FDA.reportPublic FDA data

Nortriptyline HCL

Product NDC
72189-561
11-digit product format
721890561
Labeler code
72189
Product ID
72189-561_4f80f438-f78e-6d65-e063-6394a90a6c1e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nortriptyline HCL
Dosage form
CAPSULE
Route
ORAL
Labeler
Direct_rx
Application
ANDA073556
Marketing category
ANDA
Marketing start
2024-06-20
Substance
NORTRIPTYLINE HYDROCHLORIDE
Active strength
25 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 HYDROCHLORIDE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii00FN6IH15D
Rxcui317136

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
72189-561-30Nortriptyline HCL30 in 1 BOTTLECAPSULE304
72189-561-60Nortriptyline HCL60 in 1 BOTTLECAPSULE604
72189-561-90Nortriptyline HCL90 in 1 BOTTLECAPSULE904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-561-30EA - Each72189-5613062ecee-d194-4bf5-b954-17871d4d223f12024-09-09
72189-561-60EA - Each72189-561a0365973-ba91-4747-a9c7-f395666db72412025-09-12
72189-561-90EA - Each72189-561e6cc9d2a-9e62-40b9-bed3-4daa802e186a12024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-561NORTRIPTYLINE HCL CAPSULE [DIRECT_RX]2Current NDC, 3 package rows20240829_1b55fd23-36f8-10e4-e063-6394a90aa49a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
317136nortriptyline HCl 25 MG Oral CapsulePSN1b55fd23-36f8-10e4-e063-6394a90aa49a4
317136nortriptyline 25 MG Oral CapsuleSCD1b55fd23-36f8-10e4-e063-6394a90aa49a4
317136nortriptyline (as nortriptyline HCl) 25 MG Oral CapsuleSY1b55fd23-36f8-10e4-e063-6394a90aa49a4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72189-561-307218905613030 CAPSULE in 1 BOTTLE (72189-561-30) 30 capsule2024-06-20NoNoCurrent
72189-561-607218905616060 CAPSULE in 1 BOTTLE (72189-561-60) 60 capsule2024-06-20NoNoCurrent
72189-561-907218905619090 CAPSULE in 1 BOTTLE (72189-561-90) 90 capsule2024-06-20NoNoCurrent