NDC 63187-292

Colcrys

Colchicine

Colcrys is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Proficient Rx Lp. The primary component is Colchicine.

Product ID63187-292_22de52fb-eba3-4142-816a-f6e9bd03fff5
NDC63187-292
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 NameProficient Rx LP
Substance NameCOLCHICINE
Active Ingredient Strength1 mg/1
Pharm ClassesCytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Interactions [MoA]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 63187-292-03

3 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63187-292-03)
Marketing Start Date2019-01-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63187-292-03 [63187029203]

Colcrys TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA022352
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-01-01

Drug Details

Active Ingredients

IngredientStrength
COLCHICINE.6 mg/1

OpenFDA Data

SPL SET ID:d6adc880-5499-4691-93f3-27c87902d5fc
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 197541
  • 858071

    • 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 "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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