FDA.reportPublic FDA data

Nortriptyline Hydrochloride

Product NDC
63187-715
11-digit product format
631870715
Labeler code
63187
Product ID
63187-715_ab58250b-3975-4411-96c5-870e0de04c5c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nortriptyline Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA075520
Marketing category
ANDA
Marketing start
2000-05-08
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
63187-715-30Nortriptyline Hydrochloride30 in 1 BOTTLECAPSULE304
63187-715-60Nortriptyline Hydrochloride60 in 1 BOTTLECAPSULE604
63187-715-90Nortriptyline Hydrochloride90 in 1 BOTTLECAPSULE904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-715-30EA - Each63187-715e0d158ea-9efc-48e6-9265-495accb8bad612020-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-715NORTRIPTYLINE HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]4Current NDC, Legacy NDC, 3 package rows20230124_70921f99-1f25-4a8c-8269-6d5d26be7a63.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198045nortriptyline HCl 10 MG Oral CapsulePSN70921f99-1f25-4a8c-8269-6d5d26be7a634
198045nortriptyline 10 MG Oral CapsuleSCD70921f99-1f25-4a8c-8269-6d5d26be7a634
198045nortriptyline (as nortriptyline HCl) 10 MG Oral CapsuleSY70921f99-1f25-4a8c-8269-6d5d26be7a634

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-715-306318707153030 CAPSULE in 1 BOTTLE (63187-715-30) 30 capsule2016-06-010000-00-00NoNoCurrent
63187-715-606318707156060 CAPSULE in 1 BOTTLE (63187-715-60) 60 capsule2016-06-010000-00-00NoNoCurrent
63187-715-906318707159090 CAPSULE in 1 BOTTLE (63187-715-90) 90 capsule2016-06-010000-00-00NoNoCurrent