NAPROXEN SODIUM

Product NDC
42291-516
11-digit product format
422910516
Labeler code
42291
Product ID
42291-516_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
275 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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42291-516-0142291051601100 TABLET in 1 BOTTLE (42291-516-01) 100 tablet2017-10-300000-00-00NoNoCurrent