NDC 21695-905

NAPRELAN

Naproxen Sodium

NAPRELAN is a Oral Tablet, Film Coated, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Rebel Distributors Corp. The primary component is Naproxen Sodium.

Product ID21695-905_1f949140-68b5-4602-936f-1936e436d553
NDC21695-905
Product TypeHuman Prescription Drug
Proprietary NameNAPRELAN
Generic NameNaproxen Sodium
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date1996-01-05
Marketing CategoryNDA / NDA
Application NumberNDA020353
Labeler NameRebel Distributors Corp
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 21695-905-60

60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (21695-905-60)
Marketing Start Date1996-01-05
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 21695-905-60 [21695090560]

NAPRELAN TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA020353
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1996-01-05
Inactivation Date2019-09-24

Drug Details

Active Ingredients

IngredientStrength
NAPROXEN SODIUM375 mg/1

OpenFDA Data

SPL SET ID:1f949140-68b5-4602-936f-1936e436d553
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1116341
  • 1116331
  • 1116320
  • 1116339

    • Pharmacological Class

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

    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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