Probenecid
Probenecid Tablets USPRevised: June 2009Rx only 190811
Approved
Approval ID
9eeedc83-f6cc-4383-83ec-d7992a96b7b4
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 23, 2012
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
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 Code54868-0159
Application NumberANDA084442
Product Classification
M
Marketing Category
C73584
G
Generic Name
Probenecid
Product Specifications
Route of AdministrationORAL
Effective DateOctober 23, 2012
FDA Product Classification
INGREDIENTS (13)
PROBENECIDActive
Quantity: 500 mg in 1 1
Code: PO572Z7917
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT