Naproxen
- Product NDC
- 65862-521
- 11-digit product format
- 658620521
- Labeler code
- 65862
- Product ID
- 65862-521_51d52d13-f5c1-4e80-8cb9-4aa72ad94103
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Naproxen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA200429
- Marketing category
- ANDA
- Marketing start
- 2011-11-08
- Substance
- NAPROXEN
- 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
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| NAPROXEN | 375 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 57Y76R9ATQ |
| Rxcui | 198012, 198013, 198014 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 65862-521-01 | Naproxen | 100 in 1 BOTTLE | TABLET | 100 | | 16 |
| 65862-521-05 | Naproxen | 500 in 1 BOTTLE | TABLET | 500 | | 16 |
| 65862-521-99 | Naproxen | 1000 in 1 BOTTLE | TABLET | 1000 | | 16 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65862-521 | NAPROXEN TABLET [AUROBINDO PHARMA LIMITED] | 15 | Current NDC, Legacy NDC, 3 package rows | 20241213_0e5315bc-c02f-4749-be69-b5b528327d58.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 |
|---|
| 65862-521-01 | 65862052101 | 100 TABLET in 1 BOTTLE (65862-521-01) | 100 tablet | 2011-11-08 | 0000-00-00 | No | No | Current |
| 65862-521-05 | 65862052105 | 500 TABLET in 1 BOTTLE (65862-521-05) | 500 tablet | 2011-11-08 | 0000-00-00 | No | No | Current |
| 65862-521-39 | 65862052139 | 3000 TABLET in 1 BAG (65862-521-39) | 3000 tablet | 08-NOV-11 | | | | Current |
| 65862-521-99 | 65862052199 | 1000 TABLET in 1 BOTTLE (65862-521-99) | 1000 tablet | 2011-11-08 | 0000-00-00 | No | No | Current |