NDC 70518-0636

Naproxen

Naproxen

Naproxen is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Remedyrepack Inc.. The primary component is Naproxen.

Product ID70518-0636_798e3f77-56c6-aac3-e053-2991aa0adaae
NDC70518-0636
Product TypeHuman Prescription Drug
Proprietary NameNaproxen
Generic NameNaproxen
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2017-07-25
Marketing CategoryANDA / ANDA
Application NumberANDA078250
Labeler NameREMEDYREPACK INC.
Substance NameNAPROXEN
Active Ingredient Strength500 mg/1
Pharm ClassesCyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 70518-0636-2

30 TABLET in 1 BOTTLE, PLASTIC (70518-0636-2)
Marketing Start Date2018-04-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70518-0636-0 [70518063600]

Naproxen TABLET
Marketing CategoryANDA
Application NumberANDA078250
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-07-25
Marketing End Date2020-04-07
Inactivation Date2020-01-31
Reactivation Date2020-04-07

NDC 70518-0636-2 [70518063602]

Naproxen TABLET
Marketing CategoryANDA
Application NumberANDA078250
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-04-10
Marketing End Date2020-04-07
Inactivation Date2020-01-31
Reactivation Date2020-04-07

NDC 70518-0636-1 [70518063601]

Naproxen TABLET
Marketing CategoryANDA
Application NumberANDA078250
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-10-26
Marketing End Date2020-04-07
Inactivation Date2020-01-31
Reactivation Date2020-04-07

NDC 70518-0636-3 [70518063603]

Naproxen TABLET
Marketing CategoryANDA
Application NumberANDA078250
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-05-15
Marketing End Date2020-04-07
Inactivation Date2020-01-31
Reactivation Date2020-04-07

NDC 70518-0636-4 [70518063604]

Naproxen TABLET
Marketing CategoryANDA
Application NumberANDA078250
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-10-30
Marketing End Date2020-04-07
Inactivation Date2020-01-31
Reactivation Date2020-04-07

Drug Details

Active Ingredients

IngredientStrength
NAPROXEN500 mg/1

OpenFDA Data

SPL SET ID:fb735255-0bc4-43d1-b761-052b04a9e911
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 198014
    • 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]
    • Anti-Inflammatory Agents
    • Non-Steroidal [CS]

    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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