NAPROXEN SODIUM
- Product NDC
- 68210-4096
- 11-digit product format
- 682104096
- Labeler code
- 68210
- Product ID
- 68210-4096_2a8235d0-4618-0572-e063-6394a90a0d1a
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- NAPROXEN SODIUM
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- SPIRIT PHARMACEUTICALS,LLC
- Application
- ANDA091353
- Marketing category
- ANDA
- Marketing start
- 2020-07-02
- 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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68210-4096-1 | NAPROXEN SODIUM | 365 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 365 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68210-4096 | NAPROXEN SODIUM TABLET, FILM COATED, EXTENDED RELEASE [SPIRIT PHARMACEUTICALS,LLC] | 7 | Current NDC, Legacy NDC, 1 package rows | 20250101_a690dc39-95f2-4853-a291-05d7dc9a1551.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68210-4096-1 | 68210409601 | 365 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68210-4096-1) | 2020-07-02 | 0000-00-00 | No | No | Current |