FDA.reportPublic FDA data

Nortriptyline Hydrochloride

Product NDC
71335-2772
11-digit product format
713352772
Labeler code
71335
Product ID
71335-2772_08c0027e-4168-43c2-a7d9-f6555bf250ef
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nortriptyline Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA073556
Marketing category
ANDA
Marketing start
2023-11-17
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
71335-2772-1Nortriptyline Hydrochloride30 in 1 BOTTLE, PLASTICCAPSULE301
71335-2772-2Nortriptyline Hydrochloride60 in 1 BOTTLE, PLASTICCAPSULE601
71335-2772-3Nortriptyline Hydrochloride90 in 1 BOTTLE, PLASTICCAPSULE901
71335-2772-4Nortriptyline Hydrochloride100 in 1 BOTTLE, PLASTICCAPSULE1001
71335-2772-5Nortriptyline Hydrochloride120 in 1 BOTTLE, PLASTICCAPSULE1201
71335-2772-6Nortriptyline Hydrochloride15 in 1 BOTTLE, PLASTICCAPSULE151

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198045nortriptyline HCl 10 MG Oral CapsulePSN6b055ebf-ed9e-44c5-bc03-6b6480d143771
198045nortriptyline 10 MG Oral CapsuleSCD6b055ebf-ed9e-44c5-bc03-6b6480d143771
198045nortriptyline (as nortriptyline HCl) 10 MG Oral CapsuleSY6b055ebf-ed9e-44c5-bc03-6b6480d143771

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2772-17133527720130 CAPSULE in 1 BOTTLE, PLASTIC (71335-2772-1) 30 capsule2025-10-13NoNoCurrent
71335-2772-27133527720260 CAPSULE in 1 BOTTLE, PLASTIC (71335-2772-2) 60 capsule2025-10-13NoNoCurrent
71335-2772-37133527720390 CAPSULE in 1 BOTTLE, PLASTIC (71335-2772-3) 90 capsule2025-10-13NoNoCurrent
71335-2772-471335277204100 CAPSULE in 1 BOTTLE, PLASTIC (71335-2772-4) 100 capsule2025-10-13NoNoCurrent
71335-2772-571335277205120 CAPSULE in 1 BOTTLE, PLASTIC (71335-2772-5) 120 capsule2025-10-13NoNoCurrent
71335-2772-67133527720615 CAPSULE in 1 BOTTLE, PLASTIC (71335-2772-6) 15 capsule2025-10-13NoNoCurrent