Naproxen Sodium
- Product NDC
- 33358-259
- 11-digit product format
- 333580259
- Labeler code
- 33358
- Product ID
- 33358-259_e68706af-547f-4a60-8dc7-25e8f09e36dd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Naproxen Sodium
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- RxChange Co.
- Application
- ANDA078432
- Marketing category
- ANDA
- Marketing start
- 2014-11-11
- Marketing end
- 0000-00-00
- Substance
- NAPROXEN SODIUM
- Active strength
- 550 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#
| 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 |
|---|---|---|---|---|---|
| 33358-259-00 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-1611-f424-e053-dadaa90a57ce | Naproxen Sodium Tablets, USP 275 mg and 550 mg |
| 33358-259-30 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-1611-f424-e053-dadaa90a57ce | Naproxen Sodium Tablets, USP 275 mg and 550 mg |
| 33358-259-60 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-1611-f424-e053-dadaa90a57ce | Naproxen Sodium Tablets, USP 275 mg and 550 mg |
| 33358-259-90 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-1611-f424-e053-dadaa90a57ce | Naproxen Sodium Tablets, USP 275 mg and 550 mg |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 33358-259-00 | Naproxen Sodium | 100 in 1 BOTTLE | TABLET | 100 | 2 | |
| 33358-259-30 | Naproxen Sodium | 30 in 1 BOTTLE | TABLET | 30 | 2 | |
| 33358-259-60 | Naproxen Sodium | 60 in 1 BOTTLE | TABLET | 60 | 2 | |
| 33358-259-90 | Naproxen Sodium | 90 in 1 BOTTLE | TABLET | 90 | 2 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 33358-259-00 | EA - Each | 33358-259 | 0fba164e-efff-4d76-9d9b-fd32d9b32fae | 1 | 2014-12-01 |
| 33358-259-30 | EA - Each | 33358-259 | 55cce4b3-984e-4c91-a6df-123cd22a0a82 | 1 | 2014-12-01 |
| 33358-259-60 | EA - Each | 33358-259 | cb9f2dc9-fddf-45d7-a09b-225da8372ea0 | 1 | 2014-12-01 |
| 33358-259-90 | EA - Each | 33358-259 | 814efca9-9f0a-4ffd-a891-a9d73023f174 | 1 | 2015-03-03 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| NAPROXEN SODIUM | ACTIVE INGREDIENT | 9TN87S3A3C | NAPROXEN SODIUM TABLET [RXCHANGE CO.] | 2 | |
| NAPROXEN | ACTIVE MOIETY | 57Y76R9ATQ | NAPROXEN SODIUM TABLET [RXCHANGE CO.] | 2 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | NAPROXEN SODIUM TABLET [RXCHANGE CO.] | 2 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | NAPROXEN SODIUM TABLET [RXCHANGE CO.] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | NAPROXEN SODIUM TABLET [RXCHANGE CO.] | 2 | |
| POLYVINYL ALCOHOL | INACTIVE INGREDIENT | 532B59J990 | NAPROXEN SODIUM TABLET [RXCHANGE CO.] | 2 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | NAPROXEN SODIUM TABLET [RXCHANGE CO.] | 2 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | NAPROXEN SODIUM TABLET [RXCHANGE CO.] | 2 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | NAPROXEN SODIUM TABLET [RXCHANGE CO.] | 2 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 849431 | naproxen sodium 550 MG Oral Tablet | PSN | ab88c208-6178-41cf-a6f1-88063e340f39 | 2 |
| 849431 | naproxen sodium 550 MG Oral Tablet | SCD | ab88c208-6178-41cf-a6f1-88063e340f39 | 2 |
| 849431 | naproxen sodium 550 MG (as naproxen 500 MG) Oral Tablet | SY | ab88c208-6178-41cf-a6f1-88063e340f39 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 33358-259-00 | 33358025900 | 100 in 1 BOTTLE | Historical |
| 33358-259-30 | 33358025930 | 30 in 1 BOTTLE | Historical |
| 33358-259-60 | 33358025960 | 60 in 1 BOTTLE | Historical |
| 33358-259-90 | 33358025990 | 90 in 1 BOTTLE | Historical |