Trazodone Hydrochloride

Product NDC
43353-973
11-digit product format
433530973
Labeler code
43353
Product ID
43353-973_80bec5c1-751e-453c-b882-3dd39f349ef5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trazodone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA071523
Marketing category
ANDA
Marketing start
2014-02-06
Marketing end
0000-00-00
Substance
TRAZODONE HYDROCHLORIDE
Active strength
50 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-973-15EA - Each43353-9736fb1ad32-dfa0-492f-8471-3608c8628fca12016-07-19
43353-973-30EA - Each43353-9735d1a0a1f-ff0f-4025-a663-25883384880912016-07-19
43353-973-45EA - Each43353-9738049b7cb-9830-4604-834a-470c06a01ac012016-07-19
43353-973-53EA - Each43353-973b2ad8fc7-39b3-4357-8edd-49fec38a3e9312016-07-19
43353-973-70EA - Each43353-973b7c1497e-2a05-4932-8397-9aa8f7f1710212016-07-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-973TRAZODONE HYDROCHLORIDE (TRAZODONE HYDROCHLORIDE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Legacy NDC20160708_48ff193c-27e1-4e1f-bd38-4ea30b6323d1.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43353-973-154335309731515 TABLET in 1 BOTTLE (43353-973-15) 15 tablet2014-12-030000-00-00NoNoCurrent
43353-973-304335309733030 TABLET in 1 BOTTLE (43353-973-30) 30 tablet2014-10-280000-00-00NoNoCurrent
43353-973-454335309734545 TABLET in 1 BOTTLE (43353-973-45) 45 tablet2014-11-210000-00-00NoNoCurrent
43353-973-534335309735360 TABLET in 1 BOTTLE (43353-973-53) 60 tablet2014-10-140000-00-00NoNoCurrent
43353-973-7043353097370120 TABLET in 1 BOTTLE (43353-973-70) 120 tablet2014-11-210000-00-00NoNoCurrent