Oxazepam

Product NDC
43353-980
11-digit product format
433530980
Labeler code
43353
Product ID
43353-980_d630cdd9-fe25-4ea6-8a1f-0100bb6e6cb5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxazepam
Dosage form
CAPSULE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA071814
Marketing category
ANDA
Marketing start
1988-04-19
Marketing end
0000-00-00
Substance
OXAZEPAM
Active strength
30 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
43353-980-30EA - Each43353-98008ae973a-0555-424e-b841-899e6f663aaa12016-07-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-980OXAZEPAM 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
43353-980-304335309803030 CAPSULE in 1 BOTTLE (43353-980-30) 30 capsule2014-11-060000-00-00NoNoCurrent