NDC 43063-650

Naproxen

Naproxen

Naproxen is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Pd-rx Pharmaceuticals, In. The primary component is Naproxen.

Product ID43063-650_77f96b01-73cc-4602-e053-2a91aa0a3ece
NDC43063-650
Product TypeHuman Prescription Drug
Proprietary NameNaproxen
Generic NameNaproxen
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2010-02-18
Marketing CategoryANDA / ANDA
Application NumberANDA075927
Labeler NamePD-Rx Pharmaceuticals, In
Substance NameNAPROXEN
Active Ingredient Strength375 mg/1
Pharm ClassesCyclooxygenase
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 43063-650-06

6 TABLET in 1 BOTTLE, PLASTIC (43063-650-06)
Marketing Start Date2016-01-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 43063-650-42 [43063065042]

Naproxen TABLET
Marketing CategoryANDA
Application NumberANDA075927
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-01-22

NDC 43063-650-24 [43063065024]

Naproxen TABLET
Marketing CategoryANDA
Application NumberANDA075927
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-01-22

NDC 43063-650-06 [43063065006]

Naproxen TABLET
Marketing CategoryANDA
Application NumberANDA075927
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-01-22

NDC 43063-650-15 [43063065015]

Naproxen TABLET
Marketing CategoryANDA
Application NumberANDA075927
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-01-22

NDC 43063-650-21 [43063065021]

Naproxen TABLET
Marketing CategoryANDA
Application NumberANDA075927
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-01-22

NDC 43063-650-14 [43063065014]

Naproxen TABLET
Marketing CategoryANDA
Application NumberANDA075927
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-01-22

NDC 43063-650-20 [43063065020]

Naproxen TABLET
Marketing CategoryANDA
Application NumberANDA075927
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-01-22

NDC 43063-650-10 [43063065010]

Naproxen TABLET
Marketing CategoryANDA
Application NumberANDA075927
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-01-22

NDC 43063-650-60 [43063065060]

Naproxen TABLET
Marketing CategoryANDA
Application NumberANDA075927
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-01-22

NDC 43063-650-30 [43063065030]

Naproxen TABLET
Marketing CategoryANDA
Application NumberANDA075927
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-01-22

Drug Details

Active Ingredients

IngredientStrength
NAPROXEN375 mg/1

OpenFDA Data

SPL SET ID:29d98cf3-a0f2-3f89-e054-00144ff88e88
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 198012
    • PHarm Class EPC
  • Nonsteroidal Anti-inflammatory Drug [EPC]
    • UPC Code
  • 0343063650202
    • 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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