FDA.reportPublic FDA data

Nortriptyline HCL

Product NDC
72189-562
11-digit product format
721890562
Labeler code
72189
Product ID
72189-562_4d3a9c62-805e-df8c-e063-6294a90aa498
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nortriptyline HCL
Dosage form
CAPSULE
Route
ORAL
Labeler
Direct_rx
Application
ANDA073556
Marketing category
ANDA
Marketing start
2024-06-24
Substance
NORTRIPTYLINE HYDROCHLORIDE
Active strength
50 mg/1
Pharmacologic classes
Tricyclic Antidepressant [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Nortriptyline HCL
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NORTRIPTYLINE HYDROCHLORIDE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii00FN6IH15D
Rxcui198046

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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72189-562-30Nortriptyline HCL30 in 1 BOTTLE, PLASTICCAPSULE303
72189-562-60Nortriptyline HCL60 in 1 BOTTLECAPSULE603

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-562-30EA - Each72189-562a1340546-d141-46fc-a714-2d2eed80a93012024-07-12
72189-562-60EA - Each72189-5625cddf8cb-988e-491a-9ada-57e756f184c712024-09-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-562NORTRIPTYLINE HCL CAPSULE [DIRECT_RX]2Current NDC, 2 package rows20240809_1ba55931-5597-90ea-e063-6294a90a5a2f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198046nortriptyline HCl 50 MG Oral CapsulePSN1ba55931-5597-90ea-e063-6294a90a5a2f3
198046nortriptyline 50 MG Oral CapsuleSCD1ba55931-5597-90ea-e063-6294a90a5a2f3
198046nortriptyline (as nortriptyline HCl) 50 MG Oral CapsuleSY1ba55931-5597-90ea-e063-6294a90a5a2f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72189-562-307218905623030 CAPSULE in 1 BOTTLE, PLASTIC (72189-562-30) 30 capsule2024-06-24NoNoHistorical
72189-562-607218905626060 CAPSULE in 1 BOTTLE (72189-562-60) 60 capsule2024-06-24NoNoHistorical