Doxepin Hydrochloride

Product NDC
71335-2804
11-digit product format
713352804
Labeler code
71335
Product ID
71335-2804_a1efdaac-6a7a-4f99-ba57-6dee8278bc54
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxepin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA215113
Marketing category
ANDA
Marketing start
2022-06-27
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
71335-2804-17133528040160 CAPSULE in 1 BOTTLE, PLASTIC (71335-2804-1) 60 capsule2025-10-13NoNoHistorical
71335-2804-27133528040230 CAPSULE in 1 BOTTLE, PLASTIC (71335-2804-2) 30 capsule2025-10-13NoNoHistorical
71335-2804-37133528040390 CAPSULE in 1 BOTTLE, PLASTIC (71335-2804-3) 90 capsule2025-10-13NoNoHistorical
71335-2804-471335280404120 CAPSULE in 1 BOTTLE, PLASTIC (71335-2804-4) 120 capsule2025-10-13NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Doxepin Hydrochloride Capsules, USPBryant Ranch Prepack2025-10-13HUMAN PRESCRIPTION DRUG LABEL1