FDA.reportPublic FDA data

Probenecid

Product NDC
0378-0156
11-digit product format
003780156
Labeler code
0378
Product ID
0378-0156_2688cc93-95b6-4860-aac7-d347ed9f263f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
probenecid
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA084211
Marketing category
ANDA
Marketing start
1976-01-13
Marketing end
0000-00-00
Substance
PROBENECID
Active strength
500 mg/1
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-0156-01EA - Each0378-01567f55adac-e7c5-4ad7-a4dc-79a81a82cc5e12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PROBENECIDACTIVE INGREDIENTPO572Z7917PROBENECID TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
PROBENECIDACTIVE MOIETYPO572Z7917PROBENECID TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPROBENECID TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GPROBENECID TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKPROBENECID TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8PROBENECID TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPROBENECID TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PROBENECID TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEPROBENECID TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1APROBENECID TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PROBENECID TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
SODIUM CARBONATEINACTIVE INGREDIENT45P3261C7TPROBENECID TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JPROBENECID TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2PROBENECID TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPROBENECID TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPROBENECID TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
TRIACETININACTIVE INGREDIENTXHX3C3X673PROBENECID TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198152probenecid 500 MG Oral TabletPSN8459857e-1a52-45de-81e6-e06ce18508bb2
198152probenecid 500 MG Oral TabletSCD8459857e-1a52-45de-81e6-e06ce18508bb2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0378-0156-0100378015601100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0156-01) 1976-01-130000-00-00NoNoCurrent