NDC 0378-4385

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 Esomeprazole Magnesium; Naproxen.

Product ID0378-4385_34e7c117-7512-442e-bd87-059b09180509
NDC0378-4385
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 NameESOMEPRAZOLE MAGNESIUM; NAPROXEN
Active Ingredient Strength20 mg/1; mg/1
Pharm ClassesAnti-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]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 0378-4385-91

60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-4385-91)
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
27241-202Naproxen and esomeprazole magnesiumNaproxen and esomeprazole magnesium
27241-203Naproxen 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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