Sertraline Hydrochloride

Product NDC
43353-787
11-digit product format
433530787
Labeler code
43353
Product ID
43353-787_01211049-3b2e-4d9c-a26b-ff2b30bcb118
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sertraline
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, Inc.
Application
ANDA078626
Marketing category
ANDA
Marketing start
2012-02-03
Marketing end
0000-00-00
Substance
SERTRALINE HYDROCHLORIDE
Active strength
100 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-787-15EA - Each43353-78703dedb45-0ea5-4de0-9971-0f5627b00aef12013-04-01
43353-787-30EA - Each43353-787a1b09dea-4e44-4e99-9812-b2bc48565a7f12013-04-01
43353-787-45EA - Each43353-787dfaab8ee-053d-4b12-8237-77acac0af41312013-04-01
43353-787-53EA - Each43353-787666a5d0d-fc1d-42d1-95d1-be43ae2a515212013-04-01
43353-787-60EA - Each43353-7871c743356-6c97-41f4-983a-8cbe20ab50d812013-04-01
43353-787-73EA - Each43353-787f04bf1ff-b945-429d-93fe-756e25f5dfa512013-04-01
43353-787-80EA - Each43353-787121339a5-9d59-4f7c-b359-56cb3125f4b112013-04-01