NDC 70748-215

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 Lupin Pharmaceuticals, Inc.. The primary component is Esomeprazole Magnesium; Naproxen.

Product ID70748-215_299bc1f9-3164-4413-8c94-a972b1d98463
NDC70748-215
Product TypeHuman Prescription Drug
Proprietary NameNAPROXEN AND ESOMEPRAZOLE MAGNESIUM
Generic NameNaproxen And Esomeprazole Magnesium
Dosage FormTablet, Delayed Release
Route of AdministrationORAL
Marketing Start Date2020-03-04
Marketing CategoryNDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
Application NumberNDA022511
Labeler NameLupin 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 70748-215-07

60 TABLET, DELAYED RELEASE in 1 BOTTLE (70748-215-07)
Marketing Start Date2020-03-04
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70748-215-07 [70748021507]

NAPROXEN AND ESOMEPRAZOLE MAGNESIUM TABLET, DELAYED RELEASE
Marketing CategoryNDA authorized generic
Application NumberNDA022511
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2020-03-04

Drug Details

Active Ingredients

IngredientStrength
NAPROXEN375 mg/1

OpenFDA Data

SPL SET ID:baf0a8a7-81dc-4b56-b097-c52ca286f41e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 994008
  • 994005
    • UPC Code
  • 0370748215074
  • 0370748216071

    • 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
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