Nortriptyline Hydrochloride

Product NDC
68788-8568
11-digit product format
687888568
Labeler code
68788
Product ID
68788-8568_11725d25-b6d9-4270-856d-418e4353be9f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nortriptyline Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA074132
Marketing category
ANDA
Marketing start
2024-01-18
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
68788-8568-3Nortriptyline Hydrochloride30 in 1 BOTTLECAPSULE302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8568-3EA - Each68788-85686099834e-ea43-4667-a8b4-49207ea58d4612024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8568NORTRIPTYLINE HYDROCHLORIDE CAPSULE [PREFERRED PHARMACEUTICALS INC.]1Current NDC, 1 package rows20240207_af950b46-07df-4de6-a221-d3d7059b87a1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
317136nortriptyline HCl 25 MG Oral CapsulePSNaf950b46-07df-4de6-a221-d3d7059b87a12
317136nortriptyline 25 MG Oral CapsuleSCDaf950b46-07df-4de6-a221-d3d7059b87a12
317136nortriptyline (as nortriptyline HCl) 25 MG Oral CapsuleSYaf950b46-07df-4de6-a221-d3d7059b87a12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8568-36878885680330 CAPSULE in 1 BOTTLE (68788-8568-3) 30 capsule2024-01-18NoNoHistorical