Home NDC 70518-4644 Probenecid and Colchicine
Product NDC 70518-4644
11-digit product format 705184644
Labeler code 70518
Product ID 70518-4644_5089d41d-851c-5a13-e063-6394a90a5e38
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Probenecid and Colchicine
Dosage form TABLET
Route ORAL
Labeler REMEDYREPACK INC.
Application ANDA217030
Marketing category ANDA
Marketing start 2026-04-28
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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A217030-001 PROBENECID AND COLCHICINE COLCHICINE; PROBENECID 0.5MG;500MG TABLET / ORAL AB 2023-10-24
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A217030-001 AB
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A217030-001 PROBENECID AND COLCHICINE 0.5MG;500MG TABLET / ORAL AB 2023-10-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217030-001 PROBENECID AND COLCHICINE 0.5MG;500MG TABLET / ORAL AB 2023-10-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217030-001 PROBENECID AND COLCHICINE 0.5MG;500MG TABLET / ORAL AB 2023-10-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217030-001 PROBENECID AND COLCHICINE 0.5MG;500MG TABLET / ORAL AB 2023-10-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217030-001 PROBENECID AND COLCHICINE 0.5MG;500MG TABLET / ORAL AB 2023-10-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217030-001 PROBENECID AND COLCHICINE 0.5MG;500MG TABLET / ORAL AB 2023-10-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217030-001 PROBENECID AND COLCHICINE 0.5MG;500MG TABLET / ORAL AB 2023-10-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217030-001 PROBENECID AND COLCHICINE 0.5MG;500MG TABLET / ORAL AB 2023-10-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217030-001 PROBENECID AND COLCHICINE 0.5MG;500MG TABLET / ORAL AB 2023-10-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A217030-001 PROBENECID AND COLCHICINE 0.5MG;500MG TABLET / ORAL AB 2023-10-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217030-001 PROBENECID AND COLCHICINE 0.5MG;500MG TABLET / ORAL AB 2023-10-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A217030-001 PROBENECID AND COLCHICINE 0.5MG;500MG TABLET / ORAL AB 2023-10-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A217030-001 PROBENECID AND COLCHICINE 0.5MG;500MG TABLET / ORAL AB 2023-10-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A217030-001 PROBENECID AND COLCHICINE 0.5MG;500MG TABLET / ORAL AB 2023-10-24 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A217030-001 PROBENECID AND COLCHICINE 0.5MG;500MG TABLET / ORAL AB 2023-10-24 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A217030-001 PROBENECID AND COLCHICINE 0.5MG;500MG TABLET / ORAL AB 2023-10-24 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A217030-001 PROBENECID AND COLCHICINE 0.5MG;500MG TABLET / ORAL AB 2023-10-24 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A217030-001 PROBENECID AND COLCHICINE 0.5MG;500MG TABLET / ORAL AB 2023-10-24 a72a2bbeb626…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217030-001 PROBENECID AND COLCHICINE 0.5MG;500MG TABLET / ORAL AB 2023-10-24 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Probenecid and Colchicine
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PROBENECID .5 mg/1 COLCHICINE 500 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination PO572Z7917 Internal UNII lookup SML2Y3J35T Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198153 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 70518-4644-0 Probenecid and Colchicine 50 in 1 BOX TABLET 50 1 70518-4644-1 Probenecid and Colchicine 1 in 1 POUCH TABLET 1 1
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 70518-4644-0 70518464400 50 POUCH in 1 BOX (70518-4644-0) / 1 TABLET in 1 POUCH (70518-4644-1) 50 pouch 2026-04-28 No No Current 70518-4644-1 70518464401 1 in 1 POUCH Historical