flurandrenolide

Generic: flurandrenolide

Labeler: padagis israel pharmaceuticals ltd
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name flurandrenolide
Generic Name flurandrenolide
Labeler padagis israel pharmaceuticals ltd
Dosage Form LOTION
Routes
TOPICAL
Active Ingredients

flurandrenolide .5 mg/mL

Manufacturer
Padagis Israel Pharmaceuticals Ltd

Identifiers & Regulatory

Product NDC 45802-928
Product ID 45802-928_a5be325d-6006-40c1-bace-5adcf29548e5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207133
Listing Expiration 2026-12-31
Marketing Start 2016-10-06

Pharmacologic Class

Established (EPC)
corticosteroid [epc]
Mechanism of Action
corticosteroid hormone receptor agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 45802928
Hyphenated Format 45802-928

Supplemental Identifiers

RxCUI
197719
UNII
8EUL29XUQT
NUI
N0000175576 N0000175450

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 flurandrenolide (source: ndc)
Generic Name flurandrenolide (source: ndc)
Application Number ANDA207133 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/mL
source: ndc
Packaging
  • 120 mL in 1 BOTTLE, PLASTIC (45802-928-03)
source: ndc

Packages (1)

45802-928-03 120 mL in 1 BOTTLE, PLASTIC (45802-928-03)

Ingredients (1)

flurandrenolide (.5 mg/mL)

Linked Drug Pages (1)

Flurandrenolide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "a5be325d-6006-40c1-bace-5adcf29548e5", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["8EUL29XUQT"], "rxcui": ["197719"], "spl_set_id": ["9c4f5aea-2e08-400c-88f6-d9e3013afda7"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Padagis Israel Pharmaceuticals Ltd"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 mL in 1 BOTTLE, PLASTIC (45802-928-03)", "package_ndc": "45802-928-03", "marketing_start_date": "20161006"}], "brand_name": "Flurandrenolide", "product_id": "45802-928_a5be325d-6006-40c1-bace-5adcf29548e5", "dosage_form": "LOTION", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "45802-928", "generic_name": "Flurandrenolide", "labeler_name": "Padagis Israel Pharmaceuticals Ltd", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Flurandrenolide", "active_ingredients": [{"name": "FLURANDRENOLIDE", "strength": ".5 mg/mL"}], "application_number": "ANDA207133", "marketing_category": "ANDA", "marketing_start_date": "20161006", "listing_expiration_date": "20261231"}