Doxepin hydrochloride

Product NDC
82804-011
11-digit product format
828040011
Labeler code
82804
Product ID
82804-011_7cfbb3d0-f19f-4977-ad0f-77676a8c6f83
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxepin hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
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
82804-011-308280400113030 CAPSULE in 1 BOTTLE (82804-011-30) 30 capsule2023-09-21NoNoHistorical
82804-011-608280400116060 CAPSULE in 1 BOTTLE (82804-011-60) 60 capsule2023-09-21NoNoHistorical
82804-011-908280400119090 CAPSULE in 1 BOTTLE (82804-011-90) 90 capsule2023-09-21NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Doxepin Hydrochloride Capsules, USPProficient Rx LP2023-09-01HUMAN PRESCRIPTION DRUG LABEL1