ilevro

Generic: nepafenac

Labeler: harrow eye, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name ilevro
Generic Name nepafenac
Labeler harrow eye, llc
Dosage Form SUSPENSION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

nepafenac 3 mg/mL

Manufacturer
Harrow Eye, LLC

Identifiers & Regulatory

Product NDC 82667-400
Product ID 82667-400_4a2fe11b-eabd-76bd-e063-6394a90ab568
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA203491
Listing Expiration 2027-12-31
Marketing Start 2024-05-01

Pharmacologic Class

Established (EPC)
nonsteroidal anti-inflammatory drug [epc]
Mechanism of Action
cyclooxygenase inhibitors [moa]
Chemical Structure
anti-inflammatory agents, non-steroidal [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 82667400
Hyphenated Format 82667-400

Supplemental Identifiers

RxCUI
1362132 1365866
UNII
0J9L7J6V8C
NUI
N0000000160 M0001335 N0000175722

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 ilevro (source: ndc)
Generic Name nepafenac (source: ndc)
Application Number NDA203491 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 3 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 CARTON (82667-400-03) / 3 mL in 1 BOTTLE, PLASTIC
source: ndc

Packages (1)

82667-400-03 1 BOTTLE, PLASTIC in 1 CARTON (82667-400-03) / 3 mL in 1 BOTTLE, PLASTIC

Ingredients (1)

nepafenac (3 mg/mL)

Linked Drug Pages (1)

ILEVRO ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "4a2fe11b-eabd-76bd-e063-6394a90ab568", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["0J9L7J6V8C"], "rxcui": ["1362132", "1365866"], "spl_set_id": ["10f411d3-a81e-074a-e063-6294a90ab547"], "pharm_class_cs": ["Anti-Inflammatory Agents, Non-Steroidal [CS]"], "pharm_class_epc": ["Nonsteroidal Anti-inflammatory Drug [EPC]"], "pharm_class_moa": ["Cyclooxygenase Inhibitors [MoA]"], "manufacturer_name": ["Harrow Eye, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (82667-400-03)  / 3 mL in 1 BOTTLE, PLASTIC", "package_ndc": "82667-400-03", "marketing_start_date": "20240501"}], "brand_name": "ILEVRO", "product_id": "82667-400_4a2fe11b-eabd-76bd-e063-6394a90ab568", "dosage_form": "SUSPENSION/ DROPS", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "82667-400", "generic_name": "nepafenac", "labeler_name": "Harrow Eye, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ILEVRO", "active_ingredients": [{"name": "NEPAFENAC", "strength": "3 mg/mL"}], "application_number": "NDA203491", "marketing_category": "NDA", "marketing_start_date": "20240501", "listing_expiration_date": "20271231"}