FDA.reportPublic FDA data

Nortriptyline Hydrochloride

Product NDC
71335-2350
11-digit product format
713352350
Labeler code
71335
Product ID
71335-2350_de439594-70b2-4d22-b955-2063a4c512d8
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
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
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
53e88688-54e1-9681-22b8-e499bd715088Product name220210729

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-2350-2Nortriptyline Hydrochloride60 in 1 BOTTLE, PLASTICCAPSULE60100
71335-2350-4Nortriptyline Hydrochloride30 in 1 BOTTLE, PLASTICCAPSULE30100
71335-2350-5Nortriptyline Hydrochloride90 in 1 BOTTLE, PLASTICCAPSULE90100
71335-2350-6Nortriptyline Hydrochloride50 in 1 BOTTLE, PLASTICCAPSULE50100
71335-2350-7Nortriptyline Hydrochloride100 in 1 BOTTLE, PLASTICCAPSULE100100
71335-2350-8Nortriptyline Hydrochloride120 in 1 BOTTLE, PLASTICCAPSULE120100
71335-2350-9Nortriptyline Hydrochloride28 in 1 BOTTLE, PLASTICCAPSULE28100

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2350-4EA - Each71335-2350882ad0c1-f683-420e-aa3d-0a44f77c97a012025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2350NORTRIPTYLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]100Current NDC, 7 package rows20240223_8811104b-6223-4ea6-a9c6-61d63a21b3cd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
317136nortriptyline HCl 25 MG Oral CapsulePSN8811104b-6223-4ea6-a9c6-61d63a21b3cd100
317136nortriptyline 25 MG Oral CapsuleSCD8811104b-6223-4ea6-a9c6-61d63a21b3cd100
317136nortriptyline (as nortriptyline HCl) 25 MG Oral CapsuleSY8811104b-6223-4ea6-a9c6-61d63a21b3cd100

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2350-27133523500260 CAPSULE in 1 BOTTLE, PLASTIC (71335-2350-2) 60 capsule2024-02-21NoNoCurrent
71335-2350-47133523500430 CAPSULE in 1 BOTTLE, PLASTIC (71335-2350-4) 30 capsule2024-02-21NoNoCurrent
71335-2350-57133523500590 CAPSULE in 1 BOTTLE, PLASTIC (71335-2350-5) 90 capsule2024-02-21NoNoCurrent
71335-2350-67133523500650 CAPSULE in 1 BOTTLE, PLASTIC (71335-2350-6) 50 capsule2024-02-21NoNoCurrent
71335-2350-771335235007100 CAPSULE in 1 BOTTLE, PLASTIC (71335-2350-7) 100 capsule2024-02-21NoNoCurrent
71335-2350-871335235008120 CAPSULE in 1 BOTTLE, PLASTIC (71335-2350-8) 120 capsule2024-02-21NoNoCurrent
71335-2350-97133523500928 CAPSULE in 1 BOTTLE, PLASTIC (71335-2350-9) 28 capsule2024-02-21NoNoCurrent