Nortriptyline Hydrochloride

Product NDC
67046-1661
11-digit product format
670461661
Labeler code
67046
Product ID
67046-1661_4c21abdb-f3d8-9037-e063-6294a90af4b4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nortriptyline Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Coupler LLC
Application
ANDA074132
Marketing category
ANDA
Marketing start
2026-03-03
Substance
NORTRIPTYLINE HYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Tricyclic Antidepressant [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
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
67046-1661-36704616610330 CAPSULE in 1 BLISTER PACK (67046-1661-3) 30 capsule2026-03-03NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Nortriptyline Hydrochloride Capsules, USP Rx onlyCoupler LLC2026-03-03HUMAN PRESCRIPTION DRUG LABEL1