Doxepin Hydrochloride

Product NDC
72789-220
11-digit product format
727890220
Labeler code
72789
Product ID
72789-220_2ad0418c-56c4-50a0-e063-6394a90a35ca
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxepin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
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
72789-220-307278902203030 CAPSULE in 1 BOTTLE, PLASTIC (72789-220-30) 30 capsule2021-12-22NoNoHistorical
72789-220-907278902209090 CAPSULE in 1 BOTTLE, PLASTIC (72789-220-90) 90 capsule2024-09-06NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Doxepin Hydrochloride Capsules USP Rx onlyPD-Rx Pharmaceuticals, Inc.2025-01-03HUMAN PRESCRIPTION DRUG LABEL9