Home NDC 50458-675 VERMOX
Product NDC 50458-675
11-digit product format 504580675
Labeler code 50458
Product ID 50458-675_5757cf97-389e-4199-8b53-d32a18e55800
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name mebendazole
Dosage form TABLET, CHEWABLE
Route ORAL
Labeler Janssen Pharmaceuticals, Inc.
Application NDA208398
Marketing category NDA
Marketing start 2016-10-20
Substance MEBENDAZOLE
Active strength 500 mg/1
Pharmacologic classes Anthelmintic [EPC]
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 N208398-001 VERMOX MEBENDAZOLE 500MG TABLET, CHEWABLE / ORAL RLD 2016-10-19
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 N208398-001 VERMOX 500MG TABLET, CHEWABLE / ORAL RLD 2016-10-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208398-001 VERMOX 500MG TABLET, CHEWABLE / ORAL RLD 2016-10-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N208398-001 VERMOX 500MG TABLET, CHEWABLE / ORAL RLD 2016-10-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208398-001 VERMOX 500MG TABLET, CHEWABLE / ORAL RLD 2016-10-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208398-001 VERMOX 500MG TABLET, CHEWABLE / ORAL RLD 2016-10-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208398-001 VERMOX 500MG TABLET, CHEWABLE / ORAL RLD 2016-10-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208398-001 VERMOX 500MG TABLET, CHEWABLE / ORAL RLD 2016-10-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208398-001 VERMOX 500MG TABLET, CHEWABLE / ORAL RLD 2016-10-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208398-001 VERMOX 500MG TABLET, CHEWABLE / ORAL RLD 2016-10-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N208398-001 VERMOX 500MG TABLET, CHEWABLE / ORAL RLD 2016-10-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N208398-001 VERMOX 500MG TABLET, CHEWABLE / ORAL RLD 2016-10-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N208398-001 VERMOX 500MG TABLET, CHEWABLE / ORAL RLD 2016-10-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N208398-001 VERMOX 500MG TABLET, CHEWABLE / ORAL RLD 2016-10-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N208398-001 VERMOX 500MG TABLET, CHEWABLE / ORAL RLD 2016-10-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N208398-001 VERMOX 500MG TABLET, CHEWABLE / ORAL RLD 2016-10-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N208398-001 VERMOX 500MG TABLET, CHEWABLE / ORAL RLD 2016-10-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N208398-001 VERMOX 500MG TABLET, CHEWABLE / ORAL RLD 2016-10-19 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N208398-001 VERMOX 500MG TABLET, CHEWABLE / ORAL RLD 2016-10-19 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N208398-001 VERMOX 500MG TABLET, CHEWABLE / ORAL RLD 2016-10-19 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N208398-001 VERMOX 500MG TABLET, CHEWABLE / ORAL RLD 2016-10-19 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N208398-001 VERMOX 500MG TABLET, CHEWABLE / ORAL RLD 2016-10-19 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N208398-001 VERMOX 500MG TABLET, CHEWABLE / ORAL RLD 2016-10-19 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N208398-001 VERMOX 500MG TABLET, CHEWABLE / ORAL RLD 2016-10-19 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N208398-001 VERMOX 500MG TABLET, CHEWABLE / ORAL RLD 2016-10-19 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N208398-001 VERMOX 500MG TABLET, CHEWABLE / ORAL RLD 2016-10-19 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N208398-001 VERMOX 500MG TABLET, CHEWABLE / ORAL RLD 2016-10-19 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N208398-001 VERMOX 500MG TABLET, CHEWABLE / ORAL RLD 2016-10-19 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N208398-001 VERMOX 500MG TABLET, CHEWABLE / ORAL RLD 2016-10-19 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N208398-001 VERMOX 500MG TABLET, CHEWABLE / ORAL RLD 2016-10-19 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N208398-001 VERMOX 500MG TABLET, CHEWABLE / ORAL RLD 2016-10-19 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N208398-001 VERMOX 500MG TABLET, CHEWABLE / ORAL RLD 2016-10-19 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N208398-001 VERMOX 500MG TABLET, CHEWABLE / ORAL RLD 2016-10-19 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N208398-001 VERMOX 500MG TABLET, CHEWABLE / ORAL RLD 2016-10-19 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N208398-001 VERMOX 500MG TABLET, CHEWABLE / ORAL RLD 2016-10-19 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N208398-001 VERMOX 500MG TABLET, CHEWABLE / ORAL RLD 2016-10-19 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N208398-001 VERMOX 500MG TABLET, CHEWABLE / ORAL RLD 2016-10-19 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N208398-001 VERMOX 500MG TABLET, CHEWABLE / ORAL RLD 2016-10-19 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N208398-001 VERMOX 500MG TABLET, CHEWABLE / ORAL RLD 2016-10-19 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N208398-001 VERMOX 500MG TABLET, CHEWABLE / ORAL RLD 2016-10-19 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N208398-001 VERMOX 500MG TABLET, CHEWABLE / ORAL RLD 2016-10-19 cb3db0bc1861…
Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2019-12-13 00:20 UTC 2019-12 N208398-001 NS 2019-10-19 74a2ff9319b5…2019-12-14 00:12 UTC 2019-12 N208398-001 NS 2019-10-19 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N208398-001 NS 2019-10-19 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N208398-001 NS 2019-10-19 ea99ee380514…
Additional Listing Data#
Finished product Yes
Brand name base VERMOX
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MEBENDAZOLE 500 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 81G6I5V05I Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1855385 Internal RxNorm lookup 1855387 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 50458-675-20 VERMOX 200 in 1 BOTTLE TABLET, CHEWABLE 200 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50458-675 VERMOX (MEBENDAZOLE) TABLET, CHEWABLE [JANSSEN PHARMACEUTICALS, INC.] 5 Current NDC, Legacy NDC, 1 package rows 20211006_a720c424-517a-461b-8e13-6c37caf8aa3f.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 Marketing end Sample Exclude flag Status 50458-675-20 50458067520 200 TABLET, CHEWABLE in 1 BOTTLE (50458-675-20) 2016-10-20 0000-00-00 No No Current