NDC 68788-7304

Naproxen Sodium

Naproxen Sodium

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

Product ID68788-7304_750cd01d-859a-410b-9e4d-ee9b2ba60bc1
NDC68788-7304
Product TypeHuman Prescription Drug
Proprietary NameNaproxen Sodium
Generic NameNaproxen Sodium
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2019-01-03
Marketing CategoryANDA / ANDA
Application NumberANDA200629
Labeler NamePreferred Pharmaceuticals Inc.
Substance NameNAPROXEN SODIUM
Active Ingredient Strength550 mg/1
Pharm ClassesCyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 68788-7304-1

100 TABLET, FILM COATED in 1 BOTTLE (68788-7304-1)
Marketing Start Date2019-01-03
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68788-7304-4 [68788730404]

Naproxen Sodium TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA200629
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-01-03

NDC 68788-7304-3 [68788730403]

Naproxen Sodium TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA200629
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-01-03

NDC 68788-7304-9 [68788730409]

Naproxen Sodium TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA200629
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-01-03

NDC 68788-7304-1 [68788730401]

Naproxen Sodium TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA200629
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-01-03

NDC 68788-7304-6 [68788730406]

Naproxen Sodium TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA200629
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-01-03

NDC 68788-7304-8 [68788730408]

Naproxen Sodium TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA200629
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-01-03

NDC 68788-7304-2 [68788730402]

Naproxen Sodium TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA200629
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-01-03

Drug Details

Active Ingredients

IngredientStrength
NAPROXEN SODIUM550 mg/1

OpenFDA Data

SPL SET ID:cf542cfe-85c6-4cba-bbf6-41e80ee43c23
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 849431

    • Pharmacological Class

    • Cyclooxygenase Inhibitors [MoA]
    • Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient]
    • Nonsteroidal Anti-inflammatory Drug [EPC]
    • Anti-Inflammatory Agents
    • Non-Steroidal [CS]
    • Cyclooxygenase Inhibitors [MoA]
    • Anti-Inflammatory Agents
    • Non-Steroidal [CS]
    • Nonsteroidal Anti-inflammatory Drug [EPC]

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

    NDCBrand NameGeneric Name
    68016-056Naproxen SodiumNaproxen Sodium
    68016-661Naproxen SodiumNaproxen Sodium
    68016-660Naproxen SodiumNaproxen Sodium
    68071-3054Naproxen SodiumNaproxen Sodium
    68071-3223Naproxen SodiumNaproxen Sodium
    68210-0040NAPROXEN SODIUMNAPROXEN SODIUM
    68210-0400NAPROXEN SODIUMNAPROXEN SODIUM
    68387-545Naproxen SodiumNaproxen Sodium
    68462-179Naproxen SodiumNaproxen Sodium
    68462-178Naproxen SodiumNaproxen Sodium
    68788-6406Naproxen SodiumNaproxen Sodium
    68788-7304Naproxen SodiumNaproxen Sodium
    68788-6934Naproxen SodiumNaproxen Sodium
    68788-7367Naproxen SodiumNaproxen Sodium
    68788-9022Naproxen SodiumNaproxen Sodium
    68998-144NAPROXEN SODIUMNAPROXEN SODIUM
    68998-145NAPROXEN SODIUMNAPROXEN SODIUM
    69168-632Naproxen SodiumNaproxen Sodium
    69230-305Naproxen SodiumNaproxen Sodium
    69452-179Naproxen SodiumNaproxen Sodium
    69469-169Naproxen SodiumNaproxen Sodium
    69842-010naproxen sodiumnaproxen sodium
    69842-748Naproxen SodiumNaproxen Sodium
    69842-417Naproxen SodiumNaproxen Sodium
    69842-975Naproxen SodiumNaproxen Sodium
    69842-811Naproxen SodiumNaproxen Sodium
    70518-0409Naproxen SodiumNaproxen Sodium
    70518-0178Naproxen sodiumNaproxen sodium
    70518-0724Naproxen SodiumNaproxen Sodium
    70518-1172Naproxen SodiumNaproxen Sodium
    71141-116NAPROXEN SODIUMNAPROXEN SODIUM
    71141-008Naproxen SodiumNaproxen Sodium
    71335-0274Naproxen SodiumNaproxen Sodium
    71335-0822Naproxen SodiumNaproxen Sodium
    71335-1061Naproxen SodiumNaproxen Sodium
    10544-275Naproxen SodiumNaproxen Sodium
    10544-128Naproxen SodiumNaproxen Sodium
    10544-063Naproxen SodiumNaproxen Sodium
    10544-276Naproxen SodiumNaproxen Sodium
    11673-175Naproxen SodiumNaproxen Sodium
    11822-0507naproxen sodiumnaproxen sodium
    11673-748Naproxen SodiumNaproxen Sodium
    11822-0490naproxen sodiumnaproxen sodium
    11822-0140Naproxen SodiumNaproxen Sodium
    21130-174Naproxen SodiumNaproxen Sodium
    21130-748Naproxen SodiumNaproxen Sodium
    21695-090Naproxen SodiumNaproxen Sodium
    17856-0194Naproxen SodiumNaproxen Sodium
    25000-141Naproxen SodiumNaproxen Sodium
    25000-144Naproxen SodiumNaproxen Sodium
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