Nortriptyline Hydrochloride

Product NDC
80425-0534
11-digit product format
804250534
Labeler code
80425
Product ID
80425-0534_36b01073-3257-2901-e063-6394a90acbfe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nortriptyline Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Advanced Rx of Tennessee, LLC
Application
ANDA073556
Marketing category
ANDA
Marketing start
2025-06-03
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

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
00FN6IH15DNORTRIPTYLINE HYDROCHLORIDE894-71-3NORTRIPTYLINE HYDROCHLORIDE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80425-0534-18042505340130 CAPSULE in 1 BOTTLE, PLASTIC (80425-0534-1) 30 capsule2025-06-03NoNoHistorical
80425-0534-28042505340260 CAPSULE in 1 BOTTLE, PLASTIC (80425-0534-2) 60 capsule2025-06-03NoNoHistorical
80425-0534-38042505340390 CAPSULE in 1 BOTTLE, PLASTIC (80425-0534-3) 90 capsule2025-06-03NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Nortriptyline Hydrochloride Capsules, USPAdvanced Rx of Tennessee, LLC2025-06-03HUMAN PRESCRIPTION DRUG LABEL1