
51655-507_490f8fd3-7543-fb69-e063-6294a90a8b21
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nortriptyline Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA075520
Marketing category
ANDA
Marketing start
2021-01-13
Substance
NORTRIPTYLINE HYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Tricyclic Antidepressant [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Nortriptyline Hydrochloride
Listing expiration
2027-12-31

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
51655-507-52Nortriptyline Hydrochloride30 in 1 BOTTLE, PLASTICCAPSULE302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-507NORTRIPTYLINE HYDROCHLORIDE CAPSULE [NORTHWIND PHARMACEUTICALS]1Current NDC, 1 package rows20230413_dae3314f-3128-787f-e053-2995a90aff19.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
317136nortriptyline HCl 25 MG Oral CapsulePSNdae3314f-3128-787f-e053-2995a90aff192
317136nortriptyline 25 MG Oral CapsuleSCDdae3314f-3128-787f-e053-2995a90aff192
317136nortriptyline (as nortriptyline HCl) 25 MG Oral CapsuleSYdae3314f-3128-787f-e053-2995a90aff192

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51655-507-525165505075230 CAPSULE in 1 BOTTLE, PLASTIC (51655-507-52) 30 capsule2021-01-13NoNoHistorical