Home NDC 10135-541 Probenecid
Product NDC 10135-541
11-digit product format 101350541
Labeler code 10135
Product ID 10135-541_43e0b999-0f40-3c9d-e063-6294a90ae477
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Probenecid
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Marlex Pharmaceuticals Inc
Application ANDA080966
Marketing category ANDA
Marketing start 1976-07-29
Substance PROBENECID
Active strength 500 mg/1
NDC exclude flag No
Listing certified through 2026-12-31
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 A080966-001 PROBALAN PROBENECID 500MG TABLET / ORAL AB Approved before 1982
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A080966-001 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.
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 A080966-001 PROBALAN 500MG TABLET / ORAL AB Approved before 1982 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A080966-001 PROBALAN 500MG TABLET / ORAL AB Approved before 1982 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A080966-001 PROBALAN 500MG TABLET / ORAL AB Approved before 1982 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A080966-001 PROBALAN 500MG TABLET / ORAL AB Approved before 1982 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A080966-001 PROBALAN 500MG TABLET / ORAL AB Approved before 1982 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A080966-001 PROBALAN 500MG TABLET / ORAL AB Approved before 1982 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A080966-001 PROBALAN 500MG TABLET / ORAL AB Approved before 1982 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A080966-001 PROBALAN 500MG TABLET / ORAL AB Approved before 1982 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A080966-001 PROBALAN 500MG TABLET / ORAL AB Approved before 1982 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A080966-001 PROBALAN 500MG TABLET / ORAL AB Approved before 1982 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A080966-001 PROBALAN 500MG TABLET / ORAL AB Approved before 1982 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A080966-001 PROBALAN 500MG TABLET / ORAL AB Approved before 1982 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A080966-001 PROBALAN 500MG TABLET / ORAL AB Approved before 1982 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A080966-001 PROBALAN 500MG TABLET / ORAL AB Approved before 1982 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A080966-001 PROBALAN 500MG TABLET / ORAL AB Approved before 1982 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A080966-001 PROBALAN 500MG TABLET / ORAL AB Approved before 1982 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A080966-001 PROBALAN 500MG TABLET / ORAL AB Approved before 1982 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A080966-001 PROBALAN 500MG TABLET / ORAL AB Approved before 1982 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A080966-001 PROBALAN 500MG TABLET / ORAL AB Approved before 1982 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A080966-001 PROBALAN 500MG TABLET / ORAL AB Approved before 1982 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A080966-001 PROBALAN 500MG TABLET / ORAL AB Approved before 1982 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A080966-001 PROBALAN 500MG TABLET / ORAL AB Approved before 1982 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A080966-001 PROBALAN 500MG TABLET / ORAL AB Approved before 1982 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A080966-001 PROBALAN 500MG TABLET / ORAL AB Approved before 1982 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A080966-001 PROBALAN 500MG TABLET / ORAL AB Approved before 1982 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A080966-001 PROBALAN 500MG TABLET / ORAL AB Approved before 1982 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A080966-001 PROBALAN 500MG TABLET / ORAL AB Approved before 1982 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A080966-001 PROBALAN 500MG TABLET / ORAL AB Approved before 1982 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A080966-001 PROBALAN 500MG TABLET / ORAL AB Approved before 1982 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A080966-001 PROBALAN 500MG TABLET / ORAL AB Approved before 1982 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A080966-001 PROBALAN 500MG TABLET / ORAL AB Approved before 1982 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A080966-001 PROBALAN 500MG TABLET / ORAL AB Approved before 1982 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A080966-001 PROBALAN 500MG TABLET / ORAL AB Approved before 1982 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A080966-001 PROBALAN 500MG TABLET / ORAL AB Approved before 1982 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A080966-001 PROBALAN 500MG TABLET / ORAL AB Approved before 1982 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A080966-001 PROBALAN 500MG TABLET / ORAL AB Approved before 1982 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A080966-001 PROBALAN 500MG TABLET / ORAL AB Approved before 1982 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A080966-001 PROBALAN 500MG TABLET / ORAL AB Approved before 1982 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A080966-001 PROBALAN 500MG TABLET / ORAL AB Approved before 1982 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A080966-001 PROBALAN 500MG TABLET / ORAL AB Approved before 1982 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 10135-541-01 Probenecid 100 in 1 BOTTLE TABLET, FILM COATED 100 11 10135-541-10 Probenecid 1000 in 1 BOTTLE TABLET, FILM COATED 1000 11
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded PROBENECID ACTIVE INGREDIENT PO572Z7917 PROBENECID TABLET, FILM COATED [MARLEX PHARMACEUTICALS INC] 2 PROBENECID ACTIVE MOIETY PO572Z7917 PROBENECID TABLET, FILM COATED [MARLEX PHARMACEUTICALS INC] 2 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 PROBENECID TABLET, FILM COATED [MARLEX PHARMACEUTICALS INC] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U PROBENECID TABLET, FILM COATED [MARLEX PHARMACEUTICALS INC] 2 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G PROBENECID TABLET, FILM COATED [MARLEX PHARMACEUTICALS INC] 2 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK PROBENECID TABLET, FILM COATED [MARLEX PHARMACEUTICALS INC] 2 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 PROBENECID TABLET, FILM COATED [MARLEX PHARMACEUTICALS INC] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 PROBENECID TABLET, FILM COATED [MARLEX PHARMACEUTICALS INC] 2 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A PROBENECID TABLET, FILM COATED [MARLEX PHARMACEUTICALS INC] 2 POLYVINYL ALCOHOL INACTIVE INGREDIENT 532B59J990 PROBENECID TABLET, FILM COATED [MARLEX PHARMACEUTICALS INC] 2 POVIDONE K29/32 INACTIVE INGREDIENT 390RMW2PEQ PROBENECID TABLET, FILM COATED [MARLEX PHARMACEUTICALS INC] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 PROBENECID TABLET, FILM COATED [MARLEX PHARMACEUTICALS INC] 2 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J PROBENECID TABLET, FILM COATED [MARLEX PHARMACEUTICALS INC] 2 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 PROBENECID TABLET, FILM COATED [MARLEX PHARMACEUTICALS INC] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ PROBENECID TABLET, FILM COATED [MARLEX PHARMACEUTICALS INC] 2 TALC INACTIVE INGREDIENT 7SEV7J4R1U PROBENECID TABLET, FILM COATED [MARLEX PHARMACEUTICALS INC] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP PROBENECID TABLET, FILM COATED [MARLEX PHARMACEUTICALS INC] 2 PROBENECID ACTIVE INGREDIENT PO572Z7917 PROBENECID TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 PROBENECID ACTIVE MOIETY PO572Z7917 PROBENECID TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 PROBENECID TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U PROBENECID TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G PROBENECID TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK PROBENECID TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 PROBENECID TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 PROBENECID TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A PROBENECID TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 POLYVINYL ALCOHOL INACTIVE INGREDIENT 532B59J990 PROBENECID TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 POVIDONE K29/32 INACTIVE INGREDIENT 390RMW2PEQ PROBENECID TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 PROBENECID TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J PROBENECID TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 PROBENECID TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ PROBENECID TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U PROBENECID TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP PROBENECID TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 10135-541 PROBENECID TABLET, FILM COATED [MARLEX PHARMACEUTICALS INC] 10 Current NDC, Legacy NDC, 2 package rows 20241018_5d552de5-2d18-4464-bcaf-0311fa3f080d.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 Marketing start Marketing end Sample Exclude flag Status 10135-541-01 10135054101 100 TABLET, FILM COATED in 1 BOTTLE (10135-541-01) 1976-07-29 0000-00-00 No No Current 10135-541-10 10135054110 1000 TABLET, FILM COATED in 1 BOTTLE (10135-541-10) 1976-07-29 0000-00-00 No No Current