Naproxen sodium
- Product NDC
- 85509-1495
- 11-digit product format
- 855091495
- Labeler code
- 85509
- Product ID
- 85509-1495_4b97c5af-891e-98f4-e063-6394a90ab4ea
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Naproxen sodium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- PHOENIX RX LLC
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Naproxen sodium
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| NAPROXEN SODIUM | 550 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 9TN87S3A3C |
| Rxcui | 849431 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 85509-1495-3 | Naproxen sodium | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 2 |
| 85509-1495-6 | Naproxen sodium | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 2 |
| 85509-1495-9 | Naproxen sodium | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 85509-1495-3 | 85509149503 | 30 TABLET, FILM COATED in 1 BOTTLE (85509-1495-3) | 2026-01-07 | No | No | Historical |
| 85509-1495-6 | 85509149506 | 60 TABLET, FILM COATED in 1 BOTTLE (85509-1495-6) | 2026-01-07 | No | No | Historical |
| 85509-1495-9 | 85509149509 | 90 TABLET, FILM COATED in 1 BOTTLE (85509-1495-9) | 2026-01-07 | No | No | Historical |