Nortriptyline Hydrochloride

Product NDC
63187-759
11-digit product format
631870759
Labeler code
63187
Product ID
63187-759_fea5a7b8-46bd-4de4-bc33-5445036d0fe9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nortriptyline Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA074132
Marketing category
ANDA
Marketing start
1995-04-05
Substance
NORTRIPTYLINE HYDROCHLORIDE
Active strength
50 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 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
53e88688-54e1-9681-22b8-e499bd715088Product name220210729

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63187-759-30Nortriptyline Hydrochloride30 in 1 BOTTLECAPSULE307
63187-759-60Nortriptyline Hydrochloride60 in 1 BOTTLECAPSULE607
63187-759-90Nortriptyline Hydrochloride90 in 1 BOTTLECAPSULE907

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-759-60EA - Each63187-7593f323768-c7a9-45c9-bf58-164512777aab12023-04-07
63187-759-90EA - Each63187-759d13fad16-f65a-4e61-b45c-1726e91bd60412019-06-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-759NORTRIPTYLINE HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]7Current NDC, Legacy NDC, 3 package rows20241024_b387ba49-fd3f-4488-86e8-9b81e85ab232.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198046nortriptyline HCl 50 MG Oral CapsulePSNb387ba49-fd3f-4488-86e8-9b81e85ab2327
198046nortriptyline 50 MG Oral CapsuleSCDb387ba49-fd3f-4488-86e8-9b81e85ab2327
198046nortriptyline (as nortriptyline HCl) 50 MG Oral CapsuleSYb387ba49-fd3f-4488-86e8-9b81e85ab2327

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-759-306318707593030 CAPSULE in 1 BOTTLE (63187-759-30) 30 capsule2016-10-030000-00-00NoNoCurrent
63187-759-606318707596060 CAPSULE in 1 BOTTLE (63187-759-60) 60 capsule2016-10-030000-00-00NoNoCurrent
63187-759-906318707599090 CAPSULE in 1 BOTTLE (63187-759-90) 90 capsule2016-10-030000-00-00NoNoCurrent