Doxepin Hydrochloride

Product NDC
0378-5390
11-digit product format
003785390
Labeler code
0378
Product ID
0378-5390_7762beed-7ba4-4602-ba23-dc0aa553eb3c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
doxepin hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA202337
Marketing category
ANDA
Marketing start
2021-01-05
Marketing end
2023-05-31
Substance
DOXEPIN HYDROCHLORIDE
Active strength
3 mg/1
Pharmacologic classes
Tricyclic Antidepressant [EPC]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-5390-93EA - Each0378-53900c8b544d-7036-4f26-a4d5-84be295fae1112021-02-05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0378-5390-930037853909330 TABLET in 1 BOTTLE, PLASTIC (0378-5390-93) 30 tablet2021-01-050000-00-00NoNoCurrent