zileuton

Generic: zileuton

Labeler: strides pharma science limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name zileuton
Generic Name zileuton
Labeler strides pharma science limited
Dosage Form TABLET, MULTILAYER, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

zileuton 600 mg/1

Manufacturer
Strides Pharma Science Limited

Identifiers & Regulatory

Product NDC 64380-189
Product ID 64380-189_4bb0aa92-80d2-4cbc-9261-012f3b5eb1c1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212670
Listing Expiration 2026-12-31
Marketing Start 2022-10-15

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 64380189
Hyphenated Format 64380-189

Supplemental Identifiers

RxCUI
730834
UPC
0364380189015
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 ANDA212670 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 600 mg/1
source: ndc
Packaging
  • 120 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE (64380-189-01)
source: ndc

Packages (1)

64380-189-01 120 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE (64380-189-01)

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": "4bb0aa92-80d2-4cbc-9261-012f3b5eb1c1", "openfda": {"nui": ["N0000175956", "N0000175955", "N0000008683"], "upc": ["0364380189015"], "unii": ["V1L22WVE2S"], "rxcui": ["730834"], "spl_set_id": ["a826d16f-df07-447b-b050-b9a02ea1f89e"], "pharm_class_pe": ["Decreased Leukotriene Production [PE]"], "pharm_class_epc": ["5-Lipoxygenase Inhibitor [EPC]"], "pharm_class_moa": ["5-Lipoxygenase Inhibitors [MoA]"], "manufacturer_name": ["Strides Pharma Science Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE (64380-189-01)", "package_ndc": "64380-189-01", "marketing_start_date": "20221015"}], "brand_name": "Zileuton", "product_id": "64380-189_4bb0aa92-80d2-4cbc-9261-012f3b5eb1c1", "dosage_form": "TABLET, MULTILAYER, EXTENDED RELEASE", "pharm_class": ["5-Lipoxygenase Inhibitor [EPC]", "5-Lipoxygenase Inhibitors [MoA]", "Decreased Leukotriene Production [PE]"], "product_ndc": "64380-189", "generic_name": "zileuton", "labeler_name": "Strides Pharma Science Limited", "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": "20221015", "listing_expiration_date": "20261231"}