FDA.reportPublic FDA data

Probenecid and Colchicine

Product NDC
0591-5325
11-digit product format
005915325
Labeler code
0591
Product ID
0591-5325_08577252-5289-46f0-80b4-06442a22b332
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Probenecid and Colchicine
Dosage form
TABLET
Route
ORAL
Labeler
Actavis Pharma, Inc.
Application
ANDA084279
Marketing category
ANDA
Marketing start
1982-10-01
Substance
COLCHICINE; PROBENECID
Active strength
.5; 500 mg/1; mg/1
Pharmacologic classes
Alkaloid [EPC], Alkaloids [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
COLCHICINE.5 mg/1
PROBENECID500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiSML2Y3J35T, PO572Z7917
Rxcui198153

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e312405-bfef-73b2-fc56-fea2b3b68305Product name220250731
51989a2b-944a-b31f-835e-469c133570adProduct name220250716
11e940b0-77bd-45d4-a80f-028ff6bd67e2Product name220250214
14efe2b0-2695-4943-8b2f-24f519c99fedProduct name120231023
bf4e8ffd-8f13-3050-5248-581676b7ea42Product name620221214
987af351-b977-4822-ac44-c76d29e24e78Product name120190611

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0591-5325-01Probenecid and Colchicine100 in 1 BOTTLE, PLASTICTABLET1007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0591-5325-01EA - Each0591-532521727934-fa7b-444f-b5f8-443053e4073e12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
COLCHICINEACTIVE INGREDIENTSML2Y3J35TPROBENECID AND COLCHICINE TABLET [WATSON LABORATORIES, INC.]2
PROBENECIDACTIVE INGREDIENTPO572Z7917PROBENECID AND COLCHICINE TABLET [WATSON LABORATORIES, INC.]2
COLCHICINEACTIVE MOIETYSML2Y3J35TPROBENECID AND COLCHICINE TABLET [WATSON LABORATORIES, INC.]2
PROBENECIDACTIVE MOIETYPO572Z7917PROBENECID AND COLCHICINE TABLET [WATSON LABORATORIES, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPROBENECID AND COLCHICINE TABLET [WATSON LABORATORIES, INC.]2
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PROBENECID AND COLCHICINE TABLET [WATSON LABORATORIES, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PROBENECID AND COLCHICINE TABLET [WATSON LABORATORIES, INC.]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JPROBENECID AND COLCHICINE TABLET [WATSON LABORATORIES, INC.]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2PROBENECID AND COLCHICINE TABLET [WATSON LABORATORIES, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0591-5325PROBENECID AND COLCHICINE TABLET [ACTAVIS PHARMA, INC.]7Current NDC, Legacy NDC, 1 package rows20240302_a0567fe6-132b-463b-bc46-9f5a2a2478fb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198153probenecid 500 MG / colchicine 0.5 MG Oral TabletPSNa0567fe6-132b-463b-bc46-9f5a2a2478fb7
198153colchicine 0.5 MG / probenecid 500 MG Oral TabletSCDa0567fe6-132b-463b-bc46-9f5a2a2478fb7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0591-5325-000059153250014000 TABLET in 1 BAG (0591-5325-00)14000 tablet01-OCT-82Current
0591-5325-0100591532501100 TABLET in 1 BOTTLE, PLASTIC (0591-5325-01) 100 tablet1982-10-010000-00-00NoNoCurrent
0591-5325-770059153257717148 TABLET in 1 CONTAINER (0591-5325-77)17148 tablet16-SEP-24Current