Doxepin Hydrochloride

Product NDC
71335-2408
11-digit product format
713352408
Labeler code
71335
Product ID
71335-2408_8e5a9620-a6e9-402a-aa93-da77ff5c8d98
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxepin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA213474
Marketing category
ANDA
Marketing start
2021-05-01
Substance
DOXEPIN HYDROCHLORIDE
Active strength
50 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
3U9A0FE9N5DOXEPIN HYDROCHLORIDE1229-29-4DOXEPIN HYDROCHLORIDE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2408-17133524080160 CAPSULE in 1 BOTTLE (71335-2408-1) 60 capsule2024-09-18NoNoHistorical
71335-2408-27133524080230 CAPSULE in 1 BOTTLE (71335-2408-2) 30 capsule2024-09-18NoNoHistorical
71335-2408-37133524080390 CAPSULE in 1 BOTTLE (71335-2408-3) 90 capsule2024-09-18NoNoHistorical
71335-2408-471335240804120 CAPSULE in 1 BOTTLE (71335-2408-4) 120 capsule2024-09-18NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Doxepin Hydrochloride Capsules, USP 10 mg, 25 mg, 50 mg, 75 mg and 100 mgBryant Ranch Prepack2024-09-18HUMAN PRESCRIPTION DRUG LABEL1