Nortriptyline Hydrochloride

Product NDC
72888-157
11-digit product format
728880157
Labeler code
72888
Product ID
72888-157_47ca5d0b-0a49-87d1-e063-6394a90a1edb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nortriptyline Hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Advagen Pharma Ltd
Application
ANDA217731
Marketing category
ANDA
Marketing start
2022-06-14
Substance
NORTRIPTYLINE HYDROCHLORIDE
Active strength
10 mg/5mL
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 HYDROCHLORIDE10 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii00FN6IH15D
Rxcui312036

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
72888-157-39Nortriptyline Hydrochloride473 mL in 1 BOTTLESOLUTION4732

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72888-157NORTRIPTYLINE HYDROCHLORIDE SOLUTION [ADVAGEN PHARMA LTD]1Current NDC, 1 package rows20230923_bef9e24d-e730-4801-ab25-75e7d6bde225.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312036nortriptyline HCl 10 MG in 5 mL Oral SolutionPSNbef9e24d-e730-4801-ab25-75e7d6bde2252
312036nortriptyline 2 MG/ML Oral SolutionSCDbef9e24d-e730-4801-ab25-75e7d6bde2252
312036nortriptyline (as nortriptyline hydrochloride) 10 MG per 5 ML Oral SolutionSYbef9e24d-e730-4801-ab25-75e7d6bde2252
312036nortriptyline HCl 10 MG per 5 ML Oral SolutionSYbef9e24d-e730-4801-ab25-75e7d6bde2252
312036nortriptyline HCl 20 MG per 10 ML Oral SolutionSYbef9e24d-e730-4801-ab25-75e7d6bde2252

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72888-157-3972888015739473 mL in 1 BOTTLE (72888-157-39) 473 ml2022-06-14NoNoCurrent