FDA.reportPublic FDA data

Nortriptyline Hydrochloride

Product NDC
71335-0426
11-digit product format
713350426
Labeler code
71335
Product ID
71335-0426_1c7ab195-2d22-4021-9af0-f77317695c7c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nortriptyline Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA075520
Marketing category
ANDA
Marketing start
2000-05-08
Substance
NORTRIPTYLINE HYDROCHLORIDE
Active strength
10 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 HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii00FN6IH15D
Rxcui198045, 198046, 198047, 317136

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
71335-0426-1Nortriptyline Hydrochloride30 in 1 BOTTLECAPSULE3016
71335-0426-2Nortriptyline Hydrochloride60 in 1 BOTTLECAPSULE6016
71335-0426-3Nortriptyline Hydrochloride90 in 1 BOTTLECAPSULE9016
71335-0426-4Nortriptyline Hydrochloride100 in 1 BOTTLECAPSULE10016
71335-0426-5Nortriptyline Hydrochloride120 in 1 BOTTLECAPSULE12016
71335-0426-6Nortriptyline Hydrochloride15 in 1 BOTTLECAPSULE1516

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0426NORTRIPTYLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]16Current NDC, Legacy NDC, 6 package rows20231025_cb4d1a69-60ae-4fdc-8af8-059959cf7265.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198045nortriptyline HCl 10 MG Oral CapsulePSNcb4d1a69-60ae-4fdc-8af8-059959cf726516
317136nortriptyline HCl 25 MG Oral CapsulePSNcb4d1a69-60ae-4fdc-8af8-059959cf726516
198046nortriptyline HCl 50 MG Oral CapsulePSNcb4d1a69-60ae-4fdc-8af8-059959cf726516
198047nortriptyline HCl 75 MG Oral CapsulePSNcb4d1a69-60ae-4fdc-8af8-059959cf726516
198045nortriptyline 10 MG Oral CapsuleSCDcb4d1a69-60ae-4fdc-8af8-059959cf726516
317136nortriptyline 25 MG Oral CapsuleSCDcb4d1a69-60ae-4fdc-8af8-059959cf726516
198046nortriptyline 50 MG Oral CapsuleSCDcb4d1a69-60ae-4fdc-8af8-059959cf726516
198047nortriptyline 75 MG Oral CapsuleSCDcb4d1a69-60ae-4fdc-8af8-059959cf726516
198045nortriptyline (as nortriptyline HCl) 10 MG Oral CapsuleSYcb4d1a69-60ae-4fdc-8af8-059959cf726516
317136nortriptyline (as nortriptyline HCl) 25 MG Oral CapsuleSYcb4d1a69-60ae-4fdc-8af8-059959cf726516
198046nortriptyline (as nortriptyline HCl) 50 MG Oral CapsuleSYcb4d1a69-60ae-4fdc-8af8-059959cf726516
198047nortriptyline (as nortriptyline HCl) 75 MG Oral CapsuleSYcb4d1a69-60ae-4fdc-8af8-059959cf726516

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0426-17133504260130 CAPSULE in 1 BOTTLE (71335-0426-1) 30 capsule2015-04-290000-00-00NoNoCurrent
71335-0426-27133504260260 CAPSULE in 1 BOTTLE (71335-0426-2) 60 capsule2015-04-290000-00-00NoNoCurrent
71335-0426-37133504260390 CAPSULE in 1 BOTTLE (71335-0426-3) 90 capsule2015-04-290000-00-00NoNoCurrent
71335-0426-471335042604100 CAPSULE in 1 BOTTLE (71335-0426-4) 100 capsule2015-04-290000-00-00NoNoCurrent
71335-0426-571335042605120 CAPSULE in 1 BOTTLE (71335-0426-5) 120 capsule2015-04-290000-00-00NoNoCurrent
71335-0426-67133504260615 CAPSULE in 1 BOTTLE (71335-0426-6) 15 capsule2015-04-290000-00-00NoNoCurrent