FDA.reportPublic FDA data

Nortriptyline Hydrochloride

Product NDC
51862-017
11-digit product format
518620017
Labeler code
51862
Product ID
51862-017_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
Marketing end
2021-03-31
Substance
NORTRIPTYLINE HYDROCHLORIDE
Active strength
50 mg/1
Pharmacologic classes
Tricyclic Antidepressant [EPC]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

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
51862-017-01Nortriptyline Hydrochloride100 in 1 BOTTLE, PLASTICCAPSULE1009
51862-017-05Nortriptyline Hydrochloride500 in 1 BOTTLE, PLASTICCAPSULE5009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51862-017-01EA - Each51862-0179d409c57-86c5-4f56-9a02-bdf005695c8812016-09-02
51862-017-05EA - Each51862-01727b9421f-7f15-4b67-a404-ca3ee6112d1512016-09-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51862-017NORTRIPTYLINE HYDROCHLORIDE CAPSULE [MAYNE PHARMA INC.]9Legacy NDC, 2 package rows20210325_765d726b-fd4b-4ef7-afd7-9e7e9bf8cae6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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
317136nortriptyline HCl 25 MG Oral CapsulePSN8024d787-333d-1235-e053-2991aa0a7e4c2
198046nortriptyline HCl 50 MG Oral CapsulePSN8024d787-333d-1235-e053-2991aa0a7e4c2
317136nortriptyline 25 MG Oral CapsuleSCD8024d787-333d-1235-e053-2991aa0a7e4c2
198046nortriptyline 50 MG Oral CapsuleSCD8024d787-333d-1235-e053-2991aa0a7e4c2
317136nortriptyline (as nortriptyline HCl) 25 MG Oral CapsuleSY8024d787-333d-1235-e053-2991aa0a7e4c2
198046nortriptyline (as nortriptyline HCl) 50 MG Oral CapsuleSY8024d787-333d-1235-e053-2991aa0a7e4c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51862-017-0151862001701100 CAPSULE in 1 BOTTLE, PLASTIC (51862-017-01) 100 capsule2016-06-010000-00-00NoNoCurrent
51862-017-0551862001705500 CAPSULE in 1 BOTTLE, PLASTIC (51862-017-05) 500 capsule2016-06-012021-03-31NoNoCurrent