NAPROXEN SODIUM
- Product NDC
- 49483-608
- 11-digit product format
- 494830608
- Labeler code
- 49483
- Product ID
- 49483-608_0538c5c7-c559-4ea9-e063-6294a90aec21
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- NAPROXEN SODIUM
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- TIME CAP LABORATORIES, INC
- Application
- ANDA090545
- Marketing category
- ANDA
- Marketing start
- 2016-03-28
- 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 |
| Rxcui | 849574 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 49483-608-00 | NAPROXEN SODIUM | 6500 in 1 BAG | TABLET, FILM COATED | 6500 | | 4 |
| 49483-608-01 | NAPROXEN SODIUM | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 4 |
| 49483-608-05 | NAPROXEN SODIUM | 50 in 1 BOTTLE | TABLET, FILM COATED | 50 | | 4 |
| 49483-608-31 | NAPROXEN SODIUM | 300 in 1 BOTTLE | TABLET, FILM COATED | 300 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 49483-608 | NAPROXEN SODIUM TABLET, FILM COATED [TIME CAP LABORATORIES, INC] | 4 | Current NDC, Legacy NDC, 4 package rows | 20230913_ab7b7b8e-923b-4dc1-812c-78e85de1bee1.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 |
|---|
| 49483-608-00 | 49483060800 | 6500 TABLET, FILM COATED in 1 BAG (49483-608-00) | 2016-03-28 | 0000-00-00 | No | No | Current |
| 49483-608-01 | 49483060801 | 100 TABLET, FILM COATED in 1 BOTTLE (49483-608-01) | 2016-03-28 | 0000-00-00 | No | No | Current |
| 49483-608-05 | 49483060805 | 50 TABLET, FILM COATED in 1 BOTTLE (49483-608-05) | 2016-03-28 | 0000-00-00 | No | No | Current |
| 49483-608-31 | 49483060831 | 300 TABLET, FILM COATED in 1 BOTTLE (49483-608-31) | 2023-08-08 | | No | No | Current |