fluocinolone acetonide

Generic: fluocinolone acetonide

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

Drug Facts

Product Profile

Brand Name fluocinolone acetonide
Generic Name fluocinolone acetonide
Labeler padagis israel pharmaceuticals ltd
Dosage Form OIL
Routes
AURICULAR (OTIC)
Active Ingredients

fluocinolone acetonide .11 mg/mL

Manufacturer
Padagis Israel Pharmaceuticals Ltd

Identifiers & Regulatory

Product NDC 45802-009
Product ID 45802-009_8512259d-c8ce-4b9c-ad3b-0d97b9a86077
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202849
Listing Expiration 2026-12-31
Marketing Start 2017-10-04

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 45802009
Hyphenated Format 45802-009

Supplemental Identifiers

RxCUI
1191299
UNII
0CD5FD6S2M
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 fluocinolone acetonide (source: ndc)
Generic Name fluocinolone acetonide (source: ndc)
Application Number ANDA202849 (source: ndc)
Routes
AURICULAR (OTIC)
source: ndc

Resolved Composition

Strengths
  • .11 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (45802-009-10) / 20 mL in 1 BOTTLE
source: ndc

Packages (1)

45802-009-10 1 BOTTLE in 1 CARTON (45802-009-10) / 20 mL in 1 BOTTLE

Ingredients (1)

fluocinolone acetonide (.11 mg/mL)

Linked Drug Pages (1)

Fluocinolone Acetonide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["AURICULAR (OTIC)"], "spl_id": "8512259d-c8ce-4b9c-ad3b-0d97b9a86077", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["0CD5FD6S2M"], "rxcui": ["1191299"], "spl_set_id": ["e6af2549-50b5-4b7f-a0c0-de0f7626b6f3"], "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": "1 BOTTLE in 1 CARTON (45802-009-10)  / 20 mL in 1 BOTTLE", "package_ndc": "45802-009-10", "marketing_start_date": "20171004"}], "brand_name": "Fluocinolone Acetonide", "product_id": "45802-009_8512259d-c8ce-4b9c-ad3b-0d97b9a86077", "dosage_form": "OIL", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "45802-009", "generic_name": "Fluocinolone Acetonide", "labeler_name": "Padagis Israel Pharmaceuticals Ltd", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fluocinolone Acetonide", "active_ingredients": [{"name": "FLUOCINOLONE ACETONIDE", "strength": ".11 mg/mL"}], "application_number": "ANDA202849", "marketing_category": "ANDA", "marketing_start_date": "20171004", "listing_expiration_date": "20261231"}