Naproxen

Product NDC
43353-201
11-digit product format
433530201
Labeler code
43353
Product ID
43353-201_9d397bfd-f53e-42ca-8e0f-5392b6324e15
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA091305
Marketing category
ANDA
Marketing start
2012-01-23
Marketing end
0000-00-00
Substance
NAPROXEN
Active strength
250 mg/1
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-201NAPROXEN TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Legacy NDC20160714_84ee4538-e051-4a6e-b961-c1a40ca09d1b.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43353-201-7043353020170120 TABLET in 1 BOTTLE (43353-201-70) 120 tablet2016-06-290000-00-00NoNoCurrent