NDC 46122-564

Naproxen

Naproxen Sodium

Naproxen is a Oral Tablet, Film Coated in the Human Otc Drug category. It is labeled and distributed by Amerisource Bergen. The primary component is Naproxen Sodium.

Product ID46122-564_1ad6b107-492a-4031-98a1-ac2469fd0e66
NDC46122-564
Product TypeHuman Otc Drug
Proprietary NameNaproxen
Generic NameNaproxen Sodium
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2019-02-01
Marketing CategoryANDA / ANDA
Application NumberANDA204872
Labeler NameAmerisource Bergen
Substance NameNAPROXEN SODIUM
Active Ingredient Strength220 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 46122-564-71

1 BOTTLE, PLASTIC in 1 CARTON (46122-564-71) > 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Marketing Start Date2019-02-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 46122-564-71 [46122056471]

Naproxen TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA204872
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2019-02-01

NDC 46122-564-81 [46122056481]

Naproxen TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA204872
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2019-02-01

NDC 46122-564-78 [46122056478]

Naproxen TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA204872
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2019-02-01

Drug Details

Active Ingredients

IngredientStrength
NAPROXEN SODIUM220 mg/1

OpenFDA Data

SPL SET ID:1e2e6e3a-b095-4d5b-86fe-61eb44a87cf0
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 849574
    • UPC Code
  • 0087701431623

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

    NDCBrand NameGeneric Name
    0054-3630NaproxenNaproxen
    0093-1005NaproxenNaproxen
    0093-1006NaproxenNaproxen
    0143-1346NaproxenNaproxen
    0143-1347NaproxenNaproxen
    0143-1348NaproxenNaproxen
    0143-9908NAPROXENnaproxen sodium
    0143-9916NAPROXENnaproxen sodium
    0179-1978NaproxenNaproxen
    68071-3092NaproxenNaproxen
    68071-4006NAPROXENNAPROXEN
    68071-3029naproxennaproxen
    68071-3066naproxennaproxen
    68071-3387NaproxenNaproxen
    68071-3345NAPROXENNAPROXEN
    68071-4510NAPROXENNAPROXEN
    68071-4381NAPROXENNAPROXEN
    0440-1852NaproxenNaproxen
    68134-201NaproxenNaproxen
    0440-7852NaproxenNaproxen
    68151-2894NaproxenNaproxen
    68151-2609NaproxenNaproxen
    68151-2895NaproxenNaproxen
    68382-012NaproxenNaproxen
    68382-013NaproxenNaproxen
    68382-014NaproxenNaproxen
    68387-800NaproxenNaproxen
    68387-801NaproxenNaproxen
    68387-802NaproxenNaproxen
    68462-190NaproxenNaproxen
    68462-189NaproxenNaproxen
    68462-188NaproxenNaproxen
    68788-6421NaproxenNaproxen
    68788-6908NaproxenNaproxen
    68788-6998NAPROXENNAPROXEN
    68788-7072NaproxenNaproxen
    68788-9151NaproxenNaproxen
    68788-7090NaproxenNaproxen
    68788-6842NaproxenNaproxen
    68788-9906NaproxenNaproxen
    68788-9878NaproxenNaproxen
    68788-9907NaproxenNaproxen
    69097-852NaproxenNaproxen
    69150-139NAPROXENNAPROXEN
    69150-140NAPROXENNAPROXEN
    69097-855naproxennaproxen
    69097-854naproxennaproxen
    69150-138NAPROXENNAPROXEN
    69097-851NaproxenNaproxen
    69097-853naproxennaproxen
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