FDA.reportPublic FDA data

IZERVAY

Product NDC
82829-002
11-digit product format
828290002
Labeler code
82829
Product ID
82829-002_7fc0afa6-193a-413b-b5be-39c1069b1110
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 1.

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
2026-02-19 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 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
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…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N217225-00196175462026-02-14U-3673Drug substance2023-08-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N217225-00182367732026-11-11U-36732023-08-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N217225-001112731712034-07-11U-36732023-08-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N217225-001114911762034-07-11U-36732023-08-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N217225-001120168752034-07-11U-36732024-10-01fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N217225-001109475442025-02-14U-3673Drug substance2023-08-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N217225-00175382112025-02-14Drug substance2023-08-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N217225-00175794562025-02-14Drug substance2023-08-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N217225-00178039312025-02-14Drug substance2023-08-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N217225-00196175462025-02-14U-3673Drug substance2023-08-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N217225-00182367732026-11-11U-36732023-08-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N217225-001112731712034-07-11U-36732023-08-31b8a1b40f171c…

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
K86ENL12I5Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2645112Internal RxNorm lookup
2645118Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1642fe6a-dc26-4d20-ae6e-654af744e3bdAvailable on FDA.report

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IZERVAYAVACINCAPTAD PEGOLAstellas Pharma US, Inc.1642fe6a-dc26-4d20-ae6e-654af744e3bd2026-02-27Warnings, Adverse reactionsExact identifier
application applno (NDA): 217225
application number: NDA217225
ndc (product): 82829-002

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