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Probenecid

Probenecid Tablets USP, 500 mg Rx only

Approved
Approval ID

f2375d90-4132-4fb6-aee7-c4f9d11e98d5

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Nov 28, 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

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code16571-831
Application NumberANDA217020
Product Classification
M
Marketing Category
C73584
G
Generic Name
Probenecid
Product Specifications
Route of AdministrationORAL
Effective DateNovember 28, 2023
FDA Product Classification

INGREDIENTS (15)

SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
PROBENECIDActive
Quantity: 500 mg in 1 1
Code: PO572Z7917
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSE 101Inactive
Code: 7T9FYH5QMK
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
POLYETHYLENE GLYCOL 4000Inactive
Code: 4R4HFI6D95
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990
Classification: IACT
POVIDONE K90Inactive
Code: RDH86HJV5Z
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT

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Probenecid - FDA Drug Approval Details