Probenecid and Colchicine
Probenecid and Colchicine Tablets, USP Rx only
Approved
Approval ID
b85d3e27-70ff-4533-b463-410e4fb23813
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 21, 2019
Manufacturers
FDA
Ingenus Pharmaceuticals, LLC
DUNS: 833250017
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Probenecid and Colchicine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50742-263
Application NumberANDA040618
Product Classification
M
Marketing Category
C73584
G
Generic Name
Probenecid and Colchicine
Product Specifications
Route of AdministrationORAL
Effective DateMay 21, 2019
FDA Product Classification
INGREDIENTS (7)
COLCHICINEActive
Quantity: 0.5 mg in 1 1
Code: SML2Y3J35T
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
PROBENECIDActive
Quantity: 500 mg in 1 1
Code: PO572Z7917
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT