NDC 49999-383

CELEBREX

Celecoxib

CELEBREX is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Lake Erie Medical Dba Quality Care Products Llc. The primary component is Celecoxib.

Product ID49999-383_836e2ffd-c264-4ca6-8882-c352941e53bf
NDC49999-383
Product TypeHuman Prescription Drug
Proprietary NameCELEBREX
Generic NameCelecoxib
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2011-11-22
Marketing CategoryNDA / NDA
Application NumberNDA020998
Labeler NameLake Erie Medical DBA Quality Care Products LLC
Substance NameCELECOXIB
Active Ingredient Strength100 mg/1
Pharm ClassesCyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC SPL Data Element Entries

NDC 49999-383-30 [49999038330]

CELEBREX CAPSULE
Marketing CategoryNDA
Application NumberNDA020998
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-11-22
Marketing End Date2016-12-01
Inactivation Date2020-01-31

NDC 49999-383-60 [49999038360]

CELEBREX CAPSULE
Marketing CategoryNDA
Application NumberNDA020998
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-11-22
Marketing End Date2016-12-01
Inactivation Date2020-01-31

NDC 49999-383-10 [49999038310]

CELEBREX CAPSULE
Marketing CategoryNDA
Application NumberNDA020998
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-11-22
Marketing End Date2016-12-01
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
CELECOXIB100 mg/1

OpenFDA Data

SPL SET ID:2aea0f50-b823-42ba-ab13-b40168bd55a2
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 213468
  • 205322
  • 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 "CELEBREX" or generic name "Celecoxib"

    NDCBrand NameGeneric Name
    0025-1515CELEBREXCelecoxib
    0025-1520CELEBREXCelecoxib
    0025-1525CELEBREXCelecoxib
    0025-1530CELEBREXCelecoxib
    68387-552CELEBREXCELEBREX
    68788-0768CELEBREXCELEBREX
    21695-023CELEBREXCELEBREX
    21695-022CELEBREXCELEBREX
    33261-019CELEBREXCELEBREX
    49999-383CELEBREXCELEBREX
    52959-540CELEBREXCELEBREX
    52959-539CELEBREXCELEBREX
    55154-3621CELEBREXCELEBREX
    55154-3622CELEBREXCELEBREX
    55289-451CELEBREXCELEBREX
    55154-3625CELEBREXCELEBREX
    55289-475CELEBREXCELEBREX
    61919-046CELEBREXCELEBREX
    63187-079CELEBREXCELEBREX
    63629-6368CELEBREXCELEBREX
    63629-3021CELEBREXCELEBREX
    66336-940CELEBREXCELEBREX
    67544-204CELEBREXCELEBREX
    80425-0096CelebrexCelebrex
    80425-0038CelebrexCelebrex
    80425-0040CelebrexCelebrex
    80425-0037CelebrexCelebrex
    80425-0039CelebrexCelebrex
    0093-7165CelecoxibCelecoxib
    0093-7166CelecoxibCelecoxib
    0093-7170CelecoxibCelecoxib
    0093-7306CelecoxibCelecoxib

    Trademark Results [CELEBREX]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    CELEBREX
    CELEBREX
    88814821 not registered Live/Pending
    G. D. Searle LLC
    2020-02-28
    CELEBREX
    CELEBREX
    75655826 2321622 Live/Registered
    G. D. SEARLE LLC
    1999-03-08
    CELEBREX
    CELEBREX
    75432043 2307888 Live/Registered
    G. D. SEARLE LLC
    1998-02-10

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.