NAPROXEN
- Product NDC
- 52605-138
- 11-digit product format
- 526050138
- Labeler code
- 52605
- Product ID
- 52605-138_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
- 250 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#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| fef6ad89-235f-4274-ba49-a8e53642473e | Product name | 2 | 20250225 |
| 87fed3e6-8fba-48ef-96b0-3a7fb54b96ff | Product name | 3 | 20230306 |
| b5fdaaec-7251-4da6-9cb2-4e9e76939ec8 | Product name | 1 | 20200623 |
| e76dbbc1-775d-722c-08ff-ed45e8a80def | Product name | 3 | 20181002 |
| 6f4f4521-fd56-1ae6-888b-3b021bd75c7c | Product name | 1 | 20140508 |
| ce67e27d-1d21-5465-4409-b0662dd99d4d | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 52605-138-01 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-6a39-f424-e053-dadaa90a57ce | Naproxen Tablets, USP 250mg, 375mg, 500 mg |
| 52605-138-05 | 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 | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 52605-138-01 | NAPROXEN | 100 in 1 BOTTLE | TABLET | 100 | 6 | |
| 52605-138-05 | NAPROXEN | 500 in 1 BOTTLE | TABLET | 500 | 6 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 52605-138-05 | EA - Each | 52605-138 | 55f996bf-19f5-49cd-bf6d-c0a4bc351279 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| 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 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 198013 | naproxen 250 MG Oral Tablet | PSN | 2e84d479-5536-471f-93ef-34c353aff071 | 6 |
| 198012 | naproxen 375 MG Oral Tablet | PSN | 2e84d479-5536-471f-93ef-34c353aff071 | 6 |
| 198014 | naproxen 500 MG Oral Tablet | PSN | 2e84d479-5536-471f-93ef-34c353aff071 | 6 |
| 198013 | naproxen 250 MG Oral Tablet | SCD | 2e84d479-5536-471f-93ef-34c353aff071 | 6 |
| 198012 | naproxen 375 MG Oral Tablet | SCD | 2e84d479-5536-471f-93ef-34c353aff071 | 6 |
| 198014 | naproxen 500 MG Oral Tablet | SCD | 2e84d479-5536-471f-93ef-34c353aff071 | 6 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 52605-138-01 | 52605013801 | 100 in 1 BOTTLE | Historical |
| 52605-138-05 | 52605013805 | 500 in 1 BOTTLE | Historical |