NAPROXEN SODIUM

Product NDC
42291-517
11-digit product format
422910517
Labeler code
42291
Product ID
42291-517_d57d2ee2-b4c6-82e9-e053-2995a90a7499
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
NAPROXEN SODIUM
Dosage form
TABLET
Route
ORAL
Labeler
AvKARE
Application
ANDA078432
Marketing category
ANDA
Marketing start
2017-10-30
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
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42291-517-01EA - Each42291-517c5aa2a07-70d9-43d4-a668-7ba645cab3a512018-01-12
42291-517-50EA - Each42291-517814ce398-62aa-4245-bf8a-f5427527656912017-12-14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42291-517-0142291051701100 TABLET in 1 BOTTLE (42291-517-01) 100 tablet2017-10-300000-00-00NoNoCurrent
42291-517-5042291051750500 TABLET in 1 BOTTLE (42291-517-50) 500 tablet2017-10-300000-00-00NoNoCurrent