Nortriptyline Hydrochloride

Product NDC
63187-396
11-digit product format
631870396
Labeler code
63187
Product ID
63187-396_18775e95-6eef-4cec-bf3f-3a9d5e8550d1
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
25 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 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
53e88688-54e1-9681-22b8-e499bd715088Product name220210729

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63187-396-30Nortriptyline Hydrochloride30 in 1 BOTTLECAPSULE305
63187-396-60Nortriptyline Hydrochloride60 in 1 BOTTLECAPSULE605
63187-396-90Nortriptyline Hydrochloride90 in 1 BOTTLECAPSULE905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-396-30EA - Each63187-396af6c7c08-ed30-45c8-bb4d-1ef54aeed03412017-11-06
63187-396-60EA - Each63187-396f44411b0-9b92-4380-a758-813a083caac912017-03-06
63187-396-90EA - Each63187-396e9075e17-52d1-475b-a771-2af7cebfd55412019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-396NORTRIPTYLINE HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]5Current NDC, Legacy NDC, 3 package rows20220716_59a65e6f-b812-4195-b85b-c412fb902c93.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
317136nortriptyline HCl 25 MG Oral CapsulePSN59a65e6f-b812-4195-b85b-c412fb902c935
317136nortriptyline 25 MG Oral CapsuleSCD59a65e6f-b812-4195-b85b-c412fb902c935
317136nortriptyline (as nortriptyline HCl) 25 MG Oral CapsuleSY59a65e6f-b812-4195-b85b-c412fb902c935

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-396-306318703963030 CAPSULE in 1 BOTTLE (63187-396-30) 30 capsule2016-10-030000-00-00NoNoCurrent
63187-396-606318703966060 CAPSULE in 1 BOTTLE (63187-396-60) 60 capsule2016-10-030000-00-00NoNoCurrent
63187-396-906318703969090 CAPSULE in 1 BOTTLE (63187-396-90) 90 capsule2016-10-030000-00-00NoNoCurrent