Probenecid

Product NDC
70518-4649
11-digit product format
705184649
Labeler code
70518
Product ID
70518-4649_5098c53d-d892-0c71-e063-6394a90a9d27
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Probenecid
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA217020
Marketing category
ANDA
Marketing start
2026-04-28
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A217020-001PROBENECIDPROBENECID500MGTABLET / ORALAB2023-11-20

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A217020-001AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A217020-001PROBENECID500MGTABLET / ORALAB2023-11-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217020-001PROBENECID500MGTABLET / ORALAB2023-11-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08A217020-001PROBENECID500MGTABLET / ORALAB2023-11-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217020-001PROBENECID500MGTABLET / ORALAB2023-11-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217020-001PROBENECID500MGTABLET / ORALAB2023-11-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217020-001PROBENECID500MGTABLET / ORALAB2023-11-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217020-001PROBENECID500MGTABLET / ORALAB2023-11-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217020-001PROBENECID500MGTABLET / ORALAB2023-11-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217020-001PROBENECID500MGTABLET / ORALAB2023-11-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A217020-001PROBENECID500MGTABLET / ORALAB2023-11-20d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A217020-001PROBENECID500MGTABLET / ORALAB2023-11-2079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A217020-001PROBENECID500MGTABLET / ORALAB2023-11-20301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A217020-001PROBENECID500MGTABLET / ORALAB2023-11-201e350fbaab3a…
2024-05-31 18:47 UTC2024-05A217020-001PROBENECID500MGTABLET / ORALAB2023-11-208072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A217020-001PROBENECID500MGTABLET / ORALAB2023-11-206a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A217020-001PROBENECID500MGTABLET / ORALAB2023-11-201c564ffb4f44…
2023-12-20 04:57 UTC2023-12A217020-001PROBENECID500MGTABLET / ORALAB2023-11-20ea1830bbd6c7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217020-001PROBENECID500MGTABLET / ORALAB2023-11-20a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A217020-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217020-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A217020-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217020-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217020-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217020-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217020-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217020-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217020-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A217020-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A217020-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A217020-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A217020-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A217020-001AB18072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A217020-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A217020-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A217020-001AB1ea1830bbd6c7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217020-001AB1a50c72e98297…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PROBENECID500 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
PO572Z7917Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198152Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
65b4888c-d49a-433f-9bfd-17880ae40069Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e312405-bfef-73b2-fc56-fea2b3b68305Product name220250731
51989a2b-944a-b31f-835e-469c133570adProduct name220250716

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-4649-0Probenecid50 in 1 BOXTABLET501
70518-4649-1Probenecid1 in 1 POUCHTABLET11

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ProbenecidPROBENECIDREMEDYREPACK INC.65b4888c-d49a-433f-9bfd-17880ae400692026-04-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217020
application number: ANDA217020
ndc (product): 70518-4649
ProbenecidPROBENECIDRising Pharma Holdings, Inc.f2375d90-4132-4fb6-aee7-c4f9d11e98d52026-01-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217020
application number: ANDA217020
ProbenecidPROBENECIDBryant Ranch Prepacka4f4b3e1-44a9-4b3a-9f7f-f9749ed451ca2024-08-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217020
application number: ANDA217020

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198152probenecid 500 MG Oral TabletPSN65b4888c-d49a-433f-9bfd-17880ae400691
198152probenecid 500 MG Oral TabletSCD65b4888c-d49a-433f-9bfd-17880ae400691

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-4649-07051846490050 POUCH in 1 BOX (70518-4649-0) / 1 TABLET in 1 POUCH (70518-4649-1) 50 pouch2026-04-28NoNoCurrent
70518-4649-1705184649011 in 1 POUCHHistorical