NDC 10544-614

NAPROXEN

Naproxen Sodium

NAPROXEN is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Blenheim Pharmacal, Inc.. The primary component is Naproxen Sodium.

Product ID10544-614_11b938f8-f1df-4d63-e054-00144ff88e88
NDC10544-614
Product TypeHuman Prescription Drug
Proprietary NameNAPROXEN
Generic NameNaproxen Sodium
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2010-05-17
Marketing CategoryANDA / ANDA
Application NumberANDA074480
Labeler NameBlenheim Pharmacal, Inc.
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 10544-614-20

20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (10544-614-20)
Marketing Start Date2010-05-18
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 10544-614-20 [10544061420]

NAPROXEN TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA074480
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-05-18
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
NAPROXEN SODIUM550 mg/1

OpenFDA Data

SPL SET ID:11b938f8-f1de-4d63-e054-00144ff88e88
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 849431
  • UPC Code
  • 0310544614206
  • Pharmacological Class

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

    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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