NDC 53746-191

Naproxen Sodium (NSAID) Fever Reducer/ Pain Reliever

Naproxen Sodium

Naproxen Sodium (NSAID) Fever Reducer/ Pain Reliever is a Oral Tablet in the Human Otc Drug category. It is labeled and distributed by Amneal Pharmaceuticals Of New York Llc. The primary component is Naproxen Sodium.

Product ID53746-191_01094d21-f8a5-487f-8d39-f32255f9bc9d
NDC53746-191
Product TypeHuman Otc Drug
Proprietary NameNaproxen Sodium (NSAID) Fever Reducer/ Pain Reliever
Generic NameNaproxen Sodium
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2009-11-25
Marketing CategoryANDA / ANDA
Application NumberANDA079096
Labeler NameAmneal Pharmaceuticals of New York LLC
Substance NameNAPROXEN SODIUM
Active Ingredient Strength220 mg/1
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 53746-191-05

500 TABLET in 1 BOTTLE (53746-191-05)
Marketing Start Date2009-11-25
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53746-191-08 [53746019108]

Naproxen Sodium (NSAID) Fever Reducer/ Pain Reliever TABLET
Marketing CategoryANDA
Application NumberANDA079096
Product TypeHUMAN OTC DRUG
Marketing Start Date2009-11-25

NDC 53746-191-24 [53746019124]

Naproxen Sodium (NSAID) Fever Reducer/ Pain Reliever TABLET
Marketing CategoryANDA
Application NumberANDA079096
Product TypeHUMAN OTC DRUG
Marketing Start Date2009-11-25

NDC 53746-191-05 [53746019105]

Naproxen Sodium (NSAID) Fever Reducer/ Pain Reliever TABLET
Marketing CategoryANDA
Application NumberANDA079096
Product TypeHUMAN OTC DRUG
Marketing Start Date2009-11-25

Drug Details

Active Ingredients

IngredientStrength
NAPROXEN SODIUM220 mg/1

OpenFDA Data

SPL SET ID:0bb41b8c-6031-4e96-95e1-31adab811837
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 849574
  • NDC Crossover Matching brand name "Naproxen Sodium (NSAID) Fever Reducer/ Pain Reliever" or generic name "Naproxen Sodium"

    NDCBrand NameGeneric Name
    53746-191Naproxen Sodium (NSAID) Fever Reducer/ Pain RelieverNaproxen Sodium (NSAID) Fever Reducer/ Pain Reliever
    53746-192Naproxen Sodium (NSAID) Fever Reducer/ Pain RelieverNaproxen Sodium (NSAID) Fever Reducer/ Pain Reliever
    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

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