NDC 72690-010

Gloperba

Colchicine

Gloperba is a Oral Solution in the Human Prescription Drug category. It is labeled and distributed by Romeg Therapeutics, Llc. The primary component is Colchicine.

Product ID72690-010_3a77b97f-df41-4712-9b4d-93a9fa64e3c2
NDC72690-010
Product TypeHuman Prescription Drug
Proprietary NameGloperba
Generic NameColchicine
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2019-08-01
Marketing CategoryNDA / NDA
Application NumberNDA210942
Labeler NameROMEG Therapeutics, LLC
Substance NameCOLCHICINE
Active Ingredient Strength1 mg/5mL
Pharm ClassesCytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Interactions [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 72690-010-05

150 mL in 1 BOTTLE, PLASTIC (72690-010-05)
Marketing Start Date2019-08-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 72690-010-05 [72690001005]

Gloperba SOLUTION
Marketing CategoryNDA
Application NumberNDA210942
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-08-01

Drug Details

Active Ingredients

IngredientStrength
COLCHICINE.6 mg/5mL

OpenFDA Data

SPL SET ID:6971137c-deef-4309-909e-552f1930999d
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 2180558
  • 2118892
    • UPC Code
  • 0372690010059

    • Pharmacological Class

    • Cytochrome P450 3A4 Inhibitors [MoA]
    • P-Glycoprotein Interactions [MoA]
    • Cytochrome P450 3A4 Inhibitors [MoA]
    • P-Glycoprotein Interactions [MoA]

    NDC Crossover Matching brand name "Gloperba" or generic name "Colchicine"

    NDCBrand NameGeneric Name
    75854-801GloperbaGloperba
    72690-010GloperbaGloperba
    0143-3018ColchicineColchicine
    0254-2008ColchicineColchicine
    0378-1086ColchicineColchicine
    0591-2562ColchicineColchicine
    0904-6732ColchicineColchicine
    0904-7120ColchicineColchicine
    16714-039ColchicineColchicine
    31722-899ColchicineColchicine
    42292-054ColchicineColchicine
    43598-372colchicinecolchicine
    49884-171Colchicinecolchicine
    50090-3465ColchicineColchicine
    50268-187ColchicineColchicine
    51407-082ColchicineColchicine
    59651-455ColchicineColchicine
    60687-358ColchicineColchicine
    60687-389ColchicineColchicine
    13310-119ColcrysColchicine
    43353-854ColcrysColchicine
    63187-292ColcrysColchicine
    59467-318MITIGAREColchicine

    Trademark Results [Gloperba]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    GLOPERBA
    GLOPERBA
    98273093 not registered Live/Pending
    RxOMEG Therapeutics LLC
    2023-11-16
    GLOPERBA
    GLOPERBA
    86871218 5219373 Live/Registered
    RxOMEG Therapeutics LLC
    2016-01-11
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