FDA.reportPublic FDA data

Probenecid

Product NDC
0591-5347
11-digit product format
005915347
Labeler code
0591
Product ID
0591-5347_8319745d-3201-48c6-b1eb-9ff32e930872
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Probenecid
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Actavis Pharma, Inc.
Application
ANDA084442
Marketing category
ANDA
Marketing start
1983-07-01
Substance
PROBENECID
Active strength
500 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Probenecid
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PROBENECID500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiPO572Z7917
Rxcui198152

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e312405-bfef-73b2-fc56-fea2b3b68305Product name220250731
51989a2b-944a-b31f-835e-469c133570adProduct name220250716

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0591-5347-01Probenecid100 in 1 BOTTLE, PLASTICTABLET, FILM COATED10013
0591-5347-10Probenecid1000 in 1 BOTTLE, PLASTICTABLET, FILM COATED100013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0591-5347-01EA - Each0591-5347b7c2012b-0b70-423e-a5b9-b9bdc2d94eb512012-07-24
0591-5347-10EA - Each0591-534781816020-2e09-4ed7-a08a-0d840f92151e12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PROBENECIDACTIVE INGREDIENTPO572Z7917PROBENECID TABLET, FILM COATED [WATSON LABORATORIES, INC.]4
PROBENECIDACTIVE MOIETYPO572Z7917PROBENECID TABLET, FILM COATED [WATSON LABORATORIES, INC.]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPROBENECID TABLET, FILM COATED [WATSON LABORATORIES, INC.]4
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GPROBENECID TABLET, FILM COATED [WATSON LABORATORIES, INC.]4
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPROBENECID TABLET, FILM COATED [WATSON LABORATORIES, INC.]4
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8PROBENECID TABLET, FILM COATED [WATSON LABORATORIES, INC.]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPROBENECID TABLET, FILM COATED [WATSON LABORATORIES, INC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PROBENECID TABLET, FILM COATED [WATSON LABORATORIES, INC.]4
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1APROBENECID TABLET, FILM COATED [WATSON LABORATORIES, INC.]4
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HPROBENECID TABLET, FILM COATED [WATSON LABORATORIES, INC.]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PROBENECID TABLET, FILM COATED [WATSON LABORATORIES, INC.]4
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JPROBENECID TABLET, FILM COATED [WATSON LABORATORIES, INC.]4
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2PROBENECID TABLET, FILM COATED [WATSON LABORATORIES, INC.]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPROBENECID TABLET, FILM COATED [WATSON LABORATORIES, INC.]4
PROBENECIDACTIVE INGREDIENTPO572Z7917PROBENECID TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
PROBENECIDACTIVE MOIETYPO572Z7917PROBENECID TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPROBENECID TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GPROBENECID TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPROBENECID TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8PROBENECID TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPROBENECID TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PROBENECID TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1APROBENECID TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HPROBENECID TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PROBENECID TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JPROBENECID TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2PROBENECID TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPROBENECID TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
ProbenecidACTIVE INGREDIENTPO572Z7917PROBENECID TABLET, FILM COATED [HHS/PROGRAM SUPPORT CENTER/SUPPLY SERVICE CENTER]1
ProbenecidACTIVE MOIETYPO572Z7917PROBENECID TABLET, FILM COATED [HHS/PROGRAM SUPPORT CENTER/SUPPLY SERVICE CENTER]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPROBENECID TABLET, FILM COATED [HHS/PROGRAM SUPPORT CENTER/SUPPLY SERVICE CENTER]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GPROBENECID TABLET, FILM COATED [HHS/PROGRAM SUPPORT CENTER/SUPPLY SERVICE CENTER]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPROBENECID TABLET, FILM COATED [HHS/PROGRAM SUPPORT CENTER/SUPPLY SERVICE CENTER]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8PROBENECID TABLET, FILM COATED [HHS/PROGRAM SUPPORT CENTER/SUPPLY SERVICE CENTER]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPROBENECID TABLET, FILM COATED [HHS/PROGRAM SUPPORT CENTER/SUPPLY SERVICE CENTER]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PROBENECID TABLET, FILM COATED [HHS/PROGRAM SUPPORT CENTER/SUPPLY SERVICE CENTER]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1APROBENECID TABLET, FILM COATED [HHS/PROGRAM SUPPORT CENTER/SUPPLY SERVICE CENTER]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HPROBENECID TABLET, FILM COATED [HHS/PROGRAM SUPPORT CENTER/SUPPLY SERVICE CENTER]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PROBENECID TABLET, FILM COATED [HHS/PROGRAM SUPPORT CENTER/SUPPLY SERVICE CENTER]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JPROBENECID TABLET, FILM COATED [HHS/PROGRAM SUPPORT CENTER/SUPPLY SERVICE CENTER]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2PROBENECID TABLET, FILM COATED [HHS/PROGRAM SUPPORT CENTER/SUPPLY SERVICE CENTER]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPROBENECID TABLET, FILM COATED [HHS/PROGRAM SUPPORT CENTER/SUPPLY SERVICE CENTER]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0591-5347PROBENECID TABLET, FILM COATED [ACTAVIS PHARMA, INC.]13Current NDC, Legacy NDC, 2 package rows20250509_ae126418-5474-4fbe-b83c-bde8b2b4ae6e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198152probenecid 500 MG Oral TabletPSNae126418-5474-4fbe-b83c-bde8b2b4ae6e13
198152probenecid 500 MG Oral TabletSCDae126418-5474-4fbe-b83c-bde8b2b4ae6e13
198152probenecid 500 MG Oral TabletPSN9eeedc83-f6cc-4383-83ec-d7992a96b7b43
198152probenecid 500 MG Oral TabletSCD9eeedc83-f6cc-4383-83ec-d7992a96b7b43
198152probenecid 500 MG Oral TabletPSN5ca3dd4c-b8b4-4131-a066-214dabb2576f1
198152probenecid 500 MG Oral TabletSCD5ca3dd4c-b8b4-4131-a066-214dabb2576f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0591-5347-0100591534701100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0591-5347-01) 1983-07-010000-00-00NoNoCurrent
0591-5347-10005915347101000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0591-5347-10) 1983-07-010000-00-00NoNoCurrent