Naproxen sodium
- Product NDC
- 43598-495
- 11-digit product format
- 435980495
- Labeler code
- 43598
- Product ID
- 43598-495_3498dec1-32e7-ecde-c86e-4c1d7cb0b080
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Naproxen sodium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Dr. Reddy's Laboratories Inc.
- Application
- ANDA078486
- Marketing category
- ANDA
- Marketing start
- 2016-04-26
- Substance
- NAPROXEN SODIUM
- Active strength
- 550 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 | 550 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 9TN87S3A3C |
| Rxcui | 849398, 849431 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43598-495-01 | Naproxen sodium | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 12 |
| 43598-495-05 | Naproxen sodium | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 12 |
| 43598-495-10 | Naproxen sodium | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 12 |
| 43598-495-30 | Naproxen sodium | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 12 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43598-495 | NAPROXEN SODIUM TABLET, FILM COATED [DR. REDDY'S LABORATORIES INC.] | 10 | Current NDC, Legacy NDC, 4 package rows | 20240724_37de42a6-701b-7f6e-e631-519e2ea78b54.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 |
|---|
| 43598-495-01 | 43598049501 | 100 TABLET, FILM COATED in 1 BOTTLE (43598-495-01) | 2016-04-26 | 0000-00-00 | No | No | Current |
| 43598-495-05 | 43598049505 | 500 TABLET, FILM COATED in 1 BOTTLE (43598-495-05) | 2016-04-26 | 0000-00-00 | No | No | Current |
| 43598-495-10 | 43598049510 | 1000 TABLET, FILM COATED in 1 BOTTLE (43598-495-10) | 2016-04-26 | 0000-00-00 | No | No | Current |
| 43598-495-30 | 43598049530 | 30 TABLET, FILM COATED in 1 BOTTLE (43598-495-30) | 2016-04-26 | 0000-00-00 | No | No | Current |