Nortriptyline Hydrochloride

Product NDC
51862-947
11-digit product format
518620947
Labeler code
51862
Product ID
51862-947_a7804223-4fad-40cf-96c1-c3ee2cbd1fd1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nortriptyline Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Mayne Pharma Inc.
Application
ANDA073556
Marketing category
ANDA
Marketing start
2019-12-12
Marketing end
0000-00-00
Substance
NORTRIPTYLINE HYDROCHLORIDE
Active strength
50 mg/1
Pharmacologic classes
Tricyclic Antidepressant [EPC]
NDC exclude flag
No
Listing certified through
2021-12-31
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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51862-947-01EA - Each51862-947833978ff-5cf0-4f61-8469-3a8be15d671e12020-03-10
51862-947-05EA - Each51862-947e4e824a1-9a67-4b7c-9278-2934e5cee06412020-03-10

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198046nortriptyline HCl 50 MG Oral CapsulePSNbae90e1e-0b14-6e0e-e053-2a95a90af54e1
198046nortriptyline 50 MG Oral CapsuleSCDbae90e1e-0b14-6e0e-e053-2a95a90af54e1
198046nortriptyline (as nortriptyline HCl) 50 MG Oral CapsuleSYbae90e1e-0b14-6e0e-e053-2a95a90af54e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51862-947-0151862094701100 CAPSULE in 1 BOTTLE, PLASTIC (51862-947-01) 100 capsule2019-12-120000-00-00NoNoCurrent
51862-947-0551862094705500 CAPSULE in 1 BOTTLE, PLASTIC (51862-947-05) 500 capsule2019-12-120000-00-00NoNoCurrent