izervay

Generic: avacincaptad pegol

Labeler: astellas pharma us, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name izervay
Generic Name avacincaptad pegol
Labeler astellas pharma us, inc.
Dosage Form INJECTION
Routes
INTRAVITREAL
Active Ingredients

avacincaptad pegol sodium 20 mg/mL

Manufacturer
Astellas Pharma US, Inc.

Identifiers & Regulatory

Product NDC 82829-002
Product ID 82829-002_2b425f68-5939-4195-a281-393b10eba889
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA217225
Listing Expiration 2026-12-31
Marketing Start 2023-08-19

Pharmacologic Class

Classes
complement inhibitor [epc] complement inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 82829002
Hyphenated Format 82829-002

Supplemental Identifiers

RxCUI
2645112 2645118
UNII
K86ENL12I5

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 izervay (source: ndc)
Generic Name avacincaptad pegol (source: ndc)
Application Number NDA217225 (source: ndc)
Routes
INTRAVITREAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (82829-002-01) / .35 mL in 1 VIAL, SINGLE-DOSE
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (82829-002-99) / .35 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (2)

82829-002-01 1 VIAL, SINGLE-DOSE in 1 CARTON (82829-002-01) / .35 mL in 1 VIAL, SINGLE-DOSE 82829-002-99 1 VIAL, SINGLE-DOSE in 1 CARTON (82829-002-99) / .35 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

avacincaptad pegol sodium (20 mg/mL)

Linked Drug Pages (1)

IZERVAY ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVITREAL"], "spl_id": "2b425f68-5939-4195-a281-393b10eba889", "openfda": {"unii": ["K86ENL12I5"], "rxcui": ["2645112", "2645118"], "spl_set_id": ["1642fe6a-dc26-4d20-ae6e-654af744e3bd"], "manufacturer_name": ["Astellas Pharma US, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (82829-002-01)  / .35 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "82829-002-01", "marketing_start_date": "20230819"}, {"sample": true, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (82829-002-99)  / .35 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "82829-002-99", "marketing_start_date": "20230819"}], "brand_name": "IZERVAY", "product_id": "82829-002_2b425f68-5939-4195-a281-393b10eba889", "dosage_form": "INJECTION", "pharm_class": ["Complement Inhibitor [EPC]", "Complement Inhibitors [MoA]"], "product_ndc": "82829-002", "generic_name": "avacincaptad pegol", "labeler_name": "Astellas Pharma US, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "IZERVAY", "active_ingredients": [{"name": "AVACINCAPTAD PEGOL SODIUM", "strength": "20 mg/mL"}], "application_number": "NDA217225", "marketing_category": "NDA", "marketing_start_date": "20230819", "listing_expiration_date": "20261231"}