NDC 52427-272

Naprelan

Naproxen Sodium

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

Product ID52427-272_17148bdd-3818-b718-fa09-07fd74b76d40
NDC52427-272
Product TypeHuman Prescription Drug
Proprietary NameNaprelan
Generic NameNaproxen Sodium
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2014-01-17
Marketing CategoryNDA / NDA
Application NumberNDA020353
Labeler NameALMATICA PHARMA INC.
Substance NameNAPROXEN SODIUM
Active Ingredient Strength375 mg/1
Pharm ClassesAnti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 52427-272-01

100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (52427-272-01)
Marketing Start Date2014-01-17
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 52427-272-01 [52427027201]

Naprelan TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA020353
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-01-17

Drug Details

Active Ingredients

IngredientStrength
NAPROXEN SODIUM375 mg/1

OpenFDA Data

SPL SET ID:e633ff0b-eab7-f167-8d08-e9236e54042b
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1116349
  • 1116341
  • 1116331
  • 1116320
  • 1116351
  • 1116339
    • UPC Code
  • 0352427273759
  • 0352427274305
  • 0352427272011

    • Pharmacological Class

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

    Medicade Reported Pricing

    52427027201 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
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.