FDA.reportPublic FDA data

Nortriptyline Hydrochloride

Product NDC
70710-1154
11-digit product format
707101154
Labeler code
70710
Product ID
70710-1154_eb495cd8-4bb8-40f5-b578-5e5b9d49b772
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nortriptyline Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Zydus Pharmaceuticals (USA) Inc.
Application
ANDA213441
Marketing category
ANDA
Marketing start
2022-02-10
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
Rxcui198045, 198046, 198047, 317136

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
70710-1154-1Nortriptyline Hydrochloride100 in 1 BOTTLECAPSULE1002
70710-1154-3Nortriptyline Hydrochloride30 in 1 BOTTLECAPSULE302
70710-1154-5Nortriptyline Hydrochloride500 in 1 BOTTLECAPSULE5002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70710-1154NORTRIPTYLINE HYDROCHLORIDE CAPSULE [ZYDUS PHARMACEUTICALS (USA) INC.]2Current NDC, Legacy NDC, 3 package rows20240328_dbe85bdc-17a1-4201-bf48-a52e35d69b68.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198045nortriptyline HCl 10 MG Oral CapsulePSNdbe85bdc-17a1-4201-bf48-a52e35d69b682
317136nortriptyline HCl 25 MG Oral CapsulePSNdbe85bdc-17a1-4201-bf48-a52e35d69b682
198046nortriptyline HCl 50 MG Oral CapsulePSNdbe85bdc-17a1-4201-bf48-a52e35d69b682
198047nortriptyline HCl 75 MG Oral CapsulePSNdbe85bdc-17a1-4201-bf48-a52e35d69b682
198045nortriptyline 10 MG Oral CapsuleSCDdbe85bdc-17a1-4201-bf48-a52e35d69b682
317136nortriptyline 25 MG Oral CapsuleSCDdbe85bdc-17a1-4201-bf48-a52e35d69b682
198046nortriptyline 50 MG Oral CapsuleSCDdbe85bdc-17a1-4201-bf48-a52e35d69b682
198047nortriptyline 75 MG Oral CapsuleSCDdbe85bdc-17a1-4201-bf48-a52e35d69b682
198045nortriptyline (as nortriptyline HCl) 10 MG Oral CapsuleSYdbe85bdc-17a1-4201-bf48-a52e35d69b682
317136nortriptyline (as nortriptyline HCl) 25 MG Oral CapsuleSYdbe85bdc-17a1-4201-bf48-a52e35d69b682
198046nortriptyline (as nortriptyline HCl) 50 MG Oral CapsuleSYdbe85bdc-17a1-4201-bf48-a52e35d69b682
198047nortriptyline (as nortriptyline HCl) 75 MG Oral CapsuleSYdbe85bdc-17a1-4201-bf48-a52e35d69b682

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70710-1154-170710115401100 CAPSULE in 1 BOTTLE (70710-1154-1) 100 capsule2022-02-100000-00-00NoNoCurrent
70710-1154-37071011540330 CAPSULE in 1 BOTTLE (70710-1154-3) 30 capsule2022-02-100000-00-00NoNoCurrent
70710-1154-570710115405500 CAPSULE in 1 BOTTLE (70710-1154-5) 500 capsule2022-02-100000-00-00NoNoCurrent