Naproxen Sodium
- Product NDC
- 43598-058
- 11-digit product format
- 435980058
- Labeler code
- 43598
- Product ID
- 43598-058_4c8d85dc-7bf0-a540-f37f-d1f91ff908f9
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Naproxen Sodium
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- Dr Reddy's Laboratories Inc
- Application
- ANDA075168
- Marketing category
- ANDA
- Marketing start
- 2021-08-04
- 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
- Brand name suffix
- Caplets
- 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 |
|---|
| 43598-058-29 | Naproxen Sodium Caplets | 200 in 1 BOTTLE | TABLET, COATED | 200 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43598-058 | NAPROXEN SODIUM CAPLETS (NAPROXEN SODIUM) TABLET, COATED [DR REDDY'S LABORATORIES INC] | 4 | Current NDC, Legacy NDC, 1 package rows | 20241203_ee0463bc-e939-1ecf-5a86-d045c426fecf.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 43598-058-29 | 43598005829 | 200 TABLET, COATED in 1 BOTTLE (43598-058-29) | 2021-08-04 | 0000-00-00 | No | No | Current |