Naproxen Sodium
- Product NDC
- 51316-608
- 11-digit product format
- 513160608
- Labeler code
- 51316
- Product ID
- 51316-608_3c14f8af-cefb-ec0f-e063-6394a90a2caa
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Naproxen sodium 220mg
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- CVS Pharmacy, Inc.
- Application
- ANDA090545
- Marketing category
- ANDA
- Marketing start
- 2025-05-01
- Substance
- NAPROXEN SODIUM
- Active strength
- 220 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Naproxen Sodium
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| NAPROXEN SODIUM | 220 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 9TN87S3A3C |
| Rxcui | 849574 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 51316-608-90 | Naproxen Sodium | 90 in 1 BOTTLE | TABLET | 90 | | 3 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 51316-608-90 | 51316060890 | 90 TABLET in 1 BOTTLE (51316-608-90) | 90 tablet | 2025-05-01 | No | No | Historical |