FDA.reportPublic FDA data

IZERVAY

Product NDC
82829-002
11-digit product format
828290002
Labeler code
82829
Product ID
82829-002_7eb1c0ad-51ef-4edd-9f71-558f4e53b07c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
avacincaptad pegol
Dosage form
INJECTION
Route
INTRAVITREAL
Labeler
Astellas Pharma US, Inc.
Application
NDA217225
Marketing category
NDA
Marketing start
2023-08-19
Substance
AVACINCAPTAD PEGOL SODIUM
Active strength
20 mg/mL
Pharmacologic classes
Complement Inhibitor [EPC], Complement Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N217225-001IZERVAYAVACINCAPTAD PEGOL SODIUMEQ 2MG BASE/0.1ML (EQ 2MG BASE/0.1ML)SOLUTION / INTRAVITREALRLD, RS2023-08-04

Orange Book patents#

Current patent rows page 1 of 1 · 6 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N217225-00182367732026-11-11U-36732023-08-31
N217225-00175794562027-02-14Drug substance2023-08-31
N217225-00196175462027-02-14U-3673Drug substance2023-08-31
N217225-001112731712034-07-11U-36732023-08-31
N217225-001114911762034-07-11U-36732023-08-31
N217225-001120168752034-07-11U-36732024-10-01

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N217225-001IZERVAYEQ 2MG BASE/0.1ML (EQ 2MG BASE/0.1ML)SOLUTION / INTRAVITREALRLD, RS2023-08-0484e616aacf4f…
2026-08-18 06:07:402026-07N217225-001IZERVAYEQ 2MG BASE/0.1ML (EQ 2MG BASE/0.1ML)SOLUTION / INTRAVITREALRLD, RS2023-08-04caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N217225-001IZERVAYEQ 2MG BASE/0.1ML (EQ 2MG BASE/0.1ML)SOLUTION / INTRAVITREALRLD, RS2023-08-04011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217225-001IZERVAYEQ 2MG BASE/0.1ML (EQ 2MG BASE/0.1ML)SOLUTION / INTRAVITREALRLD, RS2023-08-0431067a03dcf5…
2025-08-23 18:47 UTC2025-08N217225-001IZERVAYEQ 2MG BASE/0.1ML (EQ 2MG BASE/0.1ML)SOLUTION / INTRAVITREALRLD, RS2023-08-046a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N217225-001IZERVAYEQ 2MG BASE/0.1ML (EQ 2MG BASE/0.1ML)SOLUTION / INTRAVITREALRLD, RS2023-08-04fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N217225-001IZERVAYEQ 2MG BASE/0.1ML (EQ 2MG BASE/0.1ML)SOLUTION / INTRAVITREALRLD, RS2023-08-04b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N217225-001IZERVAYEQ 2MG BASE/0.1ML (EQ 2MG BASE/0.1ML)SOLUTION / INTRAVITREALRLD, RS2023-08-0403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N217225-001IZERVAYEQ 2MG BASE/0.1ML (EQ 2MG BASE/0.1ML)SOLUTION / INTRAVITREALRLD, RS2023-08-042680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N217225-001IZERVAYEQ 2MG BASE/0.1ML (EQ 2MG BASE/0.1ML)SOLUTION / INTRAVITREALRLD, RS2023-08-045bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N217225-001IZERVAYEQ 2MG BASE/0.1ML (EQ 2MG BASE/0.1ML)SOLUTION / INTRAVITREALRLD, RS2023-08-04d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N217225-001IZERVAYEQ 2MG BASE/0.1ML (EQ 2MG BASE/0.1ML)SOLUTION / INTRAVITREALRLD, RS2023-08-04d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N217225-001IZERVAYEQ 2MG BASE/0.1ML (EQ 2MG BASE/0.1ML)SOLUTION / INTRAVITREALRLD, RS2023-08-0479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N217225-001IZERVAYEQ 2MG BASE/0.1ML (EQ 2MG BASE/0.1ML)SOLUTION / INTRAVITREALRLD, RS2023-08-04301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N217225-001IZERVAYEQ 2MG BASE/0.1ML (EQ 2MG BASE/0.1ML)SOLUTION / INTRAVITREALRLD, RS2023-08-041e350fbaab3a…
2024-05-31 18:47 UTC2024-05N217225-001IZERVAYEQ 2MG BASE/0.1ML (EQ 2MG BASE/0.1ML)SOLUTION / INTRAVITREALRLD, RS2023-08-048072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N217225-001IZERVAYEQ 2MG BASE/0.1ML (EQ 2MG BASE/0.1ML)SOLUTION / INTRAVITREALRLD, RS2023-08-046a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N217225-001IZERVAYEQ 2MG BASE/0.1ML (EQ 2MG BASE/0.1ML)SOLUTION / INTRAVITREALRLD, RS2023-08-041c564ffb4f44…
2023-12-20 04:57 UTC2023-12N217225-001IZERVAYEQ 2MG BASE/0.1ML (EQ 2MG BASE/0.1ML)SOLUTION / INTRAVITREALRLD, RS2023-08-04ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N217225-001IZERVAYEQ 2MG BASE/0.1ML (EQ 2MG BASE/0.1ML)SOLUTION / INTRAVITREALRLD, RS2023-08-04a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N217225-001IZERVAYEQ 2MG BASE/0.1ML (EQ 2MG BASE/0.1ML)SOLUTION / INTRAVITREALRLD, RS2023-08-049b2671bbb829…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N217225-001IZERVAYEQ 2MG BASE/0.1ML (EQ 2MG BASE/0.1ML)SOLUTION / INTRAVITREALRLD, RS2023-08-04a50c72e98297…

Observed Orange Book patent history#

Patent history page 1 of 5 · 176 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-09-14 22:38:342026-08N217225-00182367732026-11-11U-36732023-08-3184e616aacf4f…
2026-09-14 22:38:342026-08N217225-00175794562027-02-14Drug substance2023-08-3184e616aacf4f…
2026-09-14 22:38:342026-08N217225-00196175462027-02-14U-3673Drug substance2023-08-3184e616aacf4f…
2026-09-14 22:38:342026-08N217225-001112731712034-07-11U-36732023-08-3184e616aacf4f…
2026-09-14 22:38:342026-08N217225-001114911762034-07-11U-36732023-08-3184e616aacf4f…
2026-09-14 22:38:342026-08N217225-001120168752034-07-11U-36732024-10-0184e616aacf4f…
2026-08-18 06:07:402026-07N217225-00182367732026-11-11U-36732023-08-31caaa826d4ba7…
2026-08-18 06:07:402026-07N217225-00175794562027-02-14Drug substance2023-08-31caaa826d4ba7…
2026-08-18 06:07:402026-07N217225-00196175462027-02-14U-3673Drug substance2023-08-31caaa826d4ba7…
2026-08-18 06:07:402026-07N217225-001112731712034-07-11U-36732023-08-31caaa826d4ba7…
2026-08-18 06:07:402026-07N217225-001114911762034-07-11U-36732023-08-31caaa826d4ba7…
2026-08-18 06:07:402026-07N217225-001120168752034-07-11U-36732024-10-01caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N217225-00182367732026-11-11U-36732023-08-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217225-00175794562027-02-14Drug substance2023-08-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217225-00196175462027-02-14U-3673Drug substance2023-08-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217225-001112731712034-07-11U-36732023-08-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217225-001114911762034-07-11U-36732023-08-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217225-001120168752034-07-11U-36732024-10-01011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217225-001109475442025-02-14U-3673Drug substance2023-08-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217225-00175382112025-02-14Drug substance2023-08-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217225-00178039312025-02-14Drug substance2023-08-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217225-00175794562026-02-14Drug substance2023-08-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217225-00196175462026-02-14U-3673Drug substance2023-08-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217225-00182367732026-11-11U-36732023-08-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217225-001112731712034-07-11U-36732023-08-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217225-001114911762034-07-11U-36732023-08-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217225-001120168752034-07-11U-36732024-10-0131067a03dcf5…
2025-08-23 18:47 UTC2025-08N217225-001109475442025-02-14U-3673Drug substance2023-08-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08N217225-00175382112025-02-14Drug substance2023-08-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08N217225-00178039312025-02-14Drug substance2023-08-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08N217225-00175794562026-02-14Drug substance2023-08-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08N217225-00196175462026-02-14U-3673Drug substance2023-08-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08N217225-00182367732026-11-11U-36732023-08-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08N217225-001112731712034-07-11U-36732023-08-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08N217225-001114911762034-07-11U-36732023-08-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08N217225-001120168752034-07-11U-36732024-10-016a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N217225-001109475442025-02-14U-3673Drug substance2023-08-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N217225-00175382112025-02-14Drug substance2023-08-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N217225-00178039312025-02-14Drug substance2023-08-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N217225-00175794562026-02-14Drug substance2023-08-31fd3edfee7708…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
IZERVAY
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVACINCAPTAD PEGOL SODIUM20 mg/mL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
da30c6be-7003-4c1d-80f6-8702f31484b9Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82829-002-01IZERVAY0.35 mL in 1 VIAL, SINGLE-DOSEINJECTION0.359
82829-002-01IZERVAY1 in 1 CARTONINJECTION19
82829-002-99IZERVAY1 in 1 CARTONINJECTION19
82829-002-99IZERVAY0.35 mL in 1 VIAL, SINGLE-DOSEINJECTION0.359

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82829-002-01ML - Milliliter82829-00237715c7b-c268-4ef7-b9d7-5992e81d1fd712023-09-05
82829-002-99ML - Milliliter82829-00219d011e6-4e6f-4ca9-901e-065f9d6c65a512024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82829-002IZERVAY (AVACINCAPTAD PEGOL) INJECTION [ASTELLAS PHARMA US, INC.]8Current NDC, 4 package rows20250316_1642fe6a-dc26-4d20-ae6e-654af744e3bd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2645112avacincapted pegol 2 MG in 0.1 ML InjectionPSN1642fe6a-dc26-4d20-ae6e-654af744e3bd9
2645118izervay 2 MG in 0.1 ML InjectionPSN1642fe6a-dc26-4d20-ae6e-654af744e3bd9
26451180.1 ML avacincaptad pegol 20 MG/ML Injection [Izervay]SBD1642fe6a-dc26-4d20-ae6e-654af744e3bd9
26451120.1 ML avacincaptad pegol 20 MG/ML InjectionSCD1642fe6a-dc26-4d20-ae6e-654af744e3bd9
26451180.1 ML Izervay 20 MG/ML InjectionSY1642fe6a-dc26-4d20-ae6e-654af744e3bd9
2645112avacincapted pegol 2 MG per 0.1 ML InjectionSY1642fe6a-dc26-4d20-ae6e-654af744e3bd9
2645118Izervay 2 MG per 0.1 ML InjectionSY1642fe6a-dc26-4d20-ae6e-654af744e3bd9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
82829-002-01828290002011 VIAL, SINGLE-DOSE in 1 CARTON (82829-002-01) / .35 mL in 1 VIAL, SINGLE-DOSE2023-08-19NoNoCurrent
82829-002-99828290002991 VIAL, SINGLE-DOSE in 1 CARTON (82829-002-99) / .35 mL in 1 VIAL, SINGLE-DOSE2023-08-19YesNoCurrent