Naproxen sodium
- Product NDC
- 71335-1650
- 11-digit product format
- 713351650
- Labeler code
- 71335
- Product ID
- 71335-1650_2bd1f190-c76c-4003-9ab9-1c6c27dde97a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Naproxen sodium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA078486
- Marketing category
- ANDA
- Marketing start
- 2016-04-26
- Substance
- NAPROXEN SODIUM
- Active strength
- 550 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
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 9TN87S3A3C | NAPROXEN SODIUM | 26159-34-2 | NAPROXEN SODIUM |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 71335-1650-0 | 71335165000 | 6 TABLET, FILM COATED in 1 BOTTLE (71335-1650-0) | 2024-08-12 | No | No | Historical |
| 71335-1650-1 | 71335165001 | 20 TABLET, FILM COATED in 1 BOTTLE (71335-1650-1) | 2024-08-12 | No | No | Historical |
| 71335-1650-2 | 71335165002 | 100 TABLET, FILM COATED in 1 BOTTLE (71335-1650-2) | 2024-08-12 | No | No | Historical |
| 71335-1650-3 | 71335165003 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-1650-3) | 2020-06-23 | No | No | Historical |
| 71335-1650-4 | 71335165004 | 120 TABLET, FILM COATED in 1 BOTTLE (71335-1650-4) | 2024-08-12 | No | No | Historical |
| 71335-1650-5 | 71335165005 | 60 TABLET, FILM COATED in 1 BOTTLE (71335-1650-5) | 2024-08-12 | No | No | Historical |
| 71335-1650-6 | 71335165006 | 90 TABLET, FILM COATED in 1 BOTTLE (71335-1650-6) | 2024-08-12 | No | No | Historical |
| 71335-1650-7 | 71335165007 | 42 TABLET, FILM COATED in 1 BOTTLE (71335-1650-7) | 2024-08-12 | No | No | Historical |
| 71335-1650-8 | 71335165008 | 14 TABLET, FILM COATED in 1 BOTTLE (71335-1650-8) | 2024-08-12 | No | No | Historical |
| 71335-1650-9 | 71335165009 | 56 TABLET, FILM COATED in 1 BOTTLE (71335-1650-9) | 2024-08-12 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Naproxen sodium | Bryant Ranch Prepack | 2024-08-12 | HUMAN PRESCRIPTION DRUG LABEL | 3 |