NDC 42494-407

EC-NAPROXEN

Naproxen

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

Product ID42494-407_64efd778-d06c-4289-95f6-ae1fbd6efd35
NDC42494-407
Product TypeHuman Prescription Drug
Proprietary NameEC-NAPROXEN
Generic NameNaproxen
Dosage FormTablet, Delayed Release
Route of AdministrationORAL
Marketing Start Date2016-07-10
Marketing CategoryNDA / NDA
Application NumberNDA020067
Labeler NameCameron Pharmaceuticals, LLC
Substance NameNAPROXEN
Active Ingredient Strength375 mg/1
Pharm ClassesCyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 42494-407-01

100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (42494-407-01)
Marketing Start Date2016-07-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 42494-407-01 [42494040701]

EC-NAPROXEN TABLET, DELAYED RELEASE
Marketing CategoryNDA
Application NumberNDA020067
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-07-10
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
NAPROXEN375 mg/1

OpenFDA Data

SPL SET ID:b86b31e9-1726-414a-877e-50079c017339
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 849398
  • 849431
  • 603103
  • 198013
  • 198012
  • 311915
  • 198014
  • PHarm Class EPC
  • Nonsteroidal Anti-inflammatory Drug [EPC]
  • UPC Code
  • 0342494404057
  • 0342494405016
  • 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 "EC-NAPROXEN" or generic name "Naproxen"

    NDCBrand NameGeneric Name
    69784-500EC-NAPROXENEC-NAPROXEN
    69784-501EC-NAPROXENEC-NAPROXEN
    42494-407EC-NAPROXENEC-NAPROXEN
    42494-408EC-NAPROXENEC-NAPROXEN
    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

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