FDA.reportPublic FDA data

Nortriptyline Hydrochloride

Product NDC
51862-016
11-digit product format
518620016
Labeler code
51862
Product ID
51862-016_912a2e7c-3615-4dff-b8b8-27eed882ab3f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nortriptyline Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Mayne Pharma Inc.
Application
ANDA073556
Marketing category
ANDA
Marketing start
2016-06-01
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
Rxcui198045, 198046, 198047, 317136

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51862-016-01Nortriptyline Hydrochloride100 in 1 BOTTLE, PLASTICCAPSULE1009
51862-016-05Nortriptyline Hydrochloride500 in 1 BOTTLE, PLASTICCAPSULE5009
51862-016-10Nortriptyline Hydrochloride1000 in 1 BOTTLE, PLASTICCAPSULE10009

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51862-016NORTRIPTYLINE HYDROCHLORIDE CAPSULE [MAYNE PHARMA INC.]9Current NDC, Legacy NDC, 3 package rows20210325_765d726b-fd4b-4ef7-afd7-9e7e9bf8cae6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
317136nortriptyline HCl 25 MG Oral CapsulePSNba4edb34-82ac-4c98-8abd-fd6176838c7816
317136nortriptyline 25 MG Oral CapsuleSCDba4edb34-82ac-4c98-8abd-fd6176838c7816
317136nortriptyline (as nortriptyline HCl) 25 MG Oral CapsuleSYba4edb34-82ac-4c98-8abd-fd6176838c7816
198045nortriptyline HCl 10 MG Oral CapsulePSN765d726b-fd4b-4ef7-afd7-9e7e9bf8cae69
317136nortriptyline HCl 25 MG Oral CapsulePSN765d726b-fd4b-4ef7-afd7-9e7e9bf8cae69
198046nortriptyline HCl 50 MG Oral CapsulePSN765d726b-fd4b-4ef7-afd7-9e7e9bf8cae69
198047nortriptyline HCl 75 MG Oral CapsulePSN765d726b-fd4b-4ef7-afd7-9e7e9bf8cae69
198045nortriptyline 10 MG Oral CapsuleSCD765d726b-fd4b-4ef7-afd7-9e7e9bf8cae69
317136nortriptyline 25 MG Oral CapsuleSCD765d726b-fd4b-4ef7-afd7-9e7e9bf8cae69
198046nortriptyline 50 MG Oral CapsuleSCD765d726b-fd4b-4ef7-afd7-9e7e9bf8cae69
198047nortriptyline 75 MG Oral CapsuleSCD765d726b-fd4b-4ef7-afd7-9e7e9bf8cae69
198045nortriptyline (as nortriptyline HCl) 10 MG Oral CapsuleSY765d726b-fd4b-4ef7-afd7-9e7e9bf8cae69
317136nortriptyline (as nortriptyline HCl) 25 MG Oral CapsuleSY765d726b-fd4b-4ef7-afd7-9e7e9bf8cae69
198046nortriptyline (as nortriptyline HCl) 50 MG Oral CapsuleSY765d726b-fd4b-4ef7-afd7-9e7e9bf8cae69
198047nortriptyline (as nortriptyline HCl) 75 MG Oral CapsuleSY765d726b-fd4b-4ef7-afd7-9e7e9bf8cae69

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51862-016-0151862001601100 CAPSULE in 1 BOTTLE, PLASTIC (51862-016-01) 100 capsule2016-06-012021-04-30NoNoCurrent
51862-016-0551862001605500 CAPSULE in 1 BOTTLE, PLASTIC (51862-016-05) 500 capsule2016-06-010000-00-00NoNoCurrent
51862-016-10518620016101000 CAPSULE in 1 BOTTLE, PLASTIC (51862-016-10) 1000 capsule2016-06-010000-00-00NoNoCurrent