Colchicine
Rx OnlyThese highlights do not include all the information needed to use COLCHICINE CAPSULES safely and effectively. See full prescribing information for COLCHICINE CAPSULES. COLCHICINE capsules, for oral useInitial U.S. Approval: 1961
Approved
Approval ID
25307250-c16b-4467-9ad0-e6c752c576bd
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 12, 2023
Manufacturers
FDA
A-S Medication Solutions
DUNS: 830016429
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 Code50090-3465
Application NumberNDA204820
Product Classification
M
Marketing Category
C73594
G
Generic Name
Colchicine
Product Specifications
Route of AdministrationORAL
Effective DateMarch 5, 2023
FDA Product Classification
INGREDIENTS (14)
COLCHICINEActive
Quantity: 0.6 mg in 1 1
Code: SML2Y3J35T
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
D&C RED NO. 28Inactive
Code: 767IP0Y5NH
Classification: CNTM
FD&C RED NO. 3Inactive
Code: PN2ZH5LOQY
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: CNTM
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: CNTM