FDA.reportPublic FDA data

Nortriptyline Hydrochloride

Product NDC
50090-7174
11-digit product format
500907174
Labeler code
50090
Product ID
50090-7174_d965809c-57f8-4879-b4df-c119c672d60c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nortriptyline Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA074132
Marketing category
ANDA
Marketing start
1995-04-05
Substance
NORTRIPTYLINE HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Tricyclic Antidepressant [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Nortriptyline Hydrochloride
Listing expiration
2026-12-31

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
53e88688-54e1-9681-22b8-e499bd715088Product name220210729

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-7174-0Nortriptyline Hydrochloride60 in 1 BOTTLECAPSULE603
50090-7174-1Nortriptyline Hydrochloride30 in 1 BOTTLECAPSULE303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7174-0EA - Each50090-7174c6e6ecb3-d6cf-4265-b0a0-e8fc13aa413812024-07-12
50090-7174-1EA - Each50090-7174123eee02-5fd3-4421-89fe-41fed6516c0e12024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-7174NORTRIPTYLINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS]1Current NDC, 2 package rows20240613_686d15d0-6434-42ec-8c78-f45d617d294c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198045nortriptyline HCl 10 MG Oral CapsulePSN686d15d0-6434-42ec-8c78-f45d617d294c3
198045nortriptyline 10 MG Oral CapsuleSCD686d15d0-6434-42ec-8c78-f45d617d294c3
198045nortriptyline (as nortriptyline HCl) 10 MG Oral CapsuleSY686d15d0-6434-42ec-8c78-f45d617d294c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-7174-05009071740060 CAPSULE in 1 BOTTLE (50090-7174-0) 60 capsule2024-05-23NoNoCurrent
50090-7174-15009071740130 CAPSULE in 1 BOTTLE (50090-7174-1) 30 capsule2024-05-23NoNoCurrent