NDC 61919-183

ANAPROX

Naproxen Sodium

ANAPROX is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Direct Rx. The primary component is Naproxen Sodium.

Product ID61919-183_3784e189-f432-54d2-e054-00144ff8d46c
NDC61919-183
Product TypeHuman Prescription Drug
Proprietary NameANAPROX
Generic NameNaproxen Sodium
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2016-07-11
Marketing CategoryANDA / ANDA
Application NumberANDA078314
Labeler NameDIRECT RX
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 Through2017-12-31

Packaging

NDC 61919-183-60

60 TABLET in 1 BOTTLE (61919-183-60)
Marketing Start Date2016-07-11
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 61919-183-60 [61919018360]

ANAPROX TABLET
Marketing CategoryANDA
Application NumberANDA078314
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-07-11

Drug Details

Active Ingredients

IngredientStrength
NAPROXEN SODIUM550 mg/1

OpenFDA Data

SPL SET ID:3784e189-f431-54d2-e054-00144ff8d46c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 849438
  • 849431

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    61919-183ANAPROXANAPROX
    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 [ANAPROX]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ANAPROX
    ANAPROX
    73006255 0996040 Live/Registered
    SYNTEX (U.S.A.) INC.
    1973-11-13
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