Doxepin hydrochloride

Product NDC
71335-2188
11-digit product format
713352188
Labeler code
71335
Product ID
71335-2188_e065f520-615b-4d20-9652-1c4a96ff001b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxepin hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA212624
Marketing category
ANDA
Marketing start
2019-12-20
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
71335-2188-17133521880130 CAPSULE in 1 BOTTLE (71335-2188-1) 30 capsule2022-11-15NoNoHistorical
71335-2188-27133521880260 CAPSULE in 1 BOTTLE (71335-2188-2) 60 capsule2022-11-15NoNoHistorical
71335-2188-37133521880328 CAPSULE in 1 BOTTLE (71335-2188-3) 28 capsule2022-11-15NoNoHistorical
71335-2188-47133521880418 CAPSULE in 1 BOTTLE (71335-2188-4) 18 capsule2022-11-15NoNoHistorical
71335-2188-57133521880590 CAPSULE in 1 BOTTLE (71335-2188-5) 90 capsule2022-11-15NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Doxepin Hydrochloride Capsules, USPBryant Ranch Prepack2023-11-16HUMAN PRESCRIPTION DRUG LABEL101