Naproxen Sodium

Product NDC
63187-121
11-digit product format
631870121
Labeler code
63187
Product ID
63187-121_dc4f3c12-86c1-4697-bfe0-b63b7cdd159c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen Sodium
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA078432
Marketing category
ANDA
Marketing start
2007-04-26
Marketing end
0000-00-00
Substance
NAPROXEN SODIUM
Active strength
550 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63187-121-602019-12-06C16284748780-19855e2a2-4ac1-60a7-e053-dbdaa90a05bdda9b993d-3eb5-4b11-a292-62e378d70fb2
63187-121-602019-11-27C16284748780-19855e2a2-4ac1-60a7-e053-dbdaa90a05bdda9b993d-3eb5-4b11-a292-62e378d70fb2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-121NAPROXEN SODIUM TABLET [PROFICIENT RX LP]2Legacy NDC20191207_da9b993d-3eb5-4b11-a292-62e378d70fb2.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-121-606318701216060 TABLET in 1 BOTTLE (63187-121-60) 60 tablet2014-08-010000-00-00NoNoCurrent