Probenecid and Colchicine

Product NDC
16571-832
11-digit product format
165710832
Labeler code
16571
Product ID
16571-832_64aeee43-1864-41f8-8c65-bdcfb7d12142
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Probenecid and Colchicine
Dosage form
TABLET
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA217030
Marketing category
ANDA
Marketing start
2023-10-24
Substance
COLCHICINE; PROBENECID
Active strength
.5; 500 mg/1; mg/1
Pharmacologic classes
Alkaloid [EPC], Alkaloids [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Probenecid and Colchicine
Listing expiration
2027-12-31

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
16571-832-01Probenecid and Colchicine100 in 1 CONTAINERTABLET1006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16571-832-01EA - Each16571-8325ffde0ea-0868-442a-b03d-a4d12e7d4f7812023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16571-832PROBENECID AND COLCHICINE TABLET [RISING PHARMA HOLDINGS, INC.]5Current NDC, 1 package rows20231108_3d2a3d4f-38a3-4669-ad78-ab1d7aef4ec3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198153probenecid 500 MG / colchicine 0.5 MG Oral TabletPSN3d2a3d4f-38a3-4669-ad78-ab1d7aef4ec36
198153colchicine 0.5 MG / probenecid 500 MG Oral TabletSCD3d2a3d4f-38a3-4669-ad78-ab1d7aef4ec36
198153probenecid 500 MG / colchicine 0.5 MG Oral TabletPSN573e61e5-f5e1-4119-9d8e-d9a961a1baa91
198153colchicine 0.5 MG / probenecid 500 MG Oral TabletSCD573e61e5-f5e1-4119-9d8e-d9a961a1baa91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
16571-832-0116571083201100 TABLET in 1 CONTAINER (16571-832-01) 100 tablet2023-10-24NoNoHistorical