NDC 55111-289

Naproxen and esomeprazole magnesium

Naproxen And Esomeprazole Magnesium

Naproxen and esomeprazole magnesium is a Oral Tablet, Delayed Release in the Human Prescription Drug category. It is labeled and distributed by Dr. Reddy's Laboratories Limited. The primary component is Naproxen; Esomeprazole Magnesium.

Product ID55111-289_16cb9567-8fe1-3739-2ec0-a05c3d98dddf
NDC55111-289
Product TypeHuman Prescription Drug
Proprietary NameNaproxen and esomeprazole magnesium
Generic NameNaproxen And Esomeprazole Magnesium
Dosage FormTablet, Delayed Release
Route of AdministrationORAL
Marketing Start Date2020-02-18
Marketing CategoryANDA / ANDA
Application NumberANDA204206
Labeler NameDr. Reddy's Laboratories Limited
Substance NameNAPROXEN; ESOMEPRAZOLE MAGNESIUM
Active Ingredient Strength375 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 Through2021-12-31

Packaging

NDC 55111-289-60

60 TABLET, DELAYED RELEASE in 1 BOTTLE (55111-289-60)
Marketing Start Date2020-02-18
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55111-289-60 [55111028960]

Naproxen and esomeprazole magnesium TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA204206
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2020-02-18

Drug Details

Active Ingredients

IngredientStrength
NAPROXEN375 mg/1

Pharmacological Class

  • Cyclooxygenase 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 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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.