Naproxen Sodium
- Product NDC
- 68210-4137
- 11-digit product format
- 682104137
- Labeler code
- 68210
- Product ID
- 68210-4137_ee8ba540-74d6-e6fb-e053-2995a90a180f
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Naproxen Sodium
- Dosage form
- TABLET, FILM COATED
- 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 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
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68210-4137-1 | Naproxen Sodium | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 8 |
| 68210-4137-1 | Naproxen Sodium | 10 in 1 BOTTLE | TABLET, FILM COATED | 10 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68210-4137 | NAPROXEN SODIUM TABLET, FILM COATED [SPIRIT PHARMACEUTICALS LLC] | 8 | Legacy NDC, 2 package rows | 20241215_70926898-2315-4097-a0f4-42cdf5edd2d3.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 |
|---|
| 68210-4137-1 | 68210413701 | 1 BOTTLE in 1 CARTON (68210-4137-1) > 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE | 1 bottle | 2021-04-28 | 0000-00-00 | No | No | Current |