Naproxen sodium
- Product NDC
- 0480-0952
- 11-digit product format
- 004800952
- Labeler code
- 0480
- Product ID
- 0480-0952_6d02cbbb-bfb4-4c68-8a7b-4207f6f9cfbb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- naproxen sodium
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Teva Pharmaceuticals, Inc.
- Application
- ANDA075416
- Marketing category
- ANDA
- Marketing start
- 2022-11-01
- Substance
- NAPROXEN SODIUM
- Active strength
- 500 mg/1
- Pharmacologic classes
- Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
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 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0480-0952-58 | Naproxen sodium | 75 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 75 | 6 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0480-0952-58 | EA - Each | 0480-0952 | 85ec614f-751d-41ff-bce3-79adba45da11 | 1 | 2022-12-07 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0480-0952 | NAPROXEN SODIUM TABLET, FILM COATED, EXTENDED RELEASE NAPROXEN SODIUM TABLET, FILM COATED, EXTENDED RELEASE [TEVA PHARMACEUTICALS, INC.] | 6 | Current NDC, Legacy NDC, 1 package rows | 20250123_826fd9e3-22fe-408b-820c-f2b710189555.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1116320 | naproxen sodium 375 MG 24HR Extended Release Oral Tablet | PSN | 826fd9e3-22fe-408b-820c-f2b710189555 | 6 |
| 1116339 | naproxen sodium 500 MG 24HR Extended Release Oral Tablet | PSN | 826fd9e3-22fe-408b-820c-f2b710189555 | 6 |
| 1116349 | naproxen sodium 750 MG 24HR Extended Release Oral Tablet | PSN | 826fd9e3-22fe-408b-820c-f2b710189555 | 6 |
| 1116320 | 24 HR naproxen 375 MG Extended Release Oral Tablet | SCD | 826fd9e3-22fe-408b-820c-f2b710189555 | 6 |
| 1116339 | 24 HR naproxen 500 MG Extended Release Oral Tablet | SCD | 826fd9e3-22fe-408b-820c-f2b710189555 | 6 |
| 1116349 | 24 HR naproxen 750 MG Extended Release Oral Tablet | SCD | 826fd9e3-22fe-408b-820c-f2b710189555 | 6 |
| 1116320 | naproxen 375 MG (naproxen sodium 413 MG) 24 HR Extended Release Oral Tablet | SY | 826fd9e3-22fe-408b-820c-f2b710189555 | 6 |
| 1116339 | naproxen 500 MG (naproxen sodium 550 MG) 24 HR Extended Release Oral Tablet | SY | 826fd9e3-22fe-408b-820c-f2b710189555 | 6 |
| 1116349 | naproxen 750 MG (as naproxen sodium 825 MG) 24 HR Extended Release Oral Tablet | SY | 826fd9e3-22fe-408b-820c-f2b710189555 | 6 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 0480-0952-58 | 00480095258 | 75 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0480-0952-58) | 2022-11-01 | 0000-00-00 | No | No | Current |