Probenecid

Product NDC
0527-1367
11-digit product format
005271367
Labeler code
0527
Product ID
0527-1367_8679dae4-b649-458d-962b-2afb0f491d2a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Probenecid
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Lannett Company, 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0527-1367-012024-01-30C16284748780-11030e365-103c-111a-e063-dadaa90a10e2Probenecid Tablets, USP 500 mg Rx Only
0527-1367-102024-01-30C16284748780-11030e365-103c-111a-e063-dadaa90a10e2Probenecid Tablets, USP 500 mg Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0527-1367-01Probenecid100 in 1 BOTTLETABLET, FILM COATED1009
0527-1367-10Probenecid1000 in 1 BOTTLETABLET, FILM COATED10009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0527-1367-01EA - Each0527-136771631b02-48bb-43df-83d5-67d7966b368c12012-07-24
0527-1367-10EA - Each0527-136747477709-3a89-47a8-a7cc-c079b342b3a512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PROBENECIDACTIVE INGREDIENTPO572Z7917PROBENECID TABLET, FILM COATED [LANNETT COMPANY, INC.]4
PROBENECIDACTIVE MOIETYPO572Z7917PROBENECID TABLET, FILM COATED [LANNETT COMPANY, INC.]4
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933PROBENECID TABLET, FILM COATED [LANNETT COMPANY, INC.]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPROBENECID TABLET, FILM COATED [LANNETT COMPANY, INC.]4
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PROBENECID TABLET, FILM COATED [LANNETT COMPANY, INC.]4
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GPROBENECID TABLET, FILM COATED [LANNETT COMPANY, INC.]4
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKPROBENECID TABLET, FILM COATED [LANNETT COMPANY, INC.]4
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8PROBENECID TABLET, FILM COATED [LANNETT COMPANY, INC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PROBENECID TABLET, FILM COATED [LANNETT COMPANY, INC.]4
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1APROBENECID TABLET, FILM COATED [LANNETT COMPANY, INC.]4
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990PROBENECID TABLET, FILM COATED [LANNETT COMPANY, INC.]4
POVIDONE K29/32INACTIVE INGREDIENT390RMW2PEQPROBENECID TABLET, FILM COATED [LANNETT COMPANY, INC.]4
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JPROBENECID TABLET, FILM COATED [LANNETT COMPANY, INC.]4
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2PROBENECID TABLET, FILM COATED [LANNETT COMPANY, INC.]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPROBENECID TABLET, FILM COATED [LANNETT COMPANY, INC.]4
TALCINACTIVE INGREDIENT7SEV7J4R1UPROBENECID TABLET, FILM COATED [LANNETT COMPANY, INC.]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPROBENECID TABLET, FILM COATED [LANNETT COMPANY, INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0527-1367PROBENECID TABLET, FILM COATED [LANNETT COMPANY, INC.]9Current NDC, Legacy NDC, 2 package rows20240704_ab497fd8-00c3-4364-b003-b39d21fbdf38.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198152probenecid 500 MG Oral TabletPSN6aec72b5-a9f4-45a3-82a6-7d3de64ba5e5100
198152probenecid 500 MG Oral TabletSCD6aec72b5-a9f4-45a3-82a6-7d3de64ba5e5100
198152probenecid 500 MG Oral TabletPSNab497fd8-00c3-4364-b003-b39d21fbdf389
198152probenecid 500 MG Oral TabletSCDab497fd8-00c3-4364-b003-b39d21fbdf389
198152probenecid 500 MG Oral TabletPSN69637b68-8ee2-49ac-9393-e17b01041ea72
198152probenecid 500 MG Oral TabletPSNab121e7d-8c54-417d-a657-a8b82741b9b02
198152probenecid 500 MG Oral TabletSCD69637b68-8ee2-49ac-9393-e17b01041ea72
198152probenecid 500 MG Oral TabletSCDab121e7d-8c54-417d-a657-a8b82741b9b02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0527-1367-0100527136701100 TABLET, FILM COATED in 1 BOTTLE (0527-1367-01) 1976-07-290000-00-00NoNoCurrent
0527-1367-10005271367101000 TABLET, FILM COATED in 1 BOTTLE (0527-1367-10) 1976-07-290000-00-00NoNoCurrent