Naproxen Sodium
- Product NDC
- 63874-489
- 11-digit product format
- 638740489
- Labeler code
- 63874
- Product ID
- 63874-489_feb7a143-ac2f-48fd-a2d1-1475337efacf
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Naproxen Sodium
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Altura Pharmaceuticals, Inc.
- Application
- ANDA078314
- Marketing category
- ANDA
- Marketing start
- 2010-01-01
- Marketing end
- 0000-00-00
- Substance
- NAPROXEN SODIUM
- Active strength
- 275 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
- 2017-12-31
- 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 |
|---|
| 63874-489-01 | Naproxen Sodium | 100 in 1 BOTTLE, PLASTIC | TABLET | 100 | | 1 |
| 63874-489-30 | Naproxen Sodium | 30 in 1 BOTTLE, PLASTIC | TABLET | 30 | | 1 |
| 63874-489-60 | Naproxen Sodium | 60 in 1 BOTTLE, PLASTIC | TABLET | 60 | | 1 |
| 63874-489-90 | Naproxen Sodium | 90 in 1 BOTTLE, PLASTIC | TABLET | 90 | | 1 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| NAPROXEN | ACTIVE INGREDIENT | 57Y76R9ATQ | NAPROXEN TABLET NAPROXEN SODIUM TABLET [ALTURA PHARMACEUTICALS, INC.] | 1 | |
| NAPROXEN SODIUM | ACTIVE INGREDIENT | 9TN87S3A3C | NAPROXEN TABLET NAPROXEN SODIUM TABLET [ALTURA PHARMACEUTICALS, INC.] | 1 | |
| NAPROXEN | ACTIVE MOIETY | 57Y76R9ATQ | NAPROXEN TABLET NAPROXEN SODIUM TABLET [ALTURA PHARMACEUTICALS, INC.] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | NAPROXEN TABLET NAPROXEN SODIUM TABLET [ALTURA PHARMACEUTICALS, INC.] | 1 | |
| COLLOIDAL SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | NAPROXEN TABLET NAPROXEN SODIUM TABLET [ALTURA PHARMACEUTICALS, INC.] | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | NAPROXEN TABLET NAPROXEN SODIUM TABLET [ALTURA PHARMACEUTICALS, INC.] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | NAPROXEN TABLET NAPROXEN SODIUM TABLET [ALTURA PHARMACEUTICALS, INC.] | 1 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | NAPROXEN TABLET NAPROXEN SODIUM TABLET [ALTURA PHARMACEUTICALS, INC.] | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | NAPROXEN TABLET NAPROXEN SODIUM TABLET [ALTURA PHARMACEUTICALS, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63874-489 | NAPROXEN TABLET NAPROXEN SODIUM TABLET [ALTURA PHARMACEUTICALS, INC.] | 1 | Legacy NDC, 4 package rows | 20100430_4bbe6e74-b13e-4609-b4cc-aa0b00d66df8.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 63874-489-01 | 63874048901 | 100 in 1 BOTTLE, PLASTIC | Historical |
| 63874-489-30 | 63874048930 | 30 in 1 BOTTLE, PLASTIC | Historical |
| 63874-489-60 | 63874048960 | 60 in 1 BOTTLE, PLASTIC | Historical |
| 63874-489-90 | 63874048990 | 90 in 1 BOTTLE, PLASTIC | Historical |