Oxazepam

Product NDC
43353-965
11-digit product format
433530965
Labeler code
43353
Product ID
43353-965_d630cdd9-fe25-4ea6-8a1f-0100bb6e6cb5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxazepam
Dosage form
CAPSULE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA071813
Marketing category
ANDA
Marketing start
1988-04-19
Marketing end
0000-00-00
Substance
OXAZEPAM
Active strength
10 mg/1
Pharmacologic classes
Benzodiazepine [EPC],Benzodiazepines [CS]
DEA schedule
CIV
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
43353-965-30EA - Each43353-96530372b76-055e-4c15-bf01-4f2610c1fee312016-07-19
43353-965-53EA - Each43353-965863e0183-fcfb-43f7-b59a-806488ef509112016-07-19
43353-965-60EA - Each43353-96583352b66-cd78-4ace-b1cd-53eec622f5a512016-07-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-965OXAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Legacy NDC20160712_1382470a-7eec-4e7c-aa86-15254fb57a5a.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43353-965-304335309653030 CAPSULE in 1 BOTTLE (43353-965-30) 30 capsule2014-10-250000-00-00NoNoCurrent
43353-965-534335309655360 CAPSULE in 1 BOTTLE (43353-965-53) 60 capsule2014-09-300000-00-00NoNoCurrent
43353-965-604335309656090 CAPSULE in 1 BOTTLE (43353-965-60) 90 capsule2014-10-250000-00-00NoNoCurrent