NDC 69784-500

EC-NAPROXEN

Naproxen

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

Product ID69784-500_3cf69408-c2d6-453f-ab49-3007f220dd70
NDC69784-500
Product TypeHuman Prescription Drug
Proprietary NameEC-NAPROXEN
Generic NameNaproxen
Dosage FormTablet, Delayed Release
Route of AdministrationORAL
Marketing Start Date2018-10-15
Marketing CategoryNDA / NDA
Application NumberNDA020067
Labeler NameWoodward Pharma Services LLC
Substance NameNAPROXEN
Active Ingredient Strength500 mg/1
Pharm ClassesCyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 69784-500-01

100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (69784-500-01)
Marketing Start Date2018-10-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69784-500-01 [69784050001]

EC-NAPROXEN TABLET, DELAYED RELEASE
Marketing CategoryNDA
Application NumberNDA020067
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-10-15

Drug Details

Active Ingredients

IngredientStrength
NAPROXEN500 mg/1

OpenFDA Data

SPL SET ID:0728935b-19fc-4a10-aeba-29c42ce7f472
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 849431
  • 603103
  • 311915
  • 198014
  • PHarm Class EPC
  • Nonsteroidal Anti-inflammatory Drug [EPC]
  • UPC Code
  • 0369784505010
  • 0369784501012
  • 0369784500015
  • 0369784550010
  • 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]

    Medicade Reported Pricing

    69784050001 EC-NAPROXEN DR 500 MG TABLET

    Pricing Unit: EA | Drug Type:

    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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