Doxepin Hydrochloride

Product NDC
69238-1733
11-digit product format
692381733
Labeler code
69238
Product ID
69238-1733_f44f392e-0f43-4e5d-a2c4-0b15387d67ac
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxepin Hydrochloride
Dosage form
CREAM
Route
TOPICAL
Labeler
Amneal Pharmaceuticals NY LLC
Application
ANDA212357
Marketing category
ANDA
Marketing start
2023-08-21
Substance
DOXEPIN HYDROCHLORIDE
Active strength
50 mg/g
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
69238-1733-6692381733061 TUBE in 1 CARTON (69238-1733-6) / 45 g in 1 TUBE1 tube2023-08-21NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Doxepin Hydrochloride Cream, 5%Amneal Pharmaceuticals NY LLC | Amneal Pharmaceuticals, LLC2023-08-17HUMAN PRESCRIPTION DRUG LABEL8