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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

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Probenecid and Colchicine - FDA Drug Approval Details