zileuton

Generic: zileuton

Labeler: rising pharma holdings, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name zileuton
Generic Name zileuton
Labeler rising pharma holdings, inc.
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

zileuton 600 mg/1

Manufacturer
Rising Pharma Holdings, Inc.

Identifiers & Regulatory

Product NDC 64980-206
Product ID 64980-206_984587a3-4875-4ad3-af6e-11b90fe705a8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204929
Listing Expiration 2026-12-31
Marketing Start 2017-03-21

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 64980206
Hyphenated Format 64980-206

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 ANDA204929 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 600 mg/1
source: ndc
Packaging
  • 120 TABLET, EXTENDED RELEASE in 1 BOTTLE (64980-206-12)
source: ndc

Packages (1)

64980-206-12 120 TABLET, EXTENDED RELEASE in 1 BOTTLE (64980-206-12)

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": "984587a3-4875-4ad3-af6e-11b90fe705a8", "openfda": {"nui": ["N0000175956", "N0000175955", "N0000008683"], "unii": ["V1L22WVE2S"], "rxcui": ["730834"], "spl_set_id": ["fd382540-b390-4e86-a94a-988ea89c93a8"], "pharm_class_pe": ["Decreased Leukotriene Production [PE]"], "pharm_class_epc": ["5-Lipoxygenase Inhibitor [EPC]"], "pharm_class_moa": ["5-Lipoxygenase Inhibitors [MoA]"], "manufacturer_name": ["Rising Pharma Holdings, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 TABLET, EXTENDED RELEASE in 1 BOTTLE (64980-206-12)", "package_ndc": "64980-206-12", "marketing_start_date": "20170321"}], "brand_name": "Zileuton", "product_id": "64980-206_984587a3-4875-4ad3-af6e-11b90fe705a8", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["5-Lipoxygenase Inhibitor [EPC]", "5-Lipoxygenase Inhibitors [MoA]", "Decreased Leukotriene Production [PE]"], "product_ndc": "64980-206", "generic_name": "Zileuton", "labeler_name": "Rising Pharma Holdings, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Zileuton", "active_ingredients": [{"name": "ZILEUTON", "strength": "600 mg/1"}], "application_number": "ANDA204929", "marketing_category": "ANDA", "marketing_start_date": "20170321", "listing_expiration_date": "20261231"}