NDC 71511-701

Naprosyn

Naproxen

Naprosyn is a Oral Suspension in the Human Prescription Drug category. It is labeled and distributed by Athena Bioscience. The primary component is Naproxen.

Product ID71511-701_2513454d-a89e-4bb4-ba9e-c344046bbafe
NDC71511-701
Product TypeHuman Prescription Drug
Proprietary NameNaprosyn
Generic NameNaproxen
Dosage FormSuspension
Route of AdministrationORAL
Marketing Start Date2018-01-01
Marketing CategoryNDA / NDA
Application NumberNDA018965
Labeler NameAthena Bioscience
Substance NameNAPROXEN
Active Ingredient Strength125 mg/5mL
Pharm ClassesCyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 71511-701-16

473 mL in 1 BOTTLE, PLASTIC (71511-701-16)
Marketing Start Date2018-01-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71511-701-16 [71511070116]

Naprosyn SUSPENSION
Marketing CategoryNDA
Application NumberNDA018965
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2018-01-01

Drug Details

Active Ingredients

IngredientStrength
NAPROXEN125 mg/5mL

OpenFDA Data

SPL SET ID:f9b4173d-7836-4d7d-b149-1d96f9377ad0
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 311913
  • 207093
    • 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 "Naprosyn" or generic name "Naproxen"

    NDCBrand NameGeneric Name
    0121-0899NaprosynNaproxen
    0121-1798NaprosynNaproxen
    0121-2697NaprosynNaproxen
    69437-316NaprosynNaprosyn
    71511-701NaprosynNaprosyn
    80425-0048NaprosynNaprosyn
    80425-0051NaprosynNaprosyn
    80425-0050NaprosynNaprosyn
    80425-0049NaprosynNaprosyn
    80425-0010NaprosynNaprosyn
    0363-9609BACK AND MUSCLE PAINNAPROXEN
    0004-6415EC-Naprosynnaproxen
    0054-3630NaproxenNaproxen
    0093-1005NaproxenNaproxen
    0093-1006NaproxenNaproxen
    0143-1346NaproxenNaproxen
    0143-1347NaproxenNaproxen
    0143-1348NaproxenNaproxen
    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
    10544-920NaproxenNaproxen
    10544-922NaproxenNaproxen
    10544-939NaproxenNaproxen
    12634-498NaproxenNaproxen
    12634-684NaproxenNaproxen
    21695-084NaproxenNaproxen
    21695-085NaproxenNaproxen

    Trademark Results [Naprosyn]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    NAPROSYN
    NAPROSYN
    72406172 0951192 Live/Registered
    SYNTEX LABORATORIES, INC.
    1971-10-27
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