Home NDC 16571-831 Probenecid
Product NDC 16571-831
11-digit product format 165710831
Labeler code 16571
Product ID 16571-831_5b9e2e37-77b7-464f-9bc8-ff678643d773
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Probenecid
Dosage form TABLET
Route ORAL
Labeler Rising Pharma Holdings, Inc.
Application ANDA217020
Marketing category ANDA
Marketing start 2023-11-20
Substance PROBENECID
Active strength 500 mg/1
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 A217020-001 PROBENECID PROBENECID 500MG TABLET / ORAL AB 2023-11-20
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A217020-001 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 A217020-001 PROBENECID 500MG TABLET / ORAL AB 2023-11-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217020-001 PROBENECID 500MG TABLET / ORAL AB 2023-11-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217020-001 PROBENECID 500MG TABLET / ORAL AB 2023-11-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217020-001 PROBENECID 500MG TABLET / ORAL AB 2023-11-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217020-001 PROBENECID 500MG TABLET / ORAL AB 2023-11-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217020-001 PROBENECID 500MG TABLET / ORAL AB 2023-11-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217020-001 PROBENECID 500MG TABLET / ORAL AB 2023-11-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217020-001 PROBENECID 500MG TABLET / ORAL AB 2023-11-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217020-001 PROBENECID 500MG TABLET / ORAL AB 2023-11-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A217020-001 PROBENECID 500MG TABLET / ORAL AB 2023-11-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217020-001 PROBENECID 500MG TABLET / ORAL AB 2023-11-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A217020-001 PROBENECID 500MG TABLET / ORAL AB 2023-11-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A217020-001 PROBENECID 500MG TABLET / ORAL AB 2023-11-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A217020-001 PROBENECID 500MG TABLET / ORAL AB 2023-11-20 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A217020-001 PROBENECID 500MG TABLET / ORAL AB 2023-11-20 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A217020-001 PROBENECID 500MG TABLET / ORAL AB 2023-11-20 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A217020-001 PROBENECID 500MG TABLET / ORAL AB 2023-11-20 ea1830bbd6c7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217020-001 PROBENECID 500MG TABLET / ORAL AB 2023-11-20 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Probenecid
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PROBENECID 500 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination PO572Z7917 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198152 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 16571-831-01 Probenecid 100 in 1 CONTAINER TABLET 100 5 16571-831-10 Probenecid 1000 in 1 CONTAINER TABLET 1000 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 16571-831 PROBENECID TABLET [RISING PHARMA HOLDINGS, INC.] 4 Current NDC, 2 package rows 20231130_f2375d90-4132-4fb6-aee7-c4f9d11e98d5.zip
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 · 3 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 16571-831-01 16571083101 100 TABLET in 1 CONTAINER (16571-831-01) 100 tablet 2023-11-20 No No Current 16571-831-10 16571083110 1000 TABLET in 1 CONTAINER (16571-831-10) 1000 tablet 2023-11-20 No No Current