Naproxen
- Product NDC
- 51655-657
- 11-digit product format
- 516550657
- Labeler code
- 51655
- Product ID
- 51655-657_4b821655-3d91-3670-e063-6394a90a72b3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Naproxen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Northwind Health Company, LLC
- Application
- ANDA212517
- Marketing category
- ANDA
- Marketing start
- 2021-04-01
- Substance
- NAPROXEN
- Active strength
- 375 mg/1
- Pharmacologic classes
- Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 57Y76R9ATQ | NAPROXEN | 22204-53-1 | NAPROXEN |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 51655-657-52 | 51655065752 | 30 TABLET in 1 BOTTLE, PLASTIC (51655-657-52) | 30 tablet | 2021-04-01 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Naproxen | Northwind Health Company, LLC | 2026-01-01 | HUMAN PRESCRIPTION DRUG LABEL | 5 |