NDC 33261-085

Naproxen Sodium

Naproxen Sodium

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

Product ID33261-085_f67ff8f9-fff1-4cd4-abc6-819b577837dc
NDC33261-085
Product TypeHuman Prescription Drug
Proprietary NameNaproxen Sodium
Generic NameNaproxen Sodium
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2007-04-26
Marketing CategoryANDA / ANDA
Application NumberANDA078432
Labeler NameAidarex Pharmaceuticals LLC
Substance NameNAPROXEN SODIUM
Active Ingredient Strength550 mg/1
Pharm ClassesCyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 33261-085-84

84 TABLET in 1 BOTTLE, PLASTIC (33261-085-84)
Marketing Start Date2007-04-26
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 33261-085-14 [33261008514]

NAPROXEN SODIUM TABLET
Marketing CategoryANDA
Application NumberANDA078432
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2007-04-26
Inactivation Date2020-01-31

NDC 33261-085-00 [33261008500]

NAPROXEN SODIUM TABLET
Marketing CategoryANDA
Application NumberANDA078432
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2007-04-26
Inactivation Date2020-01-31

NDC 33261-085-02 [33261008502]

NAPROXEN SODIUM TABLET
Marketing CategoryANDA
Application NumberANDA078432
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2007-04-26
Inactivation Date2020-01-31

NDC 33261-085-30 [33261008530]

NAPROXEN SODIUM TABLET
Marketing CategoryANDA
Application NumberANDA078432
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2007-04-26
Inactivation Date2020-01-31

NDC 33261-085-90 [33261008590]

NAPROXEN SODIUM TABLET
Marketing CategoryANDA
Application NumberANDA078432
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2007-04-26
Inactivation Date2020-01-31

NDC 33261-085-60 [33261008560]

NAPROXEN SODIUM TABLET
Marketing CategoryANDA
Application NumberANDA078432
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2007-04-26
Inactivation Date2020-01-31

NDC 33261-085-20 [33261008520]

NAPROXEN SODIUM TABLET
Marketing CategoryANDA
Application NumberANDA078432
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2007-04-26
Inactivation Date2020-01-31

NDC 33261-085-21 [33261008521]

NAPROXEN SODIUM TABLET
Marketing CategoryANDA
Application NumberANDA078432
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2007-04-26
Inactivation Date2020-01-31

NDC 33261-085-84 [33261008584]

NAPROXEN SODIUM TABLET
Marketing CategoryANDA
Application NumberANDA078432
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2007-04-26
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
NAPROXEN SODIUM550 mg/1

OpenFDA Data

SPL SET ID:30cc16cd-720d-4baa-8941-bfdc28b62b04
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 849398
  • 849431
  • Pharmacological Class

    • Cyclooxygenase Inhibitors [MoA]
    • Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient]
    • Nonsteroidal Anti-inflammatory Drug [EPC]

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

    NDCBrand NameGeneric Name
    68016-056Naproxen SodiumNaproxen Sodium
    68016-661Naproxen SodiumNaproxen Sodium
    68016-660Naproxen SodiumNaproxen Sodium
    68071-3054Naproxen SodiumNaproxen Sodium
    68071-3223Naproxen SodiumNaproxen Sodium
    68210-0040NAPROXEN SODIUMNAPROXEN SODIUM
    68210-0400NAPROXEN SODIUMNAPROXEN SODIUM
    68387-545Naproxen SodiumNaproxen Sodium
    68462-179Naproxen SodiumNaproxen Sodium
    68462-178Naproxen SodiumNaproxen Sodium
    68788-6406Naproxen SodiumNaproxen Sodium
    68788-7304Naproxen SodiumNaproxen Sodium
    68788-6934Naproxen SodiumNaproxen Sodium
    68788-7367Naproxen SodiumNaproxen Sodium
    68788-9022Naproxen SodiumNaproxen Sodium
    68998-144NAPROXEN SODIUMNAPROXEN SODIUM
    68998-145NAPROXEN SODIUMNAPROXEN SODIUM
    69168-632Naproxen SodiumNaproxen Sodium
    69230-305Naproxen SodiumNaproxen Sodium
    69452-179Naproxen SodiumNaproxen Sodium
    69469-169Naproxen SodiumNaproxen Sodium
    69842-010naproxen sodiumnaproxen sodium
    69842-748Naproxen SodiumNaproxen Sodium
    69842-417Naproxen SodiumNaproxen Sodium
    69842-975Naproxen SodiumNaproxen Sodium
    69842-811Naproxen SodiumNaproxen Sodium
    70518-0409Naproxen SodiumNaproxen Sodium
    70518-0178Naproxen sodiumNaproxen sodium
    70518-0724Naproxen SodiumNaproxen Sodium
    70518-1172Naproxen SodiumNaproxen Sodium
    71141-116NAPROXEN SODIUMNAPROXEN SODIUM
    71141-008Naproxen SodiumNaproxen Sodium
    71335-0274Naproxen SodiumNaproxen Sodium
    71335-0822Naproxen SodiumNaproxen Sodium
    71335-1061Naproxen SodiumNaproxen Sodium
    10544-275Naproxen SodiumNaproxen Sodium
    10544-128Naproxen SodiumNaproxen Sodium
    10544-063Naproxen SodiumNaproxen Sodium
    10544-276Naproxen SodiumNaproxen Sodium
    11673-175Naproxen SodiumNaproxen Sodium
    11822-0507naproxen sodiumnaproxen sodium
    11673-748Naproxen SodiumNaproxen Sodium
    11822-0490naproxen sodiumnaproxen sodium
    11822-0140Naproxen SodiumNaproxen Sodium
    21130-174Naproxen SodiumNaproxen Sodium
    21130-748Naproxen SodiumNaproxen Sodium
    21695-090Naproxen SodiumNaproxen Sodium
    17856-0194Naproxen SodiumNaproxen Sodium
    25000-141Naproxen SodiumNaproxen Sodium
    25000-144Naproxen SodiumNaproxen Sodium

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.