NDC 42292-054

Colchicine

Colchicine

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

Product ID42292-054_a23dc10c-f0be-f3a4-e053-2a95a90abea0
NDC42292-054
Product TypeHuman Prescription Drug
Proprietary NameColchicine
Generic NameColchicine
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2020-03-25
Marketing CategoryANDA / ANDA
Application NumberANDA209470
Labeler NameMylan Institutional Inc.
Substance NameCOLCHICINE
Active Ingredient Strength1 mg/1
Pharm ClassesCytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Interactions [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 42292-054-03

30 BLISTER PACK in 1 CARTON (42292-054-03) > 1 TABLET, FILM COATED in 1 BLISTER PACK (42292-054-01)
Marketing Start Date2020-04-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 42292-054-01 [42292005401]

Colchicine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA209470
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2020-04-28

NDC 42292-054-03 [42292005403]

Colchicine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA209470
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2020-04-28

Drug Details

Active Ingredients

IngredientStrength
COLCHICINE.6 mg/1

OpenFDA Data

SPL SET ID:5d8d511a-0851-4d0a-a01a-f43398b63a06
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 197541

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    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
    67877-589colchicinecolchicine
    63629-7422ColchicineColchicine
    65162-710ColchicineColchicine
    66993-165ColchicineColchicine
    70710-1351ColchicineColchicine
    70771-1396ColchicineColchicine
    67296-1708ColchicineColchicine
    71205-310ColchicineColchicine
    70010-002ColchicineColchicine
    71335-1695colchicinecolchicine
    71610-494ColchicineColchicine
    71335-1738colchicinecolchicine
    63629-8362colchicinecolchicine
    13310-119ColcrysColchicine
    43353-854ColcrysColchicine
    63187-292ColcrysColchicine
    59467-318MITIGAREColchicine
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.