Naproxen Sodium
- Product NDC
- 53746-193
- 11-digit product format
- 537460193
- Labeler code
- 53746
- Product ID
- 53746-193_58c84756-9886-4cfa-937c-f8894064c606
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Naproxen Sodium
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals of New York LLC
- Application
- ANDA078432
- Marketing category
- ANDA
- Marketing start
- 2007-04-26
- Marketing end
- 0000-00-00
- Substance
- NAPROXEN SODIUM
- Active strength
- 275 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
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| fef6ad89-235f-4274-ba49-a8e53642473e | Product name | 2 | 20250225 |
| 594e2c86-3079-4e6e-96c9-48f7a8afc78d | Product name | 1 | 20230718 |
| 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 |
|---|---|---|---|---|---|
| 53746-193-01 | 2021-02-17 | C162847 | 48780-1 | ba0f9c33-4722-a910-e053-dadaa90a0b85 | 3c55594c-7801-4f59-8f4f-e85a03f3776b |
| 53746-193-05 | 2021-02-17 | C162847 | 48780-1 | ba0f9c33-4722-a910-e053-dadaa90a0b85 | 3c55594c-7801-4f59-8f4f-e85a03f3776b |
| 53746-193-01 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-4722-a910-e053-dadaa90a0b85 | 3c55594c-7801-4f59-8f4f-e85a03f3776b |
| 53746-193-05 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-4722-a910-e053-dadaa90a0b85 | 3c55594c-7801-4f59-8f4f-e85a03f3776b |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 849398 | naproxen sodium 275 MG Oral Tablet | PSN | 117b20fa-6ccc-5852-e054-00144ff88e88 | 1 |
| 849398 | naproxen sodium 275 MG Oral Tablet | PSN | 30cc16cd-720d-4baa-8941-bfdc28b62b04 | 1 |
| 849431 | naproxen sodium 550 MG Oral Tablet | PSN | 30cc16cd-720d-4baa-8941-bfdc28b62b04 | 1 |
| 849398 | naproxen sodium 275 MG Oral Tablet | SCD | 117b20fa-6ccc-5852-e054-00144ff88e88 | 1 |
| 849398 | naproxen sodium 275 MG Oral Tablet | SCD | 30cc16cd-720d-4baa-8941-bfdc28b62b04 | 1 |
| 849431 | naproxen sodium 550 MG Oral Tablet | SCD | 30cc16cd-720d-4baa-8941-bfdc28b62b04 | 1 |
| 849398 | naproxen sodium 275 MG (as naproxen 250 MG) Oral Tablet | SY | 117b20fa-6ccc-5852-e054-00144ff88e88 | 1 |
| 849398 | naproxen sodium 275 MG (as naproxen 250 MG) Oral Tablet | SY | 30cc16cd-720d-4baa-8941-bfdc28b62b04 | 1 |
| 849431 | naproxen sodium 550 MG (as naproxen 500 MG) Oral Tablet | SY | 30cc16cd-720d-4baa-8941-bfdc28b62b04 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 53746-193-01 | 53746019301 | 100 TABLET in 1 BOTTLE (53746-193-01) | 100 tablet | 2007-04-26 | 0000-00-00 | No | No | Current |
| 53746-193-05 | 53746019305 | 500 TABLET in 1 BOTTLE (53746-193-05) | 500 tablet | 2007-04-26 | 0000-00-00 | No | No | Current |