NDC 51655-628

Naproxen Delayed Release

Naproxen Delayed Release

Naproxen Delayed Release is a Oral Tablet, Delayed Release in the Human Prescription Drug category. It is labeled and distributed by Northwind Pharmaceuticals. The primary component is Naproxen.

Product ID51655-628_bf547f77-f9d8-475d-8bf5-4ec40b616b0f
NDC51655-628
Product TypeHuman Prescription Drug
Proprietary NameNaproxen Delayed Release
Generic NameNaproxen Delayed Release
Dosage FormTablet, Delayed Release
Route of AdministrationORAL
Marketing Start Date2014-05-16
Marketing CategoryANDA / ANDA
Application NumberANDA091432
Labeler NameNorthwind Pharmaceuticals
Substance NameNAPROXEN
Active Ingredient Strength500 mg/1
Pharm ClassesCyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 51655-628-52

30 TABLET, DELAYED RELEASE in 1 BOTTLE, DISPENSING (51655-628-52)
Marketing Start Date2014-05-16
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 51655-628-52 [51655062852]

Naproxen Delayed Release TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA091432
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-05-16
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
NAPROXEN500 mg/1

OpenFDA Data

SPL SET ID:c66b0b05-84b4-4f0c-82b2-f0c386f6f64f
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 311915
  • PHarm Class EPC
  • Nonsteroidal Anti-inflammatory Drug [EPC]
  • NUI Code
  • N0000000160
  • N0000175722
  • N0000175721
  • Pharmacological Class

    • Cyclooxygenase Inhibitors [MoA]
    • Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient]
    • Nonsteroidal Anti-inflammatory Drug [EPC]

    NDC Crossover Matching brand name "Naproxen Delayed Release" or generic name "Naproxen Delayed Release"

    NDCBrand NameGeneric Name
    51655-628Naproxen Delayed ReleaseNaproxen Delayed Release
    68788-6322Naproxen delayed releaseNaproxen delayed release
    10544-920Naproxen delayed releaseNaproxen delayed release
    31722-339Naproxen delayed releaseNaproxen delayed release
    31722-338Naproxen delayed releaseNaproxen delayed release
    42291-630Naproxen delayed releaseNaproxen delayed release
    42291-629Naproxen delayed releaseNaproxen delayed release

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