Probenecid and Colchicine
Probenecid and Colchicine Tablets USP Rx only
Approved
Approval ID
3d2a3d4f-38a3-4669-ad78-ab1d7aef4ec3
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 6, 2023
Manufacturers
FDA
Rising Pharma Holdings, Inc.
DUNS: 116880195
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 Code16571-832
Application NumberANDA217030
Product Classification
M
Marketing Category
C73584
G
Generic Name
Probenecid and Colchicine
Product Specifications
Route of AdministrationORAL
Effective DateNovember 6, 2023
FDA Product Classification
INGREDIENTS (9)
COLCHICINEActive
Quantity: 0.5 mg in 1 1
Code: SML2Y3J35T
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSE 101Inactive
Code: 7T9FYH5QMK
Classification: IACT
PROBENECIDActive
Quantity: 500 mg in 1 1
Code: PO572Z7917
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
POVIDONE K90Inactive
Code: RDH86HJV5Z
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT