Naproxen
- Product NDC
- 68134-201
- 11-digit product format
- 681340201
- Labeler code
- 68134
- Product ID
- 68134-201_038a4d16-fbfb-4295-8da7-3bd71a73df3b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Naproxen
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- Palmetto Pharmaceuticals
- Application
- ANDA074190
- Marketing category
- ANDA
- Marketing start
- 2013-06-25
- Marketing end
- 2022-08-31
- Substance
- NAPROXEN
- Active strength
- 125 mg/5mL
- Pharmacologic classes
- Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68134-201-16 | 68134020116 | 500 mL in 1 BOTTLE, PLASTIC (68134-201-16) | 500 ml | 2015-11-24 | 2022-08-31 | No | No | Current |