Doxepin Hydrochloride

Product NDC
71335-2817
11-digit product format
713352817
Labeler code
71335
Product ID
71335-2817_76790e6b-5c03-4e4d-9b29-d54f29d8e9fd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
doxepin hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA215710
Marketing category
ANDA
Marketing start
2022-02-10
Substance
DOXEPIN 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
3U9A0FE9N5DOXEPIN HYDROCHLORIDE1229-29-4DOXEPIN HYDROCHLORIDE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2817-17133528170130 CAPSULE in 1 BOTTLE (71335-2817-1) 30 capsule2025-10-16NoNoHistorical
71335-2817-27133528170260 CAPSULE in 1 BOTTLE (71335-2817-2) 60 capsule2025-10-16NoNoHistorical
71335-2817-37133528170328 CAPSULE in 1 BOTTLE (71335-2817-3) 28 capsule2025-10-16NoNoHistorical
71335-2817-47133528170418 CAPSULE in 1 BOTTLE (71335-2817-4) 18 capsule2025-10-16NoNoHistorical
71335-2817-57133528170590 CAPSULE in 1 BOTTLE (71335-2817-5) 90 capsule2025-10-16NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Doxepin HydrochlorideBryant Ranch Prepack2025-10-16HUMAN PRESCRIPTION DRUG LABEL1