Naproxen
- Product NDC
- 43353-506
- 11-digit product format
- 433530506
- Labeler code
- 43353
- Product ID
- 43353-506_8bdbc4d3-bc72-4981-8cc8-92d9b6a0b523
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Naproxen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA075927
- Marketing category
- ANDA
- Marketing start
- 2009-08-10
- Marketing end
- 0000-00-00
- Substance
- NAPROXEN
- Active strength
- 250 mg/1
- Pharmacologic classes
- Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43353-506-60 | Naproxen | 90 in 1 BOTTLE, PLASTIC | TABLET | 90 | | 1 |
| 43353-506-70 | Naproxen | 120 in 1 BOTTLE, PLASTIC | TABLET | 120 | | 1 |
| 43353-506-80 | Naproxen | 180 in 1 BOTTLE, PLASTIC | TABLET | 180 | | 1 |
| 43353-506-94 | Naproxen | 360 in 1 BOTTLE, PLASTIC | TABLET | 360 | | 1 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| NAPROXEN | ACTIVE INGREDIENT | 57Y76R9ATQ | NAPROXEN TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| NAPROXEN | ACTIVE MOIETY | 57Y76R9ATQ | NAPROXEN TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| COLLOIDAL SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | NAPROXEN TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | NAPROXEN TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | NAPROXEN TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | NAPROXEN TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| POVIDONE K30 | INACTIVE INGREDIENT | U725QWY32X | NAPROXEN TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | NAPROXEN TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43353-506 | NAPROXEN TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | Legacy NDC, 4 package rows | 20140708_502f390d-d69e-4a77-8a59-4eedf91004f3.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 43353-506-60 | 43353050660 | 90 in 1 BOTTLE, PLASTIC | Historical |
| 43353-506-70 | 43353050670 | 120 in 1 BOTTLE, PLASTIC | Historical |
| 43353-506-80 | 43353050680 | 180 in 1 BOTTLE, PLASTIC | Historical |
| 43353-506-94 | 43353050694 | 360 in 1 BOTTLE, PLASTIC | Historical |