NAPROXEN
- Product NDC
- 49483-618
- 11-digit product format
- 494830618
- Labeler code
- 49483
- Product ID
- 49483-618_77d2030d-4699-2117-e053-2a91aa0a6dc8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- NAPROXEN
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- TIME CAP LABORATORIES
- Application
- ANDA091416
- Marketing category
- ANDA
- Marketing start
- 2016-07-06
- Substance
- NAPROXEN
- Active strength
- 500 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 | 500 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 |
|---|
| 49483-618-01 | NAPROXEN | 100 in 1 BOTTLE, PLASTIC | TABLET | 100 | | 4 |
| 49483-618-50 | NAPROXEN | 500 in 1 BOTTLE, PLASTIC | TABLET | 500 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 49483-618 | NAPROXEN TABLET [TIME CAP LABORATORIES] | 4 | Current NDC, Legacy NDC, 2 package rows | 20181010_4350a2d9-5228-460e-b7b1-27e8fa846787.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 |
|---|
| 49483-618-01 | 49483061801 | 100 TABLET in 1 BOTTLE, PLASTIC (49483-618-01) | 100 tablet | 2016-07-06 | 0000-00-00 | No | No | Current |
| 49483-618-50 | 49483061850 | 500 TABLET in 1 BOTTLE, PLASTIC (49483-618-50) | 500 tablet | 2016-07-06 | 0000-00-00 | No | No | Current |