NDC 43353-854

Colcrys

Colchicine

Colcrys is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Aphena Pharma Solutions - Tennessee, Llc. The primary component is Colchicine.

Product ID43353-854_31cb7052-4226-4ab2-96c2-8a7fe4714d82
NDC43353-854
Product TypeHuman Prescription Drug
Proprietary NameColcrys
Generic NameColchicine
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2009-09-01
Marketing CategoryNDA / NDA
Application NumberNDA022352
Labeler NameAphena Pharma Solutions - Tennessee, LLC
Substance NameCOLCHICINE
Active Ingredient Strength1 mg/1
Pharm ClassesCytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Interactions [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 43353-854-09

9000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-854-09)
Marketing Start Date2013-07-02
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 43353-854-09 [43353085409]

Colcrys TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA022352
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-07-02

Drug Details

Active Ingredients

IngredientStrength
COLCHICINE.6 mg/1

OpenFDA Data

SPL SET ID:a80036fe-3016-4541-aa42-6c06cf37ae55
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 197541
  • 858071

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    13310-119ColcrysColchicine
    43353-854ColcrysColchicine
    63187-292ColcrysColchicine
    64764-119ColcrysColcrys
    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
    59467-318MITIGAREColchicine

    Trademark Results [Colcrys]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    COLCRYS
    COLCRYS
    77978156 3716922 Live/Registered
    TAKEDA PHARMACEUTICALS U.S.A., INC.
    2008-12-18
    COLCRYS
    COLCRYS
    77636223 3842336 Live/Registered
    Takeda Pharmaceuticals U.S.A., Inc.
    2008-12-18
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