NAPROXEN SODIUM
- Product NDC
- 59105-003
- 11-digit product format
- 591050003
- Labeler code
- 59105
- Product ID
- 59105-003_903b78b4-e647-481e-8c57-aeb1cef51804
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- NAPROXEN SODIUM
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- J.P. BUSINESS ENTERPRISE
- Application
- ANDA090545
- Marketing category
- ANDA
- Marketing start
- 2013-08-20
- Marketing end
- 0000-00-00
- Substance
- NAPROXEN SODIUM
- Active strength
- 220 mg/1
- 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 |
|---|
| 59105-003-15 | NAPROXEN SODIUM | 1 in 1 CARTON | TABLET, FILM COATED, EXTENDED RE | 1 | | 1 |
| 59105-003-15 | NAPROXEN SODIUM | 15 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 15 | | 1 |
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, EXTENDED RELEASE [J.P. BUSINESS ENTERPRISE] | 1 | |
| NAPROXEN | ACTIVE MOIETY | 57Y76R9ATQ | NAPROXEN SODIUM TABLET, FILM COATED, EXTENDED RELEASE [J.P. BUSINESS ENTERPRISE] | 1 | |
| ALUMINUM OXIDE | INACTIVE INGREDIENT | LMI26O6933 | NAPROXEN SODIUM TABLET, FILM COATED, EXTENDED RELEASE [J.P. BUSINESS ENTERPRISE] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | NAPROXEN SODIUM TABLET, FILM COATED, EXTENDED RELEASE [J.P. BUSINESS ENTERPRISE] | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | NAPROXEN SODIUM TABLET, FILM COATED, EXTENDED RELEASE [J.P. BUSINESS ENTERPRISE] | 1 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | NAPROXEN SODIUM TABLET, FILM COATED, EXTENDED RELEASE [J.P. BUSINESS ENTERPRISE] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | NAPROXEN SODIUM TABLET, FILM COATED, EXTENDED RELEASE [J.P. BUSINESS ENTERPRISE] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | NAPROXEN SODIUM TABLET, FILM COATED, EXTENDED RELEASE [J.P. BUSINESS ENTERPRISE] | 1 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | NAPROXEN SODIUM TABLET, FILM COATED, EXTENDED RELEASE [J.P. BUSINESS ENTERPRISE] | 1 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | NAPROXEN SODIUM TABLET, FILM COATED, EXTENDED RELEASE [J.P. BUSINESS ENTERPRISE] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | NAPROXEN SODIUM TABLET, FILM COATED, EXTENDED RELEASE [J.P. BUSINESS ENTERPRISE] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | NAPROXEN SODIUM TABLET, FILM COATED, EXTENDED RELEASE [J.P. BUSINESS ENTERPRISE] | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | NAPROXEN SODIUM TABLET, FILM COATED, EXTENDED RELEASE [J.P. BUSINESS ENTERPRISE] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 59105-003 | NAPROXEN SODIUM TABLET, FILM COATED, EXTENDED RELEASE [J.P. BUSINESS ENTERPRISE] | 1 | Legacy NDC, 2 package rows | 20130822_db2360dc-1608-4eed-a768-797a8d509f68.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 59105-003-15 | 59105000315 | 1 in 1 CARTON | Historical |