NDC 45865-581

NAPROXEN

Naproxen

NAPROXEN is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Medsource Pharmaceuticals. The primary component is Naproxen.

Product ID45865-581_7d634e58-bdb2-14b0-e053-2a91aa0a50d9
NDC45865-581
Product TypeHuman Prescription Drug
Proprietary NameNAPROXEN
Generic NameNaproxen
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2016-07-06
Marketing CategoryANDA / ANDA
Application NumberANDA091416
Labeler Namemedsource pharmaceuticals
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 Through2020-12-31

Packaging

NDC 45865-581-30

30 TABLET in 1 BOTTLE, PLASTIC (45865-581-30)
Marketing Start Date2018-06-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 45865-581-90 [45865058190]

NAPROXEN TABLET
Marketing CategoryANDA
Application NumberANDA091416
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-06-01

NDC 45865-581-60 [45865058160]

NAPROXEN TABLET
Marketing CategoryANDA
Application NumberANDA091416
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-06-01

NDC 45865-581-30 [45865058130]

NAPROXEN TABLET
Marketing CategoryANDA
Application NumberANDA091416
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-06-01

Drug Details

Active Ingredients

IngredientStrength
NAPROXEN500 mg/1

OpenFDA Data

SPL SET ID:7d634e58-bdb1-14b0-e053-2a91aa0a50d9
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 198014
    • 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]
    • Anti-Inflammatory Agents
    • Non-Steroidal [CS]
    • Cyclooxygenase Inhibitors [MoA]
    • Anti-Inflammatory Agents
    • Non-Steroidal [CS]
    • Nonsteroidal Anti-inflammatory Drug [EPC]

    NDC Crossover Matching brand name "NAPROXEN" or generic name "Naproxen"

    NDCBrand NameGeneric Name
    0054-3630NaproxenNaproxen
    0093-1005NaproxenNaproxen
    0093-1006NaproxenNaproxen
    0143-1346NaproxenNaproxen
    0143-1347NaproxenNaproxen
    0143-1348NaproxenNaproxen
    0143-9908NAPROXENnaproxen sodium
    0143-9916NAPROXENnaproxen sodium
    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
    10544-614NAPROXENnaproxen sodium
    10544-920NaproxenNaproxen
    10544-922NaproxenNaproxen
    10544-939NaproxenNaproxen
    12634-498NaproxenNaproxen
    68071-3092NaproxenNaproxen
    68071-4006NAPROXENNAPROXEN
    68071-3029naproxennaproxen
    68071-3066naproxennaproxen
    68071-3387NaproxenNaproxen
    68071-3345NAPROXENNAPROXEN
    68071-4510NAPROXENNAPROXEN
    68071-4381NAPROXENNAPROXEN
    68134-201NaproxenNaproxen
    68151-2894NaproxenNaproxen
    68151-2609NaproxenNaproxen
    68151-2895NaproxenNaproxen
    68382-012NaproxenNaproxen
    68382-013NaproxenNaproxen
    68382-014NaproxenNaproxen
    68387-800NaproxenNaproxen
    68387-801NaproxenNaproxen
    68387-802NaproxenNaproxen
    68462-190NaproxenNaproxen
    68462-189NaproxenNaproxen
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