Naproxen
- Product NDC
- 43353-211
- 11-digit product format
- 433530211
- Labeler code
- 43353
- Product ID
- 43353-211_68ef14c5-d88d-4c95-b6d4-65606f4c11fa
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Naproxen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA091305
- Marketing category
- ANDA
- Marketing start
- 2016-06-10
- 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 |
|---|
| 43353-211-53 | Naproxen | 60 in 1 BOTTLE | TABLET | 60 | | 2 |
| 43353-211-70 | Naproxen | 120 in 1 BOTTLE | TABLET | 120 | | 2 |
| 43353-211-80 | Naproxen | 180 in 1 BOTTLE | TABLET | 180 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43353-211 | NAPROXEN TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | Current NDC, Legacy NDC, 3 package rows | 20171026_e2347581-90da-429a-b17c-cffd0039fb86.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 |
|---|
| 43353-211-53 | 43353021153 | 60 TABLET in 1 BOTTLE (43353-211-53) | 60 tablet | 2016-08-18 | 0000-00-00 | No | No | Current |
| 43353-211-70 | 43353021170 | 120 TABLET in 1 BOTTLE (43353-211-70) | 120 tablet | 2016-08-18 | 0000-00-00 | No | No | Current |
| 43353-211-80 | 43353021180 | 180 TABLET in 1 BOTTLE (43353-211-80) | 180 tablet | 2016-08-18 | 0000-00-00 | No | No | Current |