NDC 13310-119

Colcrys

Colchicine

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

Product ID13310-119_d6eb54b7-2050-4449-85b8-1592cec62176
NDC13310-119
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 NameAR Scientific Inc.
Substance NameCOLCHICINE
Active Ingredient Strength1 mg/1
Pharm ClassesCytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Interactions [MoA]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 13310-119-05

500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (13310-119-05)
Marketing Start Date2009-09-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 13310-119-06 [13310011906]

Colcrys TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA022352
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-09-01
Inactivation Date2019-11-13

NDC 13310-119-07 [13310011907]

Colcrys TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA022352
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-09-01
Inactivation Date2019-11-13

NDC 13310-119-03 [13310011903]

Colcrys TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA022352
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-09-01
Inactivation Date2019-11-13

NDC 13310-119-10 [13310011910]

Colcrys TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA022352
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-09-01
Inactivation Date2019-11-13

NDC 13310-119-05 [13310011905]

Colcrys TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA022352
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-09-01
Inactivation Date2019-11-13

NDC 13310-119-01 [13310011901]

Colcrys TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA022352
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-09-01
Inactivation Date2019-11-13

Drug Details

Active Ingredients

IngredientStrength
COLCHICINE.6 mg/1

OpenFDA Data

SPL SET ID:5ecaa34e-1bed-49a5-b97c-a8f8c0d885a7
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 197541
  • 858071

    • Pharmacological Class

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

    Medicade Reported Pricing

    13310011907 COLCRYS 0.6 MG TABLET

    Pricing Unit: EA | Drug Type:

    13310011901 COLCRYS 0.6 MG TABLET

    Pricing Unit: EA | Drug Type:

    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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