Colchicine
Colchicine Tablets USP, 0.6 mg These highlights do not include all the information needed to use colchicine safely and effectively. See full prescribing information for COLCHICINE TABLETS. COLCHICINE tablets, USP for oral use Initial U.S. Approval: 1961
Approved
Approval ID
9e7c8f65-4722-4187-9014-8fa81eb5681e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 26, 2022
Manufacturers
FDA
Major Pharmaceuticals
DUNS: 191427277
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 Code0904-7120
Application NumberANDA210425
Product Classification
M
Marketing Category
C73584
G
Generic Name
Colchicine
Product Specifications
Route of AdministrationORAL
Effective DateMay 18, 2021
FDA Product Classification
INGREDIENTS (13)
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IE
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
COLCHICINEActive
Quantity: 0.6 mg in 1 1
Code: SML2Y3J35T
Classification: ACTIB
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT