COLCHICINE
COLCHICINE
Approved
Approval ID
c7d013b7-0a67-0953-e053-2a95a90ac47c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 23, 2021
Manufacturers
FDA
direct rx
DUNS: 079254320
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
COLCHICINE
PRODUCT DETAILS
NDC Product Code72189-249
Application NumberNDA022352
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateJuly 23, 2021
Generic NameCOLCHICINE
INGREDIENTS (14)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IE
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
COLCHICINEActive
Quantity: 0.6 mg in 1 1
Code: SML2Y3J35T
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT