NDC 52959-516

Naproxen

Naproxen

Naproxen is a Oral Tablet, Delayed Release in the Human Prescription Drug category. It is labeled and distributed by H.j. Harkins Company, Inc.. The primary component is Naproxen.

Product ID52959-516_8aaccad1-9c53-4d0d-a05f-b1a1f7c77d1f
NDC52959-516
Product TypeHuman Prescription Drug
Proprietary NameNaproxen
Generic NameNaproxen
Dosage FormTablet, Delayed Release
Route of AdministrationORAL
Marketing Start Date2010-09-23
Marketing CategoryANDA / ANDA
Application NumberANDA075227
Labeler NameH.J. Harkins Company, Inc.
Substance NameNAPROXEN
Active Ingredient Strength500 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 52959-516-10

10 TABLET, DELAYED RELEASE in 1 BOTTLE (52959-516-10)
Marketing Start Date2010-09-23
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 52959-516-20 [52959051620]

Naproxen TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA075227
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-09-23
Inactivation Date2019-11-13

NDC 52959-516-40 [52959051640]

Naproxen TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA075227
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-09-23
Inactivation Date2019-11-13

NDC 52959-516-10 [52959051610]

Naproxen TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA075227
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-09-23
Inactivation Date2019-11-13

NDC 52959-516-14 [52959051614]

Naproxen TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA075227
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-09-23
Inactivation Date2019-11-13

NDC 52959-516-15 [52959051615]

Naproxen TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA075227
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-09-23
Inactivation Date2019-11-13

NDC 52959-516-02 [52959051602]

Naproxen TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA075227
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-09-23
Inactivation Date2019-11-13

NDC 52959-516-60 [52959051660]

Naproxen TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA075227
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-09-23
Inactivation Date2019-11-13

NDC 52959-516-42 [52959051642]

Naproxen TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA075227
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-09-23
Inactivation Date2019-11-13

NDC 52959-516-30 [52959051630]

Naproxen TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA075227
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-09-23
Inactivation Date2019-11-13

Drug Details

Active Ingredients

IngredientStrength
NAPROXEN500 mg/1

OpenFDA Data

SPL SET ID:cce0199c-40e9-4c8c-b04c-c2b969e9a5ba
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 311915
    • PHarm Class EPC
  • Nonsteroidal Anti-inflammatory Drug [EPC]
    • NUI Code
  • N0000000160
  • N0000175722
  • N0000175721

    • 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"

    NDCBrand NameGeneric Name
    0054-3630NaproxenNaproxen
    0093-1005NaproxenNaproxen
    0093-1006NaproxenNaproxen
    0143-1346NaproxenNaproxen
    0143-1347NaproxenNaproxen
    0143-1348NaproxenNaproxen
    0143-9908NAPROXENnaproxen sodium
    0143-9916NAPROXENnaproxen sodium
    0179-1978NaproxenNaproxen
    0440-1852NaproxenNaproxen
    0440-7852NaproxenNaproxen
    0615-1504NaproxenNaproxen
    0615-3562NaproxenNaproxen
    0615-3563NaproxenNaproxen
    0615-7709NaproxenNaproxen
    0615-7892NaproxenNaproxen
    0615-8094NaproxenNaproxen
    10544-010NaproxenNaproxen
    10544-016NaproxenNaproxen
    10544-019NaproxenNaproxen
    10544-044NaproxenNaproxen
    10544-061NaproxenNaproxen
    10544-111NAPROXENNAPROXEN
    10544-277NaproxenNaproxen
    10544-278NaproxenNaproxen
    10544-614NAPROXENnaproxen sodium
    10544-920NaproxenNaproxen
    10544-922NaproxenNaproxen
    10544-939NaproxenNaproxen
    12634-498NaproxenNaproxen
    68071-3092NaproxenNaproxen
    68071-4006NAPROXENNAPROXEN
    68071-3029naproxennaproxen
    68071-3066naproxennaproxen
    68071-3387NaproxenNaproxen
    68071-3345NAPROXENNAPROXEN
    68071-4510NAPROXENNAPROXEN
    68071-4381NAPROXENNAPROXEN
    68134-201NaproxenNaproxen
    68151-2894NaproxenNaproxen
    68151-2609NaproxenNaproxen
    68151-2895NaproxenNaproxen
    68382-012NaproxenNaproxen
    68382-013NaproxenNaproxen
    68382-014NaproxenNaproxen
    68387-800NaproxenNaproxen
    68387-801NaproxenNaproxen
    68387-802NaproxenNaproxen
    68462-190NaproxenNaproxen
    68462-189NaproxenNaproxen
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