Probenecid
PROBENECID
Approved
Approval ID
5d552de5-2d18-4464-bcaf-0311fa3f080d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 15, 2023
Manufacturers
FDA
Marlex Pharmaceuticals Inc
DUNS: 782540215
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Probenecid
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code10135-541
Application NumberANDA080966
Product Classification
M
Marketing Category
C73584
G
Generic Name
Probenecid
Product Specifications
Route of AdministrationORAL
Effective DateNovember 15, 2023
FDA Product Classification
INGREDIENTS (16)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
PROBENECIDActive
Quantity: 500 mg in 1 1
Code: PO572Z7917
Classification: ACTIB
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT