Naproxen Sodium
- Product NDC
- 10544-063
- 11-digit product format
- 105440063
- Labeler code
- 10544
- Product ID
- 10544-063_ef68a8ac-c8ad-47cd-88dc-1aa2c31601e8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Naproxen Sodium
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Blenheim Pharmacal, Inc.
- Application
- ANDA078314
- Marketing category
- ANDA
- Marketing start
- 2012-01-12
- 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 |
|---|
| 10544-063-20 | Naproxen Sodium | 20 in 1 BOTTLE | TABLET | 20 | | 1 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| NAPROXEN SODIUM | ACTIVE INGREDIENT | 9TN87S3A3C | NAPROXEN SODIUM TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
| NAPROXEN | ACTIVE MOIETY | 57Y76R9ATQ | NAPROXEN SODIUM TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | NAPROXEN SODIUM TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | NAPROXEN SODIUM TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | NAPROXEN SODIUM TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | NAPROXEN SODIUM TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | NAPROXEN SODIUM TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | NAPROXEN SODIUM TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | NAPROXEN SODIUM TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | NAPROXEN SODIUM TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | NAPROXEN SODIUM TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | NAPROXEN SODIUM TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | NAPROXEN SODIUM TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 10544-063 | NAPROXEN SODIUM TABLET [BLENHEIM PHARMACAL, INC.] | 1 | Legacy NDC, 1 package rows | 20151119_d32e840b-c984-4f74-8c0c-ad44fa7a4f36.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 10544-063-20 | 10544006320 | 20 in 1 BOTTLE | Historical |