Naproxen Sodium
- Product NDC
- 58517-300
- 11-digit product format
- 585170300
- Labeler code
- 58517
- Product ID
- 58517-300_75e40f0f-246e-457d-a4f4-8984a620feef
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Naproxen Sodium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- New Horizon Rx Group, LLC
- Application
- ANDA078432
- Marketing category
- ANDA
- Marketing start
- 2013-08-25
- Marketing end
- 0000-00-00
- Substance
- NAPROXEN SODIUM
- Active strength
- 550 mg/1
- Pharmacologic classes
- Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]
- NDC exclude flag
- E
- Listing certified through
- 2018-12-31
- 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 |
|---|
| 58517-300-30 | Naproxen Sodium | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 6 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| NAPROXEN SODIUM | ACTIVE INGREDIENT | 9TN87S3A3C | NAPROXEN SODIUM TABLET, FILM COATED [NEW HORIZON RX GROUP, LLC] | 6 | |
| NAPROXEN | ACTIVE MOIETY | 57Y76R9ATQ | NAPROXEN SODIUM TABLET, FILM COATED [NEW HORIZON RX GROUP, LLC] | 6 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | NAPROXEN SODIUM TABLET, FILM COATED [NEW HORIZON RX GROUP, LLC] | 6 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | NAPROXEN SODIUM TABLET, FILM COATED [NEW HORIZON RX GROUP, LLC] | 6 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | NAPROXEN SODIUM TABLET, FILM COATED [NEW HORIZON RX GROUP, LLC] | 6 | |
| POLYVINYL ALCOHOL | INACTIVE INGREDIENT | 532B59J990 | NAPROXEN SODIUM TABLET, FILM COATED [NEW HORIZON RX GROUP, LLC] | 6 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | NAPROXEN SODIUM TABLET, FILM COATED [NEW HORIZON RX GROUP, LLC] | 6 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | NAPROXEN SODIUM TABLET, FILM COATED [NEW HORIZON RX GROUP, LLC] | 6 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | NAPROXEN SODIUM TABLET, FILM COATED [NEW HORIZON RX GROUP, LLC] | 6 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 58517-300 | NAPROXEN SODIUM TABLET, FILM COATED [NEW HORIZON RX GROUP, LLC] | 6 | Legacy NDC, 1 package rows | 20140101_21e6c0e1-10e8-4f0f-907d-3a514f7299fc.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 58517-300-30 | 58517030030 | 30 in 1 BOTTLE | Historical |