Naproxen
- Product NDC
- 69097-852
- 11-digit product format
- 690970852
- Labeler code
- 69097
- Product ID
- 69097-852_dcfba184-4397-4934-9392-2ac42f65e9e5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Naproxen
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Cipla USA Inc.
- Application
- ANDA091432
- Marketing category
- ANDA
- Marketing start
- 2016-07-05
- Substance
- NAPROXEN
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Naproxen
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| NAPROXEN | 500 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 57Y76R9ATQ |
| Rxcui | 311915, 603103 |
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 |
|---|---|---|---|---|---|---|
| 69097-852-07 | Naproxen | 100 in 1 BOTTLE | TABLET, DELAYED RELEASE | 100 | 4 | |
| 69097-852-12 | Naproxen | 500 in 1 BOTTLE | TABLET, DELAYED RELEASE | 500 | 4 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 311915 | naproxen 500 MG Delayed Release Oral Tablet | PSN | 2d01e583-670a-46f4-b5f2-3fad46d0376f | 10 |
| 311915 | naproxen 500 MG Delayed Release Oral Tablet | SCD | 2d01e583-670a-46f4-b5f2-3fad46d0376f | 10 |
| 311915 | naproxen (as naproxen sodium) 500 MG Delayed Release Oral Tablet | SY | 2d01e583-670a-46f4-b5f2-3fad46d0376f | 10 |
| 603103 | naproxen 375 MG Delayed Release Oral Tablet | PSN | e06c2b43-9882-442e-8413-10d9a33aecb9 | 4 |
| 311915 | naproxen 500 MG Delayed Release Oral Tablet | PSN | 5e873524-f9fb-fe2d-e053-2991aa0aa0a5 | 4 |
| 311915 | naproxen 500 MG Delayed Release Oral Tablet | PSN | e06c2b43-9882-442e-8413-10d9a33aecb9 | 4 |
| 603103 | naproxen 375 MG Delayed Release Oral Tablet | SCD | e06c2b43-9882-442e-8413-10d9a33aecb9 | 4 |
| 311915 | naproxen 500 MG Delayed Release Oral Tablet | SCD | 5e873524-f9fb-fe2d-e053-2991aa0aa0a5 | 4 |
| 311915 | naproxen 500 MG Delayed Release Oral Tablet | SCD | e06c2b43-9882-442e-8413-10d9a33aecb9 | 4 |
| 311915 | naproxen (as naproxen sodium) 500 MG Delayed Release Oral Tablet | SY | 5e873524-f9fb-fe2d-e053-2991aa0aa0a5 | 4 |
| 311915 | naproxen (as naproxen sodium) 500 MG Delayed Release Oral Tablet | SY | e06c2b43-9882-442e-8413-10d9a33aecb9 | 4 |
| 603103 | naproxen 375 MG (as naproxen sodium 413 MG) Delayed Release Oral Tablet | SY | e06c2b43-9882-442e-8413-10d9a33aecb9 | 4 |
| 311915 | naproxen 500 MG Delayed Release Oral Tablet | PSN | 5f51e6ed-82dd-450e-9e39-cb11a853bc74 | 3 |
| 311915 | naproxen 500 MG Delayed Release Oral Tablet | SCD | 5f51e6ed-82dd-450e-9e39-cb11a853bc74 | 3 |
| 311915 | naproxen (as naproxen sodium) 500 MG Delayed Release Oral Tablet | SY | 5f51e6ed-82dd-450e-9e39-cb11a853bc74 | 3 |
| 311915 | naproxen 500 MG Delayed Release Oral Tablet | PSN | f60e3860-dfa7-4154-aa2f-65db740bf097 | 1 |
| 311915 | naproxen 500 MG Delayed Release Oral Tablet | PSN | c89df567-5228-4073-a139-71ee22cf359b | 1 |
| 311915 | naproxen 500 MG Delayed Release Oral Tablet | SCD | f60e3860-dfa7-4154-aa2f-65db740bf097 | 1 |
| 311915 | naproxen 500 MG Delayed Release Oral Tablet | SCD | c89df567-5228-4073-a139-71ee22cf359b | 1 |
| 311915 | naproxen (as naproxen sodium) 500 MG Delayed Release Oral Tablet | SY | f60e3860-dfa7-4154-aa2f-65db740bf097 | 1 |
| 311915 | naproxen (as naproxen sodium) 500 MG Delayed Release Oral Tablet | SY | c89df567-5228-4073-a139-71ee22cf359b | 1 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 69097-852-07 | 69097085207 | 100 TABLET, DELAYED RELEASE in 1 BOTTLE (69097-852-07) | 2016-07-05 | 0000-00-00 | No | No | Current |
| 69097-852-12 | 69097085212 | 500 TABLET, DELAYED RELEASE in 1 BOTTLE (69097-852-12) | 2016-07-05 | 0000-00-00 | No | No | Current |