zileuton

Generic: zileuton

Labeler: golden state medical supply, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name zileuton
Generic Name zileuton
Labeler golden state medical supply, inc.
Dosage Form TABLET, MULTILAYER, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

zileuton 600 mg/1

Manufacturer
Golden State Medical Supply, Inc.

Identifiers & Regulatory

Product NDC 51407-741
Product ID 51407-741_f7573809-771b-04c9-e053-6294a90ab193
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212670
Listing Expiration 2026-12-31
Marketing Start 2019-12-16

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 51407741
Hyphenated Format 51407-741

Supplemental Identifiers

RxCUI
730834
UNII
V1L22WVE2S
NUI
N0000175956 N0000175955 N0000008683

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 ANDA212670 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 600 mg/1
source: ndc
Packaging
  • 120 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE (51407-741-12)
source: ndc

Packages (1)

51407-741-12 120 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE (51407-741-12)

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": "f7573809-771b-04c9-e053-6294a90ab193", "openfda": {"nui": ["N0000175956", "N0000175955", "N0000008683"], "unii": ["V1L22WVE2S"], "rxcui": ["730834"], "spl_set_id": ["f7573809-7741-04c9-e053-6294a90ab193"], "pharm_class_pe": ["Decreased Leukotriene Production [PE]"], "pharm_class_epc": ["5-Lipoxygenase Inhibitor [EPC]"], "pharm_class_moa": ["5-Lipoxygenase Inhibitors [MoA]"], "manufacturer_name": ["Golden State Medical Supply, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "120 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE (51407-741-12)", "package_ndc": "51407-741-12", "marketing_start_date": "20230119"}], "brand_name": "Zileuton", "product_id": "51407-741_f7573809-771b-04c9-e053-6294a90ab193", "dosage_form": "TABLET, MULTILAYER, EXTENDED RELEASE", "pharm_class": ["5-Lipoxygenase Inhibitor [EPC]", "5-Lipoxygenase Inhibitors [MoA]", "Decreased Leukotriene Production [PE]"], "product_ndc": "51407-741", "generic_name": "zileuton", "labeler_name": "Golden State Medical Supply, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Zileuton", "active_ingredients": [{"name": "ZILEUTON", "strength": "600 mg/1"}], "application_number": "ANDA212670", "marketing_category": "ANDA", "marketing_start_date": "20191216", "listing_expiration_date": "20261231"}