NDC 63629-3795

Naproxen

Naproxen

Naproxen is a Oral Tablet, Delayed Release in the Human Prescription Drug category. It is labeled and distributed by Bryant Ranch Prepack. The primary component is Naproxen.

Product ID63629-3795_862d4da9-d378-45b9-8c86-ba1b57c97c2b
NDC63629-3795
Product TypeHuman Prescription Drug
Proprietary NameNaproxen
Generic NameNaproxen
Dosage FormTablet, Delayed Release
Route of AdministrationORAL
Marketing Start Date1998-07-29
Marketing CategoryANDA / ANDA
Application NumberANDA075227
Labeler NameBryant Ranch Prepack
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 63629-3795-4

100 TABLET, DELAYED RELEASE in 1 BOTTLE (63629-3795-4)
Marketing Start Date2005-12-06
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63629-3795-8 [63629379508]

Naproxen TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA075227
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2005-12-06
Inactivation Date2020-01-31

NDC 63629-3795-5 [63629379505]

Naproxen TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA075227
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2005-12-06
Inactivation Date2020-01-31

NDC 63629-3795-2 [63629379502]

Naproxen TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA075227
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2005-12-06
Inactivation Date2020-01-31

NDC 63629-3795-4 [63629379504]

Naproxen TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA075227
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2005-12-06
Inactivation Date2020-01-31

NDC 63629-3795-6 [63629379506]

Naproxen TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA075227
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-09-24
Inactivation Date2020-01-31

NDC 63629-3795-1 [63629379501]

Naproxen TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA075227
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2005-12-06
Inactivation Date2020-01-31

NDC 63629-3795-7 [63629379507]

Naproxen TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA075227
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-09-24
Inactivation Date2020-01-31

NDC 63629-3795-3 [63629379503]

Naproxen TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA075227
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2005-12-06
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
NAPROXEN500 mg/1

OpenFDA Data

SPL SET ID:669e5dc4-21ef-7a2d-d232-edc47c5716c5
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]
    • 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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