Doxepin Hydrochloride

Product NDC
71335-1941
11-digit product format
713351941
Labeler code
71335
Product ID
71335-1941_e5eab47e-ac23-4fed-8ed1-ae046daa85e9
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
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
71335-1941-17133519410130 CAPSULE in 1 BOTTLE (71335-1941-1) 30 capsule2021-12-29NoNoHistorical
71335-1941-27133519410260 CAPSULE in 1 BOTTLE (71335-1941-2) 60 capsule2021-12-29NoNoHistorical
71335-1941-37133519410328 CAPSULE in 1 BOTTLE (71335-1941-3) 28 capsule2021-12-29NoNoHistorical
71335-1941-47133519410418 CAPSULE in 1 BOTTLE (71335-1941-4) 18 capsule2021-12-29NoNoHistorical
71335-1941-57133519410590 CAPSULE in 1 BOTTLE (71335-1941-5) 90 capsule2021-08-31NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Doxepin Hydrochloride Capsules, USP 10 mg, 25 mg, 50 mg, 75 mg and 100 mgBryant Ranch Prepack2024-05-23HUMAN PRESCRIPTION DRUG LABEL103