Naproxen
- Product NDC
- 10544-010
- 11-digit product format
- 105440010
- Labeler code
- 10544
- Product ID
- 10544-010_fdd1e667-81eb-4023-b70b-5037015f905b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Naproxen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Blenheim Pharmacal, Inc.
- Application
- ANDA074201
- Marketing category
- ANDA
- Marketing start
- 2010-08-19
- Marketing end
- 0000-00-00
- Substance
- NAPROXEN
- Active strength
- 500 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 |
|---|
| 10544-010-20 | Naproxen | 20 in 1 BOTTLE | TABLET | 20 | | 1 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| NAPROXEN | ACTIVE INGREDIENT | 57Y76R9ATQ | NAPROXEN TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
| NAPROXEN | ACTIVE MOIETY | 57Y76R9ATQ | NAPROXEN TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | NAPROXEN TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | NAPROXEN TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | NAPROXEN TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | NAPROXEN TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | NAPROXEN TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | NAPROXEN TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 10544-010 | NAPROXEN TABLET [BLENHEIM PHARMACAL, INC.] | 1 | Legacy NDC, 1 package rows | 20110603_fa5cce05-9850-48ef-8a8b-14a11ccc385a.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 10544-010-20 | 10544001020 | 20 in 1 BOTTLE | Historical |