zileuton

Generic: zileuton

Labeler: northstar rxllc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name zileuton
Generic Name zileuton
Labeler northstar rxllc
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

zileuton 600 mg/1

Manufacturer
NorthStar RxLLC

Identifiers & Regulatory

Product NDC 72603-246
Product ID 72603-246_17766300-70b8-ee56-e063-6294a90aeb1a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215742
Listing Expiration 2026-12-31
Marketing Start 2024-05-01

Pharmacologic Class

Established (EPC)
5-lipoxygenase inhibitor [epc]
Mechanism of Action
5-lipoxygenase inhibitors [moa]
Physiologic Effect
decreased leukotriene production [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72603246
Hyphenated Format 72603-246

Supplemental Identifiers

RxCUI
730834
UNII
V1L22WVE2S
NUI
N0000175956 N0000175955 N0000008683

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name zileuton (source: ndc)
Generic Name zileuton (source: ndc)
Application Number ANDA215742 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 600 mg/1
source: ndc
Packaging
  • 120 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (72603-246-01)
source: ndc

Packages (1)

72603-246-01 120 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (72603-246-01)

Ingredients (1)

zileuton (600 mg/1)

Linked Drug Pages (1)

Zileuton ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "17766300-70b8-ee56-e063-6294a90aeb1a", "openfda": {"nui": ["N0000175956", "N0000175955", "N0000008683"], "unii": ["V1L22WVE2S"], "rxcui": ["730834"], "spl_set_id": ["bc29c998-1324-46aa-8386-e5b2fc9e0b16"], "pharm_class_pe": ["Decreased Leukotriene Production [PE]"], "pharm_class_epc": ["5-Lipoxygenase Inhibitor [EPC]"], "pharm_class_moa": ["5-Lipoxygenase Inhibitors [MoA]"], "manufacturer_name": ["NorthStar RxLLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (72603-246-01)", "package_ndc": "72603-246-01", "marketing_start_date": "20240501"}], "brand_name": "Zileuton", "product_id": "72603-246_17766300-70b8-ee56-e063-6294a90aeb1a", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["5-Lipoxygenase Inhibitor [EPC]", "5-Lipoxygenase Inhibitors [MoA]", "Decreased Leukotriene Production [PE]"], "product_ndc": "72603-246", "generic_name": "Zileuton", "labeler_name": "NorthStar RxLLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Zileuton", "active_ingredients": [{"name": "ZILEUTON", "strength": "600 mg/1"}], "application_number": "ANDA215742", "marketing_category": "ANDA", "marketing_start_date": "20240501", "listing_expiration_date": "20261231"}