NDC 59630-375

Naprelan

Naproxen Sodium

Naprelan is a Oral Tablet, Film Coated, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Shionogi Inc.. The primary component is Naproxen Sodium.

Product ID59630-375_00ea44c7-97e5-426f-b0f2-8884e8bfa7dc
NDC59630-375
Product TypeHuman Prescription Drug
Proprietary NameNaprelan
Generic NameNaproxen Sodium
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date1996-04-01
Marketing CategoryNDA / NDA
Application NumberNDA020353
Labeler NameShionogi Inc.
Substance NameNAPROXEN SODIUM
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 59630-375-10

100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (59630-375-10)
Marketing Start Date1996-04-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 59630-375-10 [59630037510]

Naprelan TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA020353
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1996-04-01
Inactivation Date2019-11-27

Drug Details

Active Ingredients

IngredientStrength
NAPROXEN SODIUM375 mg/1

OpenFDA Data

SPL SET ID:15ab6690-53bf-4669-950f-35db4dba8fac
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1116349
  • 1116341
  • 1116331
  • 1116320
  • 1116351
  • 1116339
    • UPC Code
  • 1978113777036

    • Pharmacological Class

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

    Medicade Reported Pricing

    59630037510 NAPRELAN CR 375 MG TABLET

    Pricing Unit: EA | Drug Type:

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

    NDCBrand NameGeneric Name
    21695-905NAPRELANNAPRELAN
    21695-906NAPRELANNAPRELAN
    52427-273NaprelanNaprelan
    52427-274NaprelanNaprelan
    52427-272NaprelanNaprelan
    59630-375NaprelanNaprelan
    59630-850NaprelanNaprelan
    59630-777NaprelanNaprelan
    0280-6000AleveNAPROXEN SODIUM
    0280-6010AleveNAPROXEN SODIUM
    0280-6020AleveNAPROXEN SODIUM
    0280-0041Aleve Headache PainNaproxen Sodium
    0113-7033basic care naproxen sodiumNaproxen Sodium
    0113-7368Basic Care Naproxen SodiumNaproxen Sodium
    0113-7901basic care naproxen sodiumNaproxen Sodium
    0113-0901Good Sense Naproxen SodiumNaproxen Sodium
    0113-1412good sense naproxen sodiumnaproxen sodium
    0113-1773good sense naproxen sodiumNaproxen Sodium
    0113-4368Good Sense Naproxen SodiumNaproxen Sodium
    0280-0270MenstridolNAPROXEN SODIUM
    0143-9908NAPROXENnaproxen sodium
    0143-9916NAPROXENnaproxen sodium

    Trademark Results [Naprelan]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    NAPRELAN
    NAPRELAN
    73659443 1955461 Live/Registered
    ELAN CORPORATION, PLC.
    1987-05-07
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