FDA.reportPublic FDA data

Probenecid

Product NDC
10135-541
11-digit product format
101350541
Labeler code
10135
Product ID
10135-541_43e0b999-0f40-3c9d-e063-6294a90ae477
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Probenecid
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Marlex Pharmaceuticals Inc
Application
ANDA080966
Marketing category
ANDA
Marketing start
1976-07-29
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10135-541-012021-02-11C16284748780-1ba0f9c33-3c5a-a910-e053-dadaa90a0b85PROBENECID
10135-541-102021-02-11C16284748780-1ba0f9c33-3c5a-a910-e053-dadaa90a0b85PROBENECID
10135-541-012021-01-29C16284748780-1ba0f9c33-3c5a-a910-e053-dadaa90a0b85PROBENECID
10135-541-102021-01-29C16284748780-1ba0f9c33-3c5a-a910-e053-dadaa90a0b85PROBENECID

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10135-541-01Probenecid100 in 1 BOTTLETABLET, FILM COATED10011
10135-541-10Probenecid1000 in 1 BOTTLETABLET, FILM COATED100011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10135-541-01EA - Each10135-541c1bd0608-f473-4fb7-a696-04b35973063a12019-08-06
10135-541-10EA - Each10135-541ece07e2b-dc9a-45b4-bea8-c36fb413023412013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PROBENECIDACTIVE INGREDIENTPO572Z7917PROBENECID TABLET, FILM COATED [MARLEX PHARMACEUTICALS INC]2
PROBENECIDACTIVE MOIETYPO572Z7917PROBENECID TABLET, FILM COATED [MARLEX PHARMACEUTICALS INC]2
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933PROBENECID TABLET, FILM COATED [MARLEX PHARMACEUTICALS INC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPROBENECID TABLET, FILM COATED [MARLEX PHARMACEUTICALS INC]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GPROBENECID TABLET, FILM COATED [MARLEX PHARMACEUTICALS INC]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKPROBENECID TABLET, FILM COATED [MARLEX PHARMACEUTICALS INC]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8PROBENECID TABLET, FILM COATED [MARLEX PHARMACEUTICALS INC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PROBENECID TABLET, FILM COATED [MARLEX PHARMACEUTICALS INC]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1APROBENECID TABLET, FILM COATED [MARLEX PHARMACEUTICALS INC]2
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990PROBENECID TABLET, FILM COATED [MARLEX PHARMACEUTICALS INC]2
POVIDONE K29/32INACTIVE INGREDIENT390RMW2PEQPROBENECID TABLET, FILM COATED [MARLEX PHARMACEUTICALS INC]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PROBENECID TABLET, FILM COATED [MARLEX PHARMACEUTICALS INC]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JPROBENECID TABLET, FILM COATED [MARLEX PHARMACEUTICALS INC]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2PROBENECID TABLET, FILM COATED [MARLEX PHARMACEUTICALS INC]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPROBENECID TABLET, FILM COATED [MARLEX PHARMACEUTICALS INC]2
TALCINACTIVE INGREDIENT7SEV7J4R1UPROBENECID TABLET, FILM COATED [MARLEX PHARMACEUTICALS INC]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPROBENECID TABLET, FILM COATED [MARLEX PHARMACEUTICALS INC]2
PROBENECIDACTIVE INGREDIENTPO572Z7917PROBENECID TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
PROBENECIDACTIVE MOIETYPO572Z7917PROBENECID TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933PROBENECID TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPROBENECID TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GPROBENECID TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKPROBENECID TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8PROBENECID TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PROBENECID TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1APROBENECID TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990PROBENECID TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
POVIDONE K29/32INACTIVE INGREDIENT390RMW2PEQPROBENECID TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PROBENECID TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JPROBENECID TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2PROBENECID TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPROBENECID TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
TALCINACTIVE INGREDIENT7SEV7J4R1UPROBENECID TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPROBENECID TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10135-541PROBENECID TABLET, FILM COATED [MARLEX PHARMACEUTICALS INC]10Current NDC, Legacy NDC, 2 package rows20241018_5d552de5-2d18-4464-bcaf-0311fa3f080d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198152probenecid 500 MG Oral TabletPSN5d552de5-2d18-4464-bcaf-0311fa3f080d11
198152probenecid 500 MG Oral TabletSCD5d552de5-2d18-4464-bcaf-0311fa3f080d11
198152probenecid 500 MG Oral TabletPSN14637e17-4265-4195-8182-7ca13796c6841
198152probenecid 500 MG Oral TabletSCD14637e17-4265-4195-8182-7ca13796c6841

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
10135-541-0110135054101100 TABLET, FILM COATED in 1 BOTTLE (10135-541-01) 1976-07-290000-00-00NoNoCurrent
10135-541-10101350541101000 TABLET, FILM COATED in 1 BOTTLE (10135-541-10) 1976-07-290000-00-00NoNoCurrent