FDA.reportPublic FDA data

Nortriptyline Hydrochloride

Product NDC
71335-2351
11-digit product format
713352351
Labeler code
71335
Product ID
71335-2351_ca950abc-d73c-4eec-babf-4c79c8a9defc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nortriptyline Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA073556
Marketing category
ANDA
Marketing start
2023-11-17
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
71335-2351-1Nortriptyline Hydrochloride30 in 1 BOTTLE, PLASTICCAPSULE30100
71335-2351-2Nortriptyline Hydrochloride60 in 1 BOTTLE, PLASTICCAPSULE60100
71335-2351-3Nortriptyline Hydrochloride90 in 1 BOTTLE, PLASTICCAPSULE90100
71335-2351-4Nortriptyline Hydrochloride28 in 1 BOTTLE, PLASTICCAPSULE28100
71335-2351-5Nortriptyline Hydrochloride120 in 1 BOTTLE, PLASTICCAPSULE120100

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2351NORTRIPTYLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]100Current NDC, 5 package rows20240223_4442f029-dd5e-4834-9b01-eb8c638ce4b1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198046nortriptyline HCl 50 MG Oral CapsulePSN4442f029-dd5e-4834-9b01-eb8c638ce4b1100
198046nortriptyline 50 MG Oral CapsuleSCD4442f029-dd5e-4834-9b01-eb8c638ce4b1100
198046nortriptyline (as nortriptyline HCl) 50 MG Oral CapsuleSY4442f029-dd5e-4834-9b01-eb8c638ce4b1100

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2351-17133523510130 CAPSULE in 1 BOTTLE, PLASTIC (71335-2351-1) 30 capsule2024-02-21NoNoCurrent
71335-2351-27133523510260 CAPSULE in 1 BOTTLE, PLASTIC (71335-2351-2) 60 capsule2024-02-21NoNoCurrent
71335-2351-37133523510390 CAPSULE in 1 BOTTLE, PLASTIC (71335-2351-3) 90 capsule2024-02-21NoNoCurrent
71335-2351-47133523510428 CAPSULE in 1 BOTTLE, PLASTIC (71335-2351-4) 28 capsule2024-02-21NoNoCurrent
71335-2351-571335235105120 CAPSULE in 1 BOTTLE, PLASTIC (71335-2351-5) 120 capsule2024-02-21NoNoCurrent