NDC 0378-4386

Naproxen and Esomeprazole Magnesium

Naproxen And Esomeprazole Magnesium

Naproxen and Esomeprazole Magnesium is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is Naproxen; Esomeprazole Magnesium.

Product ID0378-4386_b975bfdf-b3d3-4c06-94d8-97899a7b5fa9
NDC0378-4386
Product TypeHuman Prescription Drug
Proprietary NameNaproxen and Esomeprazole Magnesium
Generic NameNaproxen And Esomeprazole Magnesium
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2021-11-22
Marketing CategoryANDA /
Application NumberANDA204920
Labeler NameMylan Pharmaceuticals Inc.
Substance NameNAPROXEN; ESOMEPRAZOLE MAGNESIUM
Active Ingredient Strength500 mg/1; mg/1
Pharm ClassesCyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC],Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 0378-4386-91

60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-4386-91)
Marketing Start Date2021-11-22
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "Naproxen and Esomeprazole Magnesium" or generic name "Naproxen And Esomeprazole Magnesium"

NDCBrand NameGeneric Name
0378-4385Naproxen and Esomeprazole Magnesiumnaproxen and esomeprazole magnesium
0378-4386Naproxen and Esomeprazole Magnesiumnaproxen and esomeprazole magnesium
55111-289Naproxen and esomeprazole magnesiumNaproxen and esomeprazole magnesium
55111-701Naproxen and esomeprazole magnesiumNaproxen and esomeprazole magnesium
70748-215NAPROXEN AND ESOMEPRAZOLE MAGNESIUMNAPROXEN AND ESOMEPRAZOLE MAGNESIUM
70748-216NAPROXEN AND ESOMEPRAZOLE MAGNESIUMNAPROXEN AND ESOMEPRAZOLE MAGNESIUM
75987-030VimovoNaproxen and Esomeprazole Magnesium
75987-031VimovoNaproxen and Esomeprazole Magnesium

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