55111-289 : Naproxen and Esomeprazole Magnesium Oral Tablet, Delayed Release
| NDC: | 55111-289 |
| Labeler: | Dr. Reddy's Laboratories Limited |
| Product Type: | Human Prescription Drug |
| Drug Name: |  Naproxen and Esomeprazole Magnesium |
| Dosage Form: | Oral Tablet, Delayed Release |
| Application #: | ANDA204206 |
| Rev. Date: |
Appearance:
| Markings: | R289 |
| Shapes: |
Capsule |
| Colors: |
 White |
| Size (mm): | 16 |
| Segments: * | 1 |
* Segments = the number of equally sized pieces which the pill can be broken into. In this case, a value of 1 indicates a solid pill with no score lines. | |
NDC Package Codes:
- 55111-289-60: 60 TABLET, DELAYED RELEASE IN 1 BOTTLE (55111‑289‑60)
Active Ingredients:
- Naproxen
- Esomeprazole Magnesium
Dosage Strength:
- 375 mg
- 20 mg
Inactive Ingredients:
- Croscarmellose Sodium
- Ferric Oxide Yellow
- Ferrosoferric Oxide
- Hypromellose 2910 (3 Mpa.s)
- Hypromellose 2910 (5 Mpa.s)
- Ammonia
- Lactose Monohydrate
- Magnesium Oxide
- Magnesium Stearate
- Methacrylic Acid - Ethyl Acrylate Copolymer (1:1) Type a
- Propylene Glycol
- Shellac
- Polyethylene Glycol 400
- Poloxamer 188
- Povidone K90
- Sodium Hydroxide
- Triethyl Citrate
- Talc
- Titanium Dioxide
- Sodium Lauryl Sulfate
- Silicon Dioxide /
Pharmaceutical Classes:
- Anti-Inflammatory Agents
- Non-Steroidal [CS]
- Cyclooxygenase Inhibitors [MoA]
- Cytochrome P450 2C19 Inhibitors [MoA]
- Nonsteroidal Anti-inflammatory Drug [EPC]
- Proton Pump Inhibitor [EPC]
- Proton Pump Inhibitors [MoA]
Related Products:
Based on records with the same trade name.- 55111-701 Naproxen and Esomeprazole Magnesium Oral Tablet, Delayed Release by Dr. Reddy's Laboratories Limited
- 0378-4385 Naproxen and Esomeprazole Magnesium Oral Tablet, Film Coated by Mylan Pharmaceuticals Inc.
- 0378-4386 Naproxen and Esomeprazole Magnesium Oral Tablet, Film Coated by Mylan Pharmaceuticals Inc.
- 27241-202 Naproxen and Esomeprazole Magnesium Oral Tablet, Delayed Release by Ajanta Pharma USA Inc.
- 27241-203 Naproxen and Esomeprazole Magnesium Oral Tablet, Delayed Release by Ajanta Pharma USA Inc.
- 50228-437 Naproxen and Esomeprazole Magnesium Oral Tablet, Delayed Release by Sciegen Pharmaceuticals, Inc
- 50228-438 Naproxen and Esomeprazole Magnesium Oral Tablet, Delayed Release by Sciegen Pharmaceuticals, Inc
- 70748-215 Naproxen and Esomeprazole Magnesium Oral Tablet, Delayed Release by Lupin Pharmaceuticals, Inc.
- 70748-216 Naproxen and Esomeprazole Magnesium Oral Tablet, Delayed Release by Lupin Pharmaceuticals, Inc.
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Note: The RxChat NDC Database uses publicly available data from the FDA and the U.S. National Library of Medicine (NLM); The NLM is not responsible for the data presented and does not endorse or recommend this or any other product. While we make every effort to ensure that the information presented is accurate, you should assume that all results are unvalidated. To report any errors or inconsistencies please contact us.