iluvien

Generic: fluocinolone acetonide

Labeler: ani pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name iluvien
Generic Name fluocinolone acetonide
Labeler ani pharmaceuticals, inc.
Dosage Form IMPLANT
Routes
INTRAVITREAL
Active Ingredients

fluocinolone acetonide .19 mg/1

Manufacturer
ANI Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68611-190
Product ID 68611-190_78b978f0-fc11-11f0-b558-0800200c9a66
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA201923
Listing Expiration 2027-12-31
Marketing Start 2014-10-15

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 68611190
Hyphenated Format 68611-190

Supplemental Identifiers

RxCUI
1552351 1552356
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 iluvien (source: ndc)
Generic Name fluocinolone acetonide (source: ndc)
Application Number NDA201923 (source: ndc)
Routes
INTRAVITREAL
source: ndc

Resolved Composition

Strengths
  • .19 mg/1
source: ndc
Packaging
  • 1 TRAY in 1 CARTON (68611-190-02) / 1 APPLICATOR in 1 TRAY / 1 IMPLANT in 1 APPLICATOR
source: ndc

Packages (1)

68611-190-02 1 TRAY in 1 CARTON (68611-190-02) / 1 APPLICATOR in 1 TRAY / 1 IMPLANT in 1 APPLICATOR

Ingredients (1)

fluocinolone acetonide (.19 mg/1)

Linked Drug Pages (1)

Iluvien ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVITREAL"], "spl_id": "78b978f0-fc11-11f0-b558-0800200c9a66", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["0CD5FD6S2M"], "rxcui": ["1552351", "1552356"], "spl_set_id": ["4400e471-7402-11df-93f2-0800200c9a66"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["ANI Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TRAY in 1 CARTON (68611-190-02)  / 1 APPLICATOR in 1 TRAY / 1 IMPLANT in 1 APPLICATOR", "package_ndc": "68611-190-02", "marketing_start_date": "20141015"}], "brand_name": "Iluvien", "product_id": "68611-190_78b978f0-fc11-11f0-b558-0800200c9a66", "dosage_form": "IMPLANT", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "68611-190", "generic_name": "fluocinolone acetonide", "labeler_name": "ANI Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Iluvien", "active_ingredients": [{"name": "FLUOCINOLONE ACETONIDE", "strength": ".19 mg/1"}], "application_number": "NDA201923", "marketing_category": "NDA", "marketing_start_date": "20141015", "listing_expiration_date": "20271231"}