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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72189-249
Application NumberNDA022352
Product Classification
M
Marketing Category
C73594
G
Generic Name
COLCHICINE
Product Specifications
Route of AdministrationORAL
Effective DateJuly 23, 2021
FDA Product Classification
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