Nortriptyline Hydrochloride

Product NDC
68788-8900
11-digit product format
687888900
Labeler code
68788
Product ID
68788-8900_60763e7a-d22c-47d5-a260-f64bd4a4f654
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nortriptyline Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA073556
Marketing category
ANDA
Marketing start
2025-07-10
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
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
53e88688-54e1-9681-22b8-e499bd715088Product name220210729

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-8900-3Nortriptyline Hydrochloride30 in 1 BOTTLE, PLASTICCAPSULE301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8900-3EA - Each68788-89004268df0c-193e-4738-bc59-e45cbaa4490f12025-08-11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198045nortriptyline HCl 10 MG Oral CapsulePSN60763e7a-d22c-47d5-a260-f64bd4a4f6541
198045nortriptyline 10 MG Oral CapsuleSCD60763e7a-d22c-47d5-a260-f64bd4a4f6541
198045nortriptyline (as nortriptyline HCl) 10 MG Oral CapsuleSY60763e7a-d22c-47d5-a260-f64bd4a4f6541

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8900-36878889000330 CAPSULE in 1 BOTTLE, PLASTIC (68788-8900-3) 30 capsule2025-07-10NoNoCurrent