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Probenecid

Probenecid, Tablets USP

Approved
Approval ID

38a2d4c1-e329-2dbb-e054-00144ff8d46c

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jul 27, 2016

Manufacturers
FDA

Westminster Pharmaceuticals, LLC

DUNS: 079516651

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 Code69367-154
Application NumberANDA084442
Product Classification
M
Marketing Category
C73584
G
Generic Name
Probenecid
Product Specifications
Route of AdministrationORAL
Effective DateJuly 27, 2016
FDA Product Classification

INGREDIENTS (13)

SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
PROBENECIDActive
Quantity: 500 mg in 1 1
Code: PO572Z7917
Classification: ACTIB
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT

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Probenecid - FDA Drug Approval Details