Nortriptyline HCL

Product NDC
72189-563
11-digit product format
721890563
Labeler code
72189
Product ID
72189-563_4d3a9c67-ae9c-d4c1-e063-6394a90aff1f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nortriptyline HCL
Dosage form
CAPSULE
Route
ORAL
Labeler
Direct_rx
Application
ANDA073556
Marketing category
ANDA
Marketing start
2024-06-26
Substance
NORTRIPTYLINE HYDROCHLORIDE
Active strength
10 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 HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii00FN6IH15D
Rxcui198045

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
72189-563-30Nortriptyline HCL30 in 1 BOTTLE, PLASTICCAPSULE302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-563NORTRIPTYLINE HCL CAPSULE [DIRECT_RX]1Current NDC, 1 package rows20240628_1bcf2f7b-974f-54ad-e063-6394a90a28d9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198045nortriptyline HCl 10 MG Oral CapsulePSN1bcf2f7b-974f-54ad-e063-6394a90a28d92
198045nortriptyline 10 MG Oral CapsuleSCD1bcf2f7b-974f-54ad-e063-6394a90a28d92
198045nortriptyline (as nortriptyline HCl) 10 MG Oral CapsuleSY1bcf2f7b-974f-54ad-e063-6394a90a28d92

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72189-563-307218905633030 CAPSULE in 1 BOTTLE, PLASTIC (72189-563-30) 30 capsule2024-06-26NoNoCurrent