NDC 68387-800

Naproxen

Naproxen

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

Product ID68387-800_e242ccf8-7339-4a43-82ff-a7b0a6384799
NDC68387-800
Product TypeHuman Prescription Drug
Proprietary NameNaproxen
Generic NameNaproxen
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2009-04-27
Marketing CategoryANDA / ANDA
Application NumberANDA075927
Labeler NameKeltman Pharmaceuticals Inc.
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 Through2017-12-31

Packaging

NDC 68387-800-14

14 TABLET in 1 BOTTLE, PLASTIC (68387-800-14)
Marketing Start Date2009-04-27
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68387-800-30 [68387080030]

Naproxen TABLET
Marketing CategoryANDA
Application NumberANDA075927
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-10-29
Inactivation Date2019-10-29

NDC 68387-800-14 [68387080014]

Naproxen TABLET
Marketing CategoryANDA
Application NumberANDA075927
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-04-27
Inactivation Date2019-10-29

NDC 68387-800-60 [68387080060]

Naproxen TABLET
Marketing CategoryANDA
Application NumberANDA075927
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-10-29
Inactivation Date2019-10-29

NDC 68387-800-90 [68387080090]

Naproxen TABLET
Marketing CategoryANDA
Application NumberANDA075927
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-04-27
Inactivation Date2019-10-29

Drug Details

Active Ingredients

IngredientStrength
NAPROXEN500 mg/1

OpenFDA Data

SPL SET ID:1a10952e-0662-4f2c-bd02-28dd4eee138f
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 198013
  • 198012
  • 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]

    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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