Naproxen
- Product NDC
- 70518-1064
- 11-digit product format
- 705181064
- Labeler code
- 70518
- Product ID
- 70518-1064_900fe903-045e-19d9-e053-2995a90a8531
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Naproxen
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA075227
- Marketing category
- ANDA
- Marketing start
- 2018-03-14
- 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