Doxepin Hydrochloride

Product NDC
71205-534
11-digit product format
712050534
Labeler code
71205
Product ID
71205-534_e98f371e-f7fe-4c8f-9491-6eb4c53d43ad
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxepin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA211603
Marketing category
ANDA
Marketing start
2019-03-27
Substance
DOXEPIN HYDROCHLORIDE
Active strength
10 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
71205-534-307120505343030 CAPSULE in 1 BOTTLE (71205-534-30) 30 capsule2021-02-16NoNoHistorical
71205-534-607120505346060 CAPSULE in 1 BOTTLE (71205-534-60) 60 capsule2021-02-16NoNoHistorical
71205-534-907120505349090 CAPSULE in 1 BOTTLE (71205-534-90) 90 capsule2021-02-16NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Doxepin Hydrochloride Capsules USP Rx onlyProficient Rx LP2021-02-01HUMAN PRESCRIPTION DRUG LABEL1