naproxen

Product NDC
70518-1511
11-digit product format
705181511
Labeler code
70518
Product ID
70518-1511_93fab968-a424-7c36-e053-2a95a90af438
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
naproxen
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA091305
Marketing category
ANDA
Marketing start
2018-10-09
Marketing end
0000-00-00
Substance
NAPROXEN
Active strength
375 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