NDC 42291-629

Naproxen delayed release

Naproxen

Naproxen delayed release is a Oral Tablet, Delayed Release in the Human Prescription Drug category. It is labeled and distributed by Avkare, Inc.. The primary component is Naproxen.

Product ID42291-629_63f042c4-da39-2310-e053-2991aa0ac7d4
NDC42291-629
Product TypeHuman Prescription Drug
Proprietary NameNaproxen delayed release
Generic NameNaproxen
Dosage FormTablet, Delayed Release
Route of AdministrationORAL
Marketing Start Date2013-10-24
Marketing CategoryANDA / ANDA
Application NumberANDA091432
Labeler NameAvKARE, Inc.
Substance NameNAPROXEN
Active Ingredient Strength375 mg/1
Pharm ClassesCyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 42291-629-01

100 TABLET, DELAYED RELEASE in 1 BOTTLE (42291-629-01)
Marketing Start Date2013-10-24
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 42291-629-01 [42291062901]

Naproxen delayed release TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA091432
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-10-24

Drug Details

Active Ingredients

IngredientStrength
NAPROXEN375 mg/1

OpenFDA Data

SPL SET ID:d17048e2-02a9-d33f-f129-154e36213fdd
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 603103
  • 311915
    • PHarm Class EPC
  • Nonsteroidal Anti-inflammatory Drug [EPC]
    • UPC Code
  • 0342291629011
    • NUI Code
  • N0000000160
  • N0000175722
  • N0000175721

    • Pharmacological Class

    • Cyclooxygenase Inhibitors [MoA]
    • Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient]
    • Nonsteroidal Anti-inflammatory Drug [EPC]
    • Anti-Inflammatory Agents
    • Non-Steroidal [CS]

    NDC Crossover Matching brand name "Naproxen delayed release" or generic name "Naproxen"

    NDCBrand NameGeneric Name
    68788-6322Naproxen 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
    51655-628Naproxen Delayed ReleaseNaproxen Delayed Release
    0363-9609BACK AND MUSCLE PAINNAPROXEN
    0004-6415EC-Naprosynnaproxen
    0121-0899NaprosynNaproxen
    0121-1798NaprosynNaproxen
    0121-2697NaprosynNaproxen
    0054-3630NaproxenNaproxen
    0093-1005NaproxenNaproxen
    0093-1006NaproxenNaproxen
    0143-1346NaproxenNaproxen
    0143-1347NaproxenNaproxen
    0143-1348NaproxenNaproxen
    0179-1978NaproxenNaproxen
    0440-1852NaproxenNaproxen
    0440-7852NaproxenNaproxen
    0615-1504NaproxenNaproxen
    0615-3562NaproxenNaproxen
    0615-3563NaproxenNaproxen
    0615-7709NaproxenNaproxen
    0615-7892NaproxenNaproxen
    0615-8094NaproxenNaproxen
    10544-010NaproxenNaproxen
    10544-016NaproxenNaproxen
    10544-019NaproxenNaproxen
    10544-044NaproxenNaproxen
    10544-061NaproxenNaproxen
    10544-111NAPROXENNAPROXEN
    10544-277NaproxenNaproxen
    10544-278NaproxenNaproxen
    10544-920NaproxenNaproxen
    10544-922NaproxenNaproxen
    10544-939NaproxenNaproxen
    12634-498NaproxenNaproxen
    12634-684NaproxenNaproxen
    21695-084NaproxenNaproxen
    21695-085NaproxenNaproxen
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.