Naproxen Sodium
- Product NDC
- 42291-531
- 11-digit product format
- 422910531
- Labeler code
- 42291
- Product ID
- 42291-531_9c5dc336-0fca-f335-e053-2995a90ad50b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Naproxen Sodium
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- AvKARE, Inc.
- Application
- ANDA078432
- Marketing category
- ANDA
- Marketing start
- 2009-10-21
- 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
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 42291-531-01 | 42291053101 | 100 TABLET in 1 BOTTLE (42291-531-01) | 100 tablet | 2009-10-21 | 0000-00-00 | No | No | Current |