Home NDC 0591-5347-00 Probenecid
Product NDC 0591-5347
Requested package NDC 0591-5347-00
11-digit product format 005915347
Labeler code 0591
Product ID 0591-5347_8319745d-3201-48c6-b1eb-9ff32e930872
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Probenecid
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Actavis Pharma, Inc.
Application ANDA084442
Marketing category ANDA
Marketing start 1983-07-01
Substance PROBENECID
Active strength 500 mg/1
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 21 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 21:27 UTC · source 2025-12-05 a6255e0c9aa5…a0211a219f2e…2025-08-26 23:59 UTC · source 2025-08-26 1d862106b807…00c93037cd84…2025-05-15 14:59 UTC · source 2025-05-14 390b4c401c3f…2c692c2daee3…2025-04-01 07:37 UTC · source 2025-03-31 e30019b0c005…a3f0b14938b7…2025-03-01 13:19 UTC · source 2025-02-28 bbbc9f937eca…946b9c97cf81…2025-02-27 05:24 UTC · source 2025-02-26 f268b84574a6…26285f5ac5df…2025-02-01 13:13 UTC · source 2025-01-31 f764e8902f78…92046438deef…2025-01-20 13:05 UTC · source 2025-01-17 68b1e3bced9e…98a755eb8bc6…2024-11-29 20:42 UTC · source 2024-11-29 05c55d027831…ca05dca9dc4c…2024-11-09 02:36 UTC · source 2024-11-08 48b4f40e6753…c7c7a00d2afa…2024-10-09 02:27 UTC · source 2024-10-08 27f29a85d7e4…1372111e901f…2024-07-10 04:00 UTC · source 2024-07-09 8d62ce987f31…9fe9ef23e30d…2024-05-28 21:11 UTC · source 2024-05-28 d1e113ab4d42…063ee3eb0a1d…2024-05-15 03:51 UTC · source 2024-05-14 50b4072663b7…eae3003ed65e…2022-04-09 23:13 UTC · source 2022-04-08 906f6e251498…bf70b80e44f0…2021-12-27 23:28 UTC · source 2021-12-27 6db9cb8d1e19…3449e1ec5b70…2021-02-18 23:40 UTC · source 2021-02-18 8fc7167e32ce…e96bbc724034…2020-12-18 03:04 UTC · source 2020-12-17 4184dd79f89f…545327b3e20f…2020-06-10 20:45 UTC · source 2020-06-10 4bd3596a7b87…5c64c6f6865f…2019-12-08 06:16 UTC · source 2019-12-05 263afe128892…91768de4ddbe…2019-06-01 22:24 UTC · source 2019-05-30 5b2001dcd8f5…54b53d4dc9e4…
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 A084442-004 PROBENECID PROBENECID 500MG TABLET / ORAL AB RS 1983-03-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A084442-004 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.
Product history page 1 of 2 · 41 observed 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 A084442-004 PROBENECID 500MG TABLET / ORAL AB RS 1983-03-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A084442-004 PROBENECID 500MG TABLET / ORAL AB RS 1983-03-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A084442-004 PROBENECID 500MG TABLET / ORAL AB RS 1983-03-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A084442-004 PROBENECID 500MG TABLET / ORAL AB RS 1983-03-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A084442-004 PROBENECID 500MG TABLET / ORAL AB RS 1983-03-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A084442-004 PROBENECID 500MG TABLET / ORAL AB RS 1983-03-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A084442-004 PROBENECID 500MG TABLET / ORAL AB RS 1983-03-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A084442-004 PROBENECID 500MG TABLET / ORAL AB RS 1983-03-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A084442-004 PROBENECID 500MG TABLET / ORAL AB RS 1983-03-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A084442-004 PROBENECID 500MG TABLET / ORAL AB RS 1983-03-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A084442-004 PROBENECID 500MG TABLET / ORAL AB RS 1983-03-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A084442-004 PROBENECID 500MG TABLET / ORAL AB RS 1983-03-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A084442-004 PROBENECID 500MG TABLET / ORAL AB RS 1983-03-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A084442-004 PROBENECID 500MG TABLET / ORAL AB RS 1983-03-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A084442-004 PROBENECID 500MG TABLET / ORAL AB RS 1983-03-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A084442-004 PROBENECID 500MG TABLET / ORAL AB RS 1983-03-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A084442-004 PROBENECID 500MG TABLET / ORAL AB RS 1983-03-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A084442-004 PROBENECID 500MG TABLET / ORAL RS 1983-03-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A084442-004 PROBENECID 500MG TABLET / ORAL AB RS 1983-03-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A084442-004 PROBENECID 500MG TABLET / ORAL AB RS 1983-03-29 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A084442-004 PROBENECID 500MG TABLET / ORAL RS 1983-03-29 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A084442-004 PROBENECID 500MG TABLET / ORAL RS 1983-03-29 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A084442-004 PROBENECID 500MG TABLET / ORAL RS 1983-03-29 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A084442-004 PROBENECID 500MG TABLET / ORAL RS 1983-03-29 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A084442-004 PROBENECID 500MG TABLET / ORAL RS 1983-03-29 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A084442-004 PROBENECID 500MG TABLET / ORAL AB 1983-03-29 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A084442-004 PROBENECID 500MG TABLET / ORAL AB 1983-03-29 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A084442-004 PROBENECID 500MG TABLET / ORAL AB RS 1983-03-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A084442-004 PROBENECID 500MG TABLET / ORAL AB RS 1983-03-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A084442-004 PROBENECID 500MG TABLET / ORAL AB RS 1983-03-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A084442-004 PROBENECID 500MG TABLET / ORAL AB RS 1983-03-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A084442-004 PROBENECID 500MG TABLET / ORAL AB RS 1983-03-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A084442-004 PROBENECID 500MG TABLET / ORAL AB RS 1983-03-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A084442-004 PROBENECID 500MG TABLET / ORAL AB RS 1983-03-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A084442-004 PROBENECID 500MG TABLET / ORAL AB RS 1983-03-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A084442-004 PROBENECID 500MG TABLET / ORAL AB RS 1983-03-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A084442-004 PROBENECID 500MG TABLET / ORAL AB RS 1983-03-29 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A084442-004 PROBENECID 500MG TABLET / ORAL AB RS 1983-03-29 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A084442-004 PROBENECID 500MG TABLET / ORAL AB RS 1983-03-29 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A084442-004 PROBENECID 500MG TABLET / ORAL AB RS 1983-03-29 cb3db0bc1861…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Probenecid
Listing expiration 2026-12-31 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 0591-5347-01 Probenecid 100 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 100 13 0591-5347-10 Probenecid 1000 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 1000 13
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded PROBENECID ACTIVE INGREDIENT PO572Z7917 PROBENECID TABLET, FILM COATED [WATSON LABORATORIES, INC.] 4 PROBENECID ACTIVE MOIETY PO572Z7917 PROBENECID TABLET, FILM COATED [WATSON LABORATORIES, INC.] 4 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U PROBENECID TABLET, FILM COATED [WATSON LABORATORIES, INC.] 4 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G PROBENECID TABLET, FILM COATED [WATSON LABORATORIES, INC.] 4 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD PROBENECID TABLET, FILM COATED [WATSON LABORATORIES, INC.] 4 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 PROBENECID TABLET, FILM COATED [WATSON LABORATORIES, INC.] 4 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO PROBENECID TABLET, FILM COATED [WATSON LABORATORIES, INC.] 4 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 PROBENECID TABLET, FILM COATED [WATSON LABORATORIES, INC.] 4 POLYETHYLENE GLYCOL INACTIVE INGREDIENT 3WJQ0SDW1A PROBENECID TABLET, FILM COATED [WATSON LABORATORIES, INC.] 4 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H PROBENECID TABLET, FILM COATED [WATSON LABORATORIES, INC.] 4 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 PROBENECID TABLET, FILM COATED [WATSON LABORATORIES, INC.] 4 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J PROBENECID TABLET, FILM COATED [WATSON LABORATORIES, INC.] 4 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 PROBENECID TABLET, FILM COATED [WATSON LABORATORIES, INC.] 4 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP PROBENECID TABLET, FILM COATED [WATSON LABORATORIES, INC.] 4 PROBENECID ACTIVE INGREDIENT PO572Z7917 PROBENECID TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 3 PROBENECID ACTIVE MOIETY PO572Z7917 PROBENECID TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 3 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U PROBENECID TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 3 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G PROBENECID TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 3 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD PROBENECID TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 3 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 PROBENECID TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 3 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO PROBENECID TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 PROBENECID TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 3 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A PROBENECID TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 3 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H PROBENECID TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 3 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 PROBENECID TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 3 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J PROBENECID TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 3 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 PROBENECID TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 3 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP PROBENECID TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 3 Probenecid ACTIVE INGREDIENT PO572Z7917 PROBENECID TABLET, FILM COATED [HHS/PROGRAM SUPPORT CENTER/SUPPLY SERVICE CENTER] 1 Probenecid ACTIVE MOIETY PO572Z7917 PROBENECID TABLET, FILM COATED [HHS/PROGRAM SUPPORT CENTER/SUPPLY SERVICE CENTER] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U PROBENECID TABLET, FILM COATED [HHS/PROGRAM SUPPORT CENTER/SUPPLY SERVICE CENTER] 1 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G PROBENECID TABLET, FILM COATED [HHS/PROGRAM SUPPORT CENTER/SUPPLY SERVICE CENTER] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD PROBENECID TABLET, FILM COATED [HHS/PROGRAM SUPPORT CENTER/SUPPLY SERVICE CENTER] 1 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 PROBENECID TABLET, FILM COATED [HHS/PROGRAM SUPPORT CENTER/SUPPLY SERVICE CENTER] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO PROBENECID TABLET, FILM COATED [HHS/PROGRAM SUPPORT CENTER/SUPPLY SERVICE CENTER] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 PROBENECID TABLET, FILM COATED [HHS/PROGRAM SUPPORT CENTER/SUPPLY SERVICE CENTER] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A PROBENECID TABLET, FILM COATED [HHS/PROGRAM SUPPORT CENTER/SUPPLY SERVICE CENTER] 1 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H PROBENECID TABLET, FILM COATED [HHS/PROGRAM SUPPORT CENTER/SUPPLY SERVICE CENTER] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 PROBENECID TABLET, FILM COATED [HHS/PROGRAM SUPPORT CENTER/SUPPLY SERVICE CENTER] 1 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J PROBENECID TABLET, FILM COATED [HHS/PROGRAM SUPPORT CENTER/SUPPLY SERVICE CENTER] 1 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 PROBENECID TABLET, FILM COATED [HHS/PROGRAM SUPPORT CENTER/SUPPLY SERVICE CENTER] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP PROBENECID TABLET, FILM COATED [HHS/PROGRAM SUPPORT CENTER/SUPPLY SERVICE CENTER] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0591-5347 PROBENECID TABLET, FILM COATED [ACTAVIS PHARMA, INC.] 13 Current NDC, Legacy NDC, 2 package rows 20250509_ae126418-5474-4fbe-b83c-bde8b2b4ae6e.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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Status 0591-5347-00 00591534700 14000 TABLET, FILM COATED in 1 BAG (0591-5347-00) 01-JUL-83 Current