Naproxen Sodium
- Product NDC
- 68210-4120
- 11-digit product format
- 682104120
- Labeler code
- 68210
- Product ID
- 68210-4120_b84164e0-ac3c-131e-e053-2995a90a8184
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Naproxen Sodium
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Spirit Pharmaceuticals LLC
- Application
- ANDA207612
- Marketing category
- ANDA
- Marketing start
- 2020-03-23
- Marketing end
- 0000-00-00
- Substance
- NAPROXEN SODIUM
- Active strength
- 220 1/1
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68210-4120-1 | Naproxen Sodium | 1 in 1 CARTON | TABLET, FILM COATED, EXTENDED RE | 1 | | 1 |
| 68210-4120-1 | Naproxen Sodium | 15 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 15 | | 1 |
| 68210-4120-2 | Naproxen Sodium | 10 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 10 | | 1 |
| 68210-4120-2 | Naproxen Sodium | 1 in 1 CARTON | TABLET, FILM COATED, EXTENDED RE | 1 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68210-4120 | NAPROXEN SODIUM TABLET, FILM COATED, EXTENDED RELEASE [SPIRIT PHARMACEUTICALS LLC] | 1 | Legacy NDC, 4 package rows | 20210107_36e6f894-d181-4613-bf10-93bb156a12ec.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68210-4120-1 | 68210412001 | 1 BOTTLE in 1 CARTON (68210-4120-1) > 15 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE | 1 bottle | 2020-03-23 | 0000-00-00 | No | No | Current |
| 68210-4120-2 | 68210412002 | 1 BOTTLE in 1 CARTON (68210-4120-2) > 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE | 1 bottle | 2020-03-23 | 0000-00-00 | No | No | Current |