zileuton

Generic: zileuton

Labeler: camber pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name zileuton
Generic Name zileuton
Labeler camber pharmaceuticals, inc.
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

zileuton 600 mg/1

Manufacturer
Camber Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 31722-044
Product ID 31722-044_eaf892a4-41c4-70e0-e053-2995a90a2079
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215742
Listing Expiration 2026-12-31
Marketing Start 2022-10-11

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 31722044
Hyphenated Format 31722-044

Supplemental Identifiers

RxCUI
730834
UPC
0331722044127
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 (31722-044-12)
source: ndc

Packages (1)

31722-044-12 120 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (31722-044-12)

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": "eaf892a4-41c4-70e0-e053-2995a90a2079", "openfda": {"nui": ["N0000175956", "N0000175955", "N0000008683"], "upc": ["0331722044127"], "unii": ["V1L22WVE2S"], "rxcui": ["730834"], "spl_set_id": ["94313e24-9534-4b6c-b374-c436c4916303"], "pharm_class_pe": ["Decreased Leukotriene Production [PE]"], "pharm_class_epc": ["5-Lipoxygenase Inhibitor [EPC]"], "pharm_class_moa": ["5-Lipoxygenase Inhibitors [MoA]"], "manufacturer_name": ["Camber Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (31722-044-12)", "package_ndc": "31722-044-12", "marketing_start_date": "20221011"}], "brand_name": "Zileuton", "product_id": "31722-044_eaf892a4-41c4-70e0-e053-2995a90a2079", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["5-Lipoxygenase Inhibitor [EPC]", "5-Lipoxygenase Inhibitors [MoA]", "Decreased Leukotriene Production [PE]"], "product_ndc": "31722-044", "generic_name": "Zileuton", "labeler_name": "Camber Pharmaceuticals, Inc.", "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": "20221011", "listing_expiration_date": "20261231"}