Home NDC 72603-246 Zileuton
Product NDC 72603-246
11-digit product format 726030246
Labeler code 72603
Product ID 72603-246_17766300-70b8-ee56-e063-6294a90aeb1a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Zileuton
Dosage form TABLET, FILM COATED, EXTENDED RELEASE
Route ORAL
Labeler NorthStar RxLLC
Application ANDA215742
Marketing category ANDA
Marketing start 2024-05-01
Substance ZILEUTON
Active strength 600 mg/1
Pharmacologic classes 5-Lipoxygenase Inhibitor [EPC], 5-Lipoxygenase Inhibitors [MoA], Decreased Leukotriene Production [PE]
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 42 .
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 A215742-001 ZILEUTON ZILEUTON 600MG TABLET, EXTENDED RELEASE / ORAL AB 2022-10-11
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A215742-001 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 2026-08-18 06:07:40 2026-07 A215742-001 ZILEUTON 600MG TABLET, EXTENDED RELEASE / ORAL AB 2022-10-11 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A215742-001 ZILEUTON 600MG TABLET, EXTENDED RELEASE / ORAL AB 2022-10-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215742-001 ZILEUTON 600MG TABLET, EXTENDED RELEASE / ORAL AB 2022-10-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215742-001 ZILEUTON 600MG TABLET, EXTENDED RELEASE / ORAL AB 2022-10-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215742-001 ZILEUTON 600MG TABLET, EXTENDED RELEASE / ORAL AB 2022-10-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215742-001 ZILEUTON 600MG TABLET, EXTENDED RELEASE / ORAL AB 2022-10-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215742-001 ZILEUTON 600MG TABLET, EXTENDED RELEASE / ORAL AB 2022-10-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215742-001 ZILEUTON 600MG TABLET, EXTENDED RELEASE / ORAL AB 2022-10-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215742-001 ZILEUTON 600MG TABLET, EXTENDED RELEASE / ORAL AB 2022-10-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215742-001 ZILEUTON 600MG TABLET, EXTENDED RELEASE / ORAL AB 2022-10-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A215742-001 ZILEUTON 600MG TABLET, EXTENDED RELEASE / ORAL AB 2022-10-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215742-001 ZILEUTON 600MG TABLET, EXTENDED RELEASE / ORAL AB 2022-10-11 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215742-001 ZILEUTON 600MG TABLET, EXTENDED RELEASE / ORAL AB 2022-10-11 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215742-001 ZILEUTON 600MG TABLET, EXTENDED RELEASE / ORAL AB 2022-10-11 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A215742-001 ZILEUTON 600MG TABLET, EXTENDED RELEASE / ORAL AB 2022-10-11 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A215742-001 ZILEUTON 600MG TABLET, EXTENDED RELEASE / ORAL AB 2022-10-11 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A215742-001 ZILEUTON 600MG TABLET, EXTENDED RELEASE / ORAL AB 2022-10-11 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A215742-001 ZILEUTON 600MG TABLET, EXTENDED RELEASE / ORAL AB 2022-10-11 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A215742-001 ZILEUTON 600MG TABLET, EXTENDED RELEASE / ORAL AB 2022-10-11 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A215742-001 ZILEUTON 600MG TABLET, EXTENDED RELEASE / ORAL AB 2022-10-11 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A215742-001 ZILEUTON 600MG TABLET, EXTENDED RELEASE / ORAL AB 2022-10-11 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A215742-001 ZILEUTON 600MG TABLET, EXTENDED RELEASE / ORAL AB 2022-10-11 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A215742-001 ZILEUTON 600MG TABLET, EXTENDED RELEASE / ORAL AB 2022-10-11 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A215742-001 ZILEUTON 600MG TABLET, EXTENDED RELEASE / ORAL AB 2022-10-11 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A215742-001 ZILEUTON 600MG TABLET, EXTENDED RELEASE / ORAL AB 2022-10-11 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A215742-001 ZILEUTON 600MG TABLET, EXTENDED RELEASE / ORAL AB 2022-10-11 f41ea6bd6efb…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215742-001 ZILEUTON 600MG TABLET, EXTENDED RELEASE / ORAL AB 2022-10-11 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Zileuton
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZILEUTON 600 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination V1L22WVE2S Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 730834 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 72603-246-01 Zileuton 120 in 1 BOTTLE TABLET, FILM COATED, EXTENDED RE 120 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72603-246 ZILEUTON (ZILEUTON) TABLET, FILM COATED, EXTENDED RELEASE [NORTHSTAR RXLLC] 1 Current NDC, 1 package rows 20240503_bc29c998-1324-46aa-8386-e5b2fc9e0b16.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 72603-246-01 72603024601 120 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (72603-246-01) 2024-05-01 No No Current