Naproxen Sodium

Product NDC
50268-592
11-digit product format
502680592
Labeler code
50268
Product ID
50268-592_b74afaaf-1442-41fe-8fab-f5dce214fff6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen Sodium
Dosage form
TABLET
Route
ORAL
Labeler
AvPAK
Application
ANDA078432
Marketing category
ANDA
Marketing start
2007-04-26
Marketing end
0000-00-00
Substance
NAPROXEN SODIUM
Active strength
275 mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50268-592-152022-02-03C16284748780-1d6a99b39-d3ca-a426-e053-dadaa90af4c29316bbe0-a194-d2a8-8f86-6d39e4d8f20e
50268-592-152022-01-28C16284748780-1d6a99b39-d3ca-a426-e053-dadaa90af4c29316bbe0-a194-d2a8-8f86-6d39e4d8f20e

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-592NAPROXEN SODIUM TABLET [AVPAK]8Legacy NDC20240105_9316bbe0-a194-d2a8-8f86-6d39e4d8f20e.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-592-155026805921550 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-592-15) > 1 TABLET in 1 BLISTER PACK (50268-592-11) 50 blister pack2012-10-160000-00-00NoNoCurrent