NDC 12634-684

Naproxen

Naproxen

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

Product ID12634-684_27fec1d8-54db-4fed-e054-00144ff88e88
NDC12634-684
Product TypeHuman Prescription Drug
Proprietary NameNaproxen
Generic NameNaproxen
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2007-07-01
Marketing CategoryANDA / ANDA
Application NumberANDA078250
Labeler NameApotheca 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 12634-684-59

30 TABLET in 1 BLISTER PACK (12634-684-59)
Marketing Start Date2007-07-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 12634-684-91 [12634068491]

Naproxen TABLET
Marketing CategoryANDA
Application NumberANDA078250
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2007-07-01
Inactivation Date2020-01-31

NDC 12634-684-66 [12634068466]

Naproxen TABLET
Marketing CategoryANDA
Application NumberANDA078250
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2007-07-01
Inactivation Date2020-01-31

NDC 12634-684-81 [12634068481]

Naproxen TABLET
Marketing CategoryANDA
Application NumberANDA078250
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2007-07-01
Inactivation Date2020-01-31

NDC 12634-684-54 [12634068454]

Naproxen TABLET
Marketing CategoryANDA
Application NumberANDA078250
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2007-07-01
Inactivation Date2020-01-31

NDC 12634-684-40 [12634068440]

Naproxen TABLET
Marketing CategoryANDA
Application NumberANDA078250
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2007-07-01
Inactivation Date2020-01-31

NDC 12634-684-84 [12634068484]

Naproxen TABLET
Marketing CategoryANDA
Application NumberANDA078250
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2007-07-01
Inactivation Date2020-01-31

NDC 12634-684-58 [12634068458]

Naproxen TABLET
Marketing CategoryANDA
Application NumberANDA078250
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2007-07-01
Inactivation Date2020-01-31

NDC 12634-684-60 [12634068460]

Naproxen TABLET
Marketing CategoryANDA
Application NumberANDA078250
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2007-07-01
Inactivation Date2020-01-31

NDC 12634-684-61 [12634068461]

Naproxen TABLET
Marketing CategoryANDA
Application NumberANDA078250
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2007-07-01
Inactivation Date2020-01-31

NDC 12634-684-71 [12634068471]

Naproxen TABLET
Marketing CategoryANDA
Application NumberANDA078250
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2007-07-01
Inactivation Date2020-01-31

NDC 12634-684-74 [12634068474]

Naproxen TABLET
Marketing CategoryANDA
Application NumberANDA078250
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2007-07-01
Inactivation Date2020-01-31

NDC 12634-684-00 [12634068400]

Naproxen TABLET
Marketing CategoryANDA
Application NumberANDA078250
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2007-07-01
Inactivation Date2020-01-31

NDC 12634-684-01 [12634068401]

Naproxen TABLET
Marketing CategoryANDA
Application NumberANDA078250
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2007-07-01
Inactivation Date2020-01-31

NDC 12634-684-59 [12634068459]

Naproxen TABLET
Marketing CategoryANDA
Application NumberANDA078250
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2007-07-01
Inactivation Date2020-01-31

NDC 12634-684-80 [12634068480]

Naproxen TABLET
Marketing CategoryANDA
Application NumberANDA078250
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2007-07-01
Inactivation Date2020-01-31

NDC 12634-684-15 [12634068415]

Naproxen TABLET
Marketing CategoryANDA
Application NumberANDA078250
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2007-07-01
Marketing End Date2015-12-28

NDC 12634-684-57 [12634068457]

Naproxen TABLET
Marketing CategoryANDA
Application NumberANDA078250
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2007-07-01
Inactivation Date2020-01-31

NDC 12634-684-96 [12634068496]

Naproxen TABLET
Marketing CategoryANDA
Application NumberANDA078250
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2007-07-01
Inactivation Date2020-01-31

NDC 12634-684-55 [12634068455]

Naproxen TABLET
Marketing CategoryANDA
Application NumberANDA078250
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-12-28
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
NAPROXEN500 mg/1

OpenFDA Data

SPL SET ID:27ab4f1a-2f2b-150c-e054-00144ff8d46c
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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