Colchicine
Rx Only These 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 use Initial U.S. Approval: 1961
Approved
Approval ID
2f5e24de-3956-4724-a5d7-fe81dcb07f6e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 4, 2022
Manufacturers
FDA
American Health Packaging
DUNS: 929561009
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 Code60687-358
Application NumberNDA204820
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateOctober 4, 2022
Generic NameColchicine
INGREDIENTS (12)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
FD&C RED NO. 3Inactive
Code: PN2ZH5LOQY
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
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
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT