0378-4386 : Naproxen and Esomeprazole Magnesium Oral Tablet, Film Coated


NDC0378-4386
Labeler: Mylan Pharmaceuticals Inc.
Product Type: Human Prescription Drug
Drug Name:  Naproxen and Esomeprazole Magnesium
Dosage Form: Oral Tablet, Film Coated
Application #: ANDA204920
Rev. Date: 


NDC Package Codes:

  • 0378-4386-91: 60 TABLET, FILM COATED IN 1 BOTTLE, PLASTIC (0378‑4386‑91)

Active Ingredients:

  • Esomeprazole Magnesium
  • Naproxen

Dosage Strength:

  • 20 mg
  • 500 mg

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.
  • 0378-4385 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
  • 55111-289 Naproxen and Esomeprazole Magnesium Oral Tablet, Delayed Release by Dr. Reddy's Laboratories Limited
  • 55111-701 Naproxen and Esomeprazole Magnesium Oral Tablet, Delayed Release by Dr. Reddy's Laboratories Limited
  • 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.