Naproxen Sodium
- Product NDC
- 69420-1375
- 11-digit product format
- 694201375
- Labeler code
- 69420
- Product ID
- 69420-1375_f34d9d85-4a82-43b6-bf5b-3b2893c6b009
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Naproxen Sodium
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- SA3, LLC
- Application
- NDA020353
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2019-05-01
- Substance
- NAPROXEN SODIUM
- 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
- 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 | 375 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 9TN87S3A3C |
| Rxcui | 1116320 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 69420-1375-1 | Naproxen Sodium | 100 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 100 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69420-1375 | NAPROXEN SODIUM TABLET, FILM COATED, EXTENDED RELEASE [SA3, LLC] | 1 | Current NDC, Legacy NDC, 1 package rows | 20190521_313dd447-4b9f-4e5b-8ca9-4a2a5a1a53d9.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 69420-1375-1 | 69420137501 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (69420-1375-1) | 2019-05-01 | 0000-00-00 | No | No | Current |