Trazodone Hydrochloride

Product NDC
43353-974
11-digit product format
433530974
Labeler code
43353
Product ID
43353-974_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
ANDA071524
Marketing category
ANDA
Marketing start
2014-02-06
Marketing end
0000-00-00
Substance
TRAZODONE HYDROCHLORIDE
Active strength
100 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
43353-974-30EA - Each43353-974792301d3-58a7-4cf7-902a-151a5179417412016-07-19
43353-974-53EA - Each43353-97423380805-820d-4ee4-902b-0186ae3fddb612016-07-19
43353-974-80EA - Each43353-974a52ca714-4d2a-4178-be14-805c8444ca1112016-07-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-974TRAZODONE 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
43353-974-304335309743030 TABLET in 1 BOTTLE (43353-974-30) 30 tablet2014-10-140000-00-00NoNoCurrent
43353-974-534335309745360 TABLET in 1 BOTTLE (43353-974-53) 60 tablet2014-12-040000-00-00NoNoCurrent
43353-974-8043353097480180 TABLET in 1 BOTTLE (43353-974-80) 180 tablet2014-12-040000-00-00NoNoCurrent