NAPROXEN
- Product NDC
- 52605-140
- 11-digit product format
- 526050140
- Labeler code
- 52605
- Product ID
- 52605-140_d349356e-61d3-4728-8425-1a4d513605d9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- NAPROXEN
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Polygen Pharmaceuticals LLC
- Application
- ANDA091416
- Marketing category
- ANDA
- Marketing start
- 2012-02-01
- Marketing end
- 0000-00-00
- Substance
- NAPROXEN
- Active strength
- 500 mg/1
- Pharmacologic classes
- Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
- 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#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 52605-140-01 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-6a39-f424-e053-dadaa90a57ce | Naproxen Tablets, USP 250mg, 375mg, 500 mg |
| 52605-140-05 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-6a39-f424-e053-dadaa90a57ce | Naproxen Tablets, USP 250mg, 375mg, 500 mg |
| 52605-140-10 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-6a39-f424-e053-dadaa90a57ce | Naproxen Tablets, USP 250mg, 375mg, 500 mg |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 52605-140-01 | NAPROXEN | 100 in 1 BOTTLE | TABLET | 100 | | 6 |
| 52605-140-05 | NAPROXEN | 500 in 1 BOTTLE | TABLET | 500 | | 6 |
| 52605-140-10 | NAPROXEN | 1000 in 1 BOTTLE | TABLET | 1000 | | 6 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| NAPROXEN | ACTIVE INGREDIENT | 57Y76R9ATQ | NAPROXEN TABLET [POLYGEN PHARMACEUTICALS LLC] | 6 | |
| NAPROXEN | ACTIVE MOIETY | 57Y76R9ATQ | NAPROXEN TABLET [POLYGEN PHARMACEUTICALS LLC] | 6 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | NAPROXEN TABLET [POLYGEN PHARMACEUTICALS LLC] | 6 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | NAPROXEN TABLET [POLYGEN PHARMACEUTICALS LLC] | 6 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | NAPROXEN TABLET [POLYGEN PHARMACEUTICALS LLC] | 6 | |
| NAPROXEN | ACTIVE INGREDIENT | 57Y76R9ATQ | NAPROXEN TABLET [BLENHEIM PHARMACAL, INC.] | 2 | |
| NAPROXEN | ACTIVE MOIETY | 57Y76R9ATQ | NAPROXEN TABLET [BLENHEIM PHARMACAL, INC.] | 2 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | NAPROXEN TABLET [BLENHEIM PHARMACAL, INC.] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | NAPROXEN TABLET [BLENHEIM PHARMACAL, INC.] | 2 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | NAPROXEN TABLET [BLENHEIM PHARMACAL, INC.] | 2 | |
| NAPROXEN | ACTIVE INGREDIENT | 57Y76R9ATQ | NAPROXEN TABLET [DISPENSING SOLUTIONS, INC.] | 1 | |
| NAPROXEN | ACTIVE MOIETY | 57Y76R9ATQ | NAPROXEN TABLET [DISPENSING SOLUTIONS, INC.] | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | NAPROXEN TABLET [DISPENSING SOLUTIONS, INC.] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | NAPROXEN TABLET [DISPENSING SOLUTIONS, INC.] | 1 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | NAPROXEN TABLET [DISPENSING SOLUTIONS, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 52605-140 | NAPROXEN TABLET [POLYGEN PHARMACEUTICALS LLC] | 6 | Legacy NDC, 3 package rows | 20130628_2e84d479-5536-471f-93ef-34c353aff071.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 52605-140-01 | 52605014001 | 100 in 1 BOTTLE | Historical |
| 52605-140-05 | 52605014005 | 500 in 1 BOTTLE | Historical |
| 52605-140-10 | 52605014010 | 1000 in 1 BOTTLE | Historical |