Naproxen Sodium
- Product NDC
- 58602-819
- 11-digit product format
- 586020819
- Labeler code
- 58602
- Product ID
- 58602-819_915208d0-ee3a-4b1f-9c3c-76d9cb8362c9
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Naproxen Sodium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aurohealth LLC
- Application
- ANDA205497
- Marketing category
- ANDA
- Marketing start
- 2017-12-11
- 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 |
|---|
| 58602-819-07 | Naproxen Sodium | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 9 |
| 58602-819-07 | Naproxen Sodium | 24 in 1 BOTTLE | TABLET, FILM COATED | 24 | | 9 |
| 58602-819-14 | Naproxen Sodium | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 9 |
| 58602-819-14 | Naproxen Sodium | 50 in 1 BOTTLE | TABLET, FILM COATED | 50 | | 9 |
| 58602-819-19 | Naproxen Sodium | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 9 |
| 58602-819-19 | Naproxen Sodium | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 9 |
| 58602-819-21 | Naproxen Sodium | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 9 |
| 58602-819-21 | Naproxen Sodium | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 9 |
| 58602-819-29 | Naproxen Sodium | 150 in 1 BOTTLE | TABLET, FILM COATED | 150 | | 9 |
| 58602-819-29 | Naproxen Sodium | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 9 |
| 58602-819-38 | Naproxen Sodium | 300 in 1 BOTTLE | TABLET, FILM COATED | 300 | | 9 |
| 58602-819-38 | Naproxen Sodium | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 9 |
| 58602-819-40 | Naproxen Sodium | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 9 |
| 58602-819-40 | Naproxen Sodium | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 58602-819 | NAPROXEN SODIUM TABLET, FILM COATED [AUROHEALTH LLC] | 9 | Current NDC, Legacy NDC, 14 package rows | 20250524_46a15412-25d6-454d-86db-70321d19a2c9.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 58602-819-07 | 58602081907 | 1 BOTTLE in 1 CARTON (58602-819-07) / 24 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2021-10-25 | 0000-00-00 | No | No | Current |
| 58602-819-14 | 58602081914 | 1 BOTTLE in 1 CARTON (58602-819-14) / 50 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2017-12-11 | 0000-00-00 | No | No | Current |
| 58602-819-19 | 58602081919 | 1 BOTTLE in 1 CARTON (58602-819-19) / 90 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2023-09-21 | | No | No | Current |
| 58602-819-21 | 58602081921 | 1 BOTTLE in 1 CARTON (58602-819-21) / 100 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2017-12-11 | 0000-00-00 | No | No | Current |
| 58602-819-29 | 58602081929 | 1 BOTTLE in 1 CARTON (58602-819-29) / 150 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2021-10-25 | 0000-00-00 | No | No | Current |
| 58602-819-38 | 58602081938 | 1 BOTTLE in 1 CARTON (58602-819-38) / 300 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2021-10-25 | 0000-00-00 | No | No | Current |
| 58602-819-40 | 58602081940 | 1 BOTTLE in 1 CARTON (58602-819-40) / 500 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2021-10-25 | 0000-00-00 | No | No | Current |