Nortriptyline Hydrochloride

Product NDC
67544-078
11-digit product format
675440078
Labeler code
67544
Product ID
67544-078_00c8012b-9b3c-44b9-8f0e-be0b6cef2bec
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nortriptyline Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA074132
Marketing category
ANDA
Marketing start
1995-04-06
Marketing end
0000-00-00
Substance
NORTRIPTYLINE HYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Tricyclic Antidepressant [EPC]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
de76de11-1019-6138-2d8a-16fa566ae22aProduct name220241009
53e88688-54e1-9681-22b8-e499bd715088Product name220210729

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67544-078-30Nortriptyline Hydrochloride30 in 1 BOTTLE, PLASTICCAPSULE303
67544-078-53Nortriptyline Hydrochloride60 in 1 BOTTLE, PLASTICCAPSULE603
67544-078-60Nortriptyline Hydrochloride90 in 1 BOTTLE, PLASTICCAPSULE903
67544-078-70Nortriptyline Hydrochloride120 in 1 BOTTLE, PLASTICCAPSULE1203
67544-078-80Nortriptyline Hydrochloride180 in 1 BOTTLE, PLASTICCAPSULE1803
67544-078-92Nortriptyline Hydrochloride270 in 1 BOTTLE, PLASTICCAPSULE2703
67544-078-94Nortriptyline Hydrochloride360 in 1 BOTTLE, PLASTICCAPSULE3603

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67544-078NORTRIPTYLINE HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]3Legacy NDC, 7 package rows20191224_e1f5e650-e83f-4343-a025-fc90f645a796.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
317136nortriptyline HCl 25 MG Oral CapsulePSNe1f5e650-e83f-4343-a025-fc90f645a7963
317136nortriptyline 25 MG Oral CapsuleSCDe1f5e650-e83f-4343-a025-fc90f645a7963
317136nortriptyline (as nortriptyline HCl) 25 MG Oral CapsuleSYe1f5e650-e83f-4343-a025-fc90f645a7963

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67544-078-306754400783030 CAPSULE in 1 BOTTLE, PLASTIC (67544-078-30) 30 capsule2004-06-260000-00-00NoNoCurrent
67544-078-536754400785360 CAPSULE in 1 BOTTLE, PLASTIC (67544-078-53) 60 capsule2004-06-120000-00-00NoNoCurrent
67544-078-606754400786090 CAPSULE in 1 BOTTLE, PLASTIC (67544-078-60) 90 capsule2004-06-120000-00-00NoNoCurrent
67544-078-7067544007870120 CAPSULE in 1 BOTTLE, PLASTIC (67544-078-70) 120 capsule2009-02-230000-00-00NoNoCurrent
67544-078-8067544007880180 CAPSULE in 1 BOTTLE, PLASTIC (67544-078-80) 180 capsule2009-02-230000-00-00NoNoCurrent
67544-078-9267544007892270 CAPSULE in 1 BOTTLE, PLASTIC (67544-078-92) 270 capsule2006-08-170000-00-00NoNoCurrent
67544-078-9467544007894360 CAPSULE in 1 BOTTLE, PLASTIC (67544-078-94) 360 capsule2006-08-170000-00-00NoNoCurrent