Syfovre

Product NDC
73606-020
Requested package NDC
73606-020-02
11-digit product format
736060020
Labeler code
73606
Product ID
73606-020_76e1d7d9-903f-49c1-be3a-617f682e79e7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pegcetacoplan
Dosage form
INJECTION, SOLUTION
Route
INTRAVITREAL
Labeler
Apellis Pharmaceuticals, Inc.
Application
NDA217171
Marketing category
NDA
Marketing start
2023-02-17
Substance
PEGCETACOPLAN
Active strength
15 mg/.1mL
Pharmacologic classes
Complement Inhibitor [EPC], Complement Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
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
N217171-001SYFOVREPEGCETACOPLAN15MG/0.1ML (15MG/0.1ML)SOLUTION / INTRAVITREALRLD, RS2023-02-17

Orange Book patents#

Current patent rows page 1 of 1 · 16 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N217171-00190560762026-10-25U-35402023-03-09
N217171-00181685842027-04-07U-35402023-03-09
N217171-00181685842027-04-07U-35422023-03-09
N217171-00191693072027-11-18U-3541Drug substance2023-03-09
N217171-00178883232027-12-04Drug substance2023-03-09
N217171-00179895892027-12-04Drug substance2023-03-09
N217171-001116614412033-01-13U-3540Drug substance2023-06-26
N217171-001101251712033-08-02Drug substance2023-03-09
N217171-001100358222033-11-15Drug substance2023-03-09
N217171-001108758932033-11-15U-3540Drug substance2023-03-09
N217171-001112928152033-11-15U-3540Drug substance, Drug product2023-03-09
N217171-001125288362036-10-07U-43942026-01-23
N217171-001119039942037-02-22U-38262024-03-18
N217171-001119039942037-02-22U-38272024-03-18
N217171-001119039942037-02-22U-38282024-03-18
N217171-001124586952038-12-14Drug product2025-11-07

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 2 matching rows.

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N217171-001NP2026-02-22
N217171-001NCE2026-05-14

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 22:38:342026-08N217171-001SYFOVRE15MG/0.1ML (15MG/0.1ML)SOLUTION / INTRAVITREALRLD, RS2023-02-1784e616aacf4f…
2026-08-18 06:07:402026-07N217171-001SYFOVRE15MG/0.1ML (15MG/0.1ML)SOLUTION / INTRAVITREALRLD, RS2023-02-17caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N217171-001SYFOVRE15MG/0.1ML (15MG/0.1ML)SOLUTION / INTRAVITREALRLD, RS2023-02-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217171-001SYFOVRE15MG/0.1ML (15MG/0.1ML)SOLUTION / INTRAVITREALRLD, RS2023-02-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08N217171-001SYFOVRE15MG/0.1ML (15MG/0.1ML)SOLUTION / INTRAVITREALRLD, RS2023-02-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N217171-001SYFOVRE15MG/0.1ML (15MG/0.1ML)SOLUTION / INTRAVITREALRLD, RS2023-02-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N217171-001SYFOVRE15MG/0.1ML (15MG/0.1ML)SOLUTION / INTRAVITREALRLD, RS2023-02-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N217171-001SYFOVRE15MG/0.1ML (15MG/0.1ML)SOLUTION / INTRAVITREALRLD, RS2023-02-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N217171-001SYFOVRE15MG/0.1ML (15MG/0.1ML)SOLUTION / INTRAVITREALRLD, RS2023-02-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N217171-001SYFOVRE15MG/0.1ML (15MG/0.1ML)SOLUTION / INTRAVITREALRLD, RS2023-02-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N217171-001SYFOVRE15MG/0.1ML (15MG/0.1ML)SOLUTION / INTRAVITREALRLD, RS2023-02-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N217171-001SYFOVRE15MG/0.1ML (15MG/0.1ML)SOLUTION / INTRAVITREALRLD, RS2023-02-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N217171-001SYFOVRE15MG/0.1ML (15MG/0.1ML)SOLUTION / INTRAVITREALRLD, RS2023-02-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N217171-001SYFOVRE15MG/0.1ML (15MG/0.1ML)SOLUTION / INTRAVITREALRLD, RS2023-02-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N217171-001SYFOVRE15MG/0.1ML (15MG/0.1ML)SOLUTION / INTRAVITREALRLD, RS2023-02-171e350fbaab3a…
2024-05-31 18:47 UTC2024-05N217171-001SYFOVRE15MG/0.1ML (15MG/0.1ML)SOLUTION / INTRAVITREALRLD, RS2023-02-178072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N217171-001SYFOVRE15MG/0.1ML (15MG/0.1ML)SOLUTION / INTRAVITREALRLD, RS2023-02-176a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N217171-001SYFOVRE15MG/0.1ML (15MG/0.1ML)SOLUTION / INTRAVITREALRLD, RS2023-02-171c564ffb4f44…
2023-12-20 04:57 UTC2023-12N217171-001SYFOVRE15MG/0.1ML (15MG/0.1ML)SOLUTION / INTRAVITREALRLD, RS2023-02-17ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N217171-001SYFOVRE15MG/0.1ML (15MG/0.1ML)SOLUTION / INTRAVITREALRLD, RS2023-02-17a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N217171-001SYFOVRE15MG/0.1ML (15MG/0.1ML)SOLUTION / INTRAVITREALRLD, RS2023-02-179b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N217171-001SYFOVRE15MG/0.1ML (15MG/0.1ML)SOLUTION / INTRAVITREALRLD, RS2023-02-17a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N217171-001SYFOVRE15MG/0.1ML (15MG/0.1ML)SOLUTION / INTRAVITREALRLD, RS2023-02-173f0d92c62455…
2023-05-13 08:27 UTC2023-05N217171-001SYFOVRE15MG/0.1ML (15MG/0.1ML)SOLUTION / INTRAVITREALRLD, RS2023-02-17053a50430f4f…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N217171-001SYFOVRE15MG/0.1ML (15MG/0.1ML)SOLUTION / INTRAVITREALRLD, RS2023-02-17a50c72e98297…

Observed Orange Book patent history#

Patent history page 1 of 9 · 333 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-09-14 22:38:342026-08N217171-00190560762026-10-25U-35402023-03-0984e616aacf4f…
2026-09-14 22:38:342026-08N217171-00181685842027-04-07U-35402023-03-0984e616aacf4f…
2026-09-14 22:38:342026-08N217171-00181685842027-04-07U-35422023-03-0984e616aacf4f…
2026-09-14 22:38:342026-08N217171-00191693072027-11-18U-3541Drug substance2023-03-0984e616aacf4f…
2026-09-14 22:38:342026-08N217171-00178883232027-12-04Drug substance2023-03-0984e616aacf4f…
2026-09-14 22:38:342026-08N217171-00179895892027-12-04Drug substance2023-03-0984e616aacf4f…
2026-09-14 22:38:342026-08N217171-001116614412033-01-13U-3540Drug substance2023-06-2684e616aacf4f…
2026-09-14 22:38:342026-08N217171-001101251712033-08-02Drug substance2023-03-0984e616aacf4f…
2026-09-14 22:38:342026-08N217171-001100358222033-11-15Drug substance2023-03-0984e616aacf4f…
2026-09-14 22:38:342026-08N217171-001108758932033-11-15U-3540Drug substance2023-03-0984e616aacf4f…
2026-09-14 22:38:342026-08N217171-001112928152033-11-15U-3540Drug substance, Drug product2023-03-0984e616aacf4f…
2026-09-14 22:38:342026-08N217171-001125288362036-10-07U-43942026-01-2384e616aacf4f…
2026-09-14 22:38:342026-08N217171-001119039942037-02-22U-38262024-03-1884e616aacf4f…
2026-09-14 22:38:342026-08N217171-001119039942037-02-22U-38272024-03-1884e616aacf4f…
2026-09-14 22:38:342026-08N217171-001119039942037-02-22U-38282024-03-1884e616aacf4f…
2026-09-14 22:38:342026-08N217171-001124586952038-12-14Drug product2025-11-0784e616aacf4f…
2026-08-18 06:07:402026-07N217171-00190560762026-10-25U-35402023-03-09caaa826d4ba7…
2026-08-18 06:07:402026-07N217171-00181685842027-04-07U-35402023-03-09caaa826d4ba7…
2026-08-18 06:07:402026-07N217171-00181685842027-04-07U-35422023-03-09caaa826d4ba7…
2026-08-18 06:07:402026-07N217171-00191693072027-11-18U-3541Drug substance2023-03-09caaa826d4ba7…
2026-08-18 06:07:402026-07N217171-00178883232027-12-04Drug substance2023-03-09caaa826d4ba7…
2026-08-18 06:07:402026-07N217171-00179895892027-12-04Drug substance2023-03-09caaa826d4ba7…
2026-08-18 06:07:402026-07N217171-001116614412033-01-13U-3540Drug substance2023-06-26caaa826d4ba7…
2026-08-18 06:07:402026-07N217171-001101251712033-08-02Drug substance2023-03-09caaa826d4ba7…
2026-08-18 06:07:402026-07N217171-001100358222033-11-15Drug substance2023-03-09caaa826d4ba7…
2026-08-18 06:07:402026-07N217171-001108758932033-11-15U-3540Drug substance2023-03-09caaa826d4ba7…
2026-08-18 06:07:402026-07N217171-001112928152033-11-15U-3540Drug substance, Drug product2023-03-09caaa826d4ba7…
2026-08-18 06:07:402026-07N217171-001125288362036-10-07U-43942026-01-23caaa826d4ba7…
2026-08-18 06:07:402026-07N217171-001119039942037-02-22U-38262024-03-18caaa826d4ba7…
2026-08-18 06:07:402026-07N217171-001119039942037-02-22U-38272024-03-18caaa826d4ba7…
2026-08-18 06:07:402026-07N217171-001119039942037-02-22U-38282024-03-18caaa826d4ba7…
2026-08-18 06:07:402026-07N217171-001124586952038-12-14Drug product2025-11-07caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N217171-00190560762026-10-25U-35402023-03-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217171-00181685842027-04-07U-35402023-03-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217171-00181685842027-04-07U-35422023-03-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217171-00191693072027-11-18U-3541Drug substance2023-03-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217171-00178883232027-12-04Drug substance2023-03-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217171-00179895892027-12-04Drug substance2023-03-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217171-001116614412033-01-13U-3540Drug substance2023-06-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217171-001101251712033-08-02Drug substance2023-03-09011fe1cb6892…

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 50 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-09-14 22:38:342026-08N217171-001NP2026-02-2284e616aacf4f…
2026-09-14 22:38:342026-08N217171-001NCE2026-05-1484e616aacf4f…
2026-08-18 06:07:402026-07N217171-001NP2026-02-22caaa826d4ba7…
2026-08-18 06:07:402026-07N217171-001NCE2026-05-14caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N217171-001NP2026-02-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217171-001NCE2026-05-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217171-001NP2026-02-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217171-001NCE2026-05-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08N217171-001NP2026-02-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08N217171-001NCE2026-05-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N217171-001NP2026-02-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N217171-001NCE2026-05-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N217171-001NP2026-02-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N217171-001NCE2026-05-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N217171-001NP2026-02-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N217171-001NCE2026-05-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N217171-001NP2026-02-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N217171-001NCE2026-05-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N217171-001NP2026-02-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N217171-001NCE2026-05-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N217171-001NP2026-02-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N217171-001NCE2026-05-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N217171-001NP2026-02-22d06236e962d9…
2024-10-29 15:01 UTC2024-10N217171-001NCE2026-05-14d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N217171-001NP2026-02-2279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N217171-001NCE2026-05-1479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N217171-001NP2026-02-22301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N217171-001NCE2026-05-14301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N217171-001NP2026-02-221e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N217171-001NCE2026-05-141e350fbaab3a…
2024-05-31 18:47 UTC2024-05N217171-001NP2026-02-228072bd15b7f6…
2024-05-31 18:47 UTC2024-05N217171-001NCE2026-05-148072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N217171-001NP2026-02-226a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N217171-001NCE2026-05-146a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N217171-001NP2026-02-221c564ffb4f44…
2024-02-18 07:12 UTC2024-02N217171-001NCE2026-05-141c564ffb4f44…
2023-12-20 04:57 UTC2023-12N217171-001NP2026-02-22ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12N217171-001NCE2026-05-14ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N217171-001NP2026-02-22a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N217171-001NCE2026-05-14a72a2bbeb626…

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
Syfovre
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PEGCETACOPLAN15 mg/.1mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
TO3JYR3BOUInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2630847Internal RxNorm lookup
2630853Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b4434e61-9ec9-4e0e-bd60-45aaa0a87e64Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
da70f326-eccc-4ddc-93bb-212c53d94fc7Product name120231002
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
d1a4c427-3368-4f7b-a9d9-d408ab477de6Product name120211208
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73606-020-01Syfovre1 in 1 CARTONINJECTION, SOLUTION112
73606-020-01Syfovre3 mL in 1 VIAL, GLASSINJECTION, SOLUTION312
73606-020-02Syfovre1 in 1 CARTONINJECTION, SOLUTION112
73606-020-02Syfovre3 mL in 1 VIAL, GLASSINJECTION, SOLUTION312
73606-020-11Syfovre1 in 1 CARTONINJECTION, SOLUTION112
73606-020-11Syfovre3 mL in 1 VIAL, GLASSINJECTION, SOLUTION312
73606-020-12Syfovre3 mL in 1 VIAL, GLASSINJECTION, SOLUTION312
73606-020-12Syfovre1 in 1 CARTONINJECTION, SOLUTION112

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
73606-020-01ML - Milliliter73606-020a7727e03-6b57-4b9d-9e5f-7de6809621be12023-03-13
73606-020-02ML - Milliliter73606-0203e1bb194-8c8f-4f34-8bde-8e46e53b1bc612025-11-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73606-020SYFOVRE (PEGCETACOPLAN) INJECTION, SOLUTION [APELLIS PHARMACEUTICALS, INC.]10Current NDC, 8 package rows20250509_b4434e61-9ec9-4e0e-bd60-45aaa0a87e64.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
SyfovrePEGCETACOPLANApellis Pharmaceuticals, Inc.b4434e61-9ec9-4e0e-bd60-45aaa0a87e642025-09-16Warnings, Adverse reactionsExact identifier
application applno (NDA): 217171
application number: NDA217171
ndc (package): 73606-020-02
ndc (product): 73606-020
ndc11 (package): 73606002002

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2630847pegcetacoplan 15 MG in 0.1 ML InjectionPSNb4434e61-9ec9-4e0e-bd60-45aaa0a87e6412
2630853SYFOVRE 15 MG in 0.1 ML InjectionPSNb4434e61-9ec9-4e0e-bd60-45aaa0a87e6412
26308530.1 ML pegcetacoplan 150 MG/ML Injection [Syfovre]SBDb4434e61-9ec9-4e0e-bd60-45aaa0a87e6412
26308470.1 ML pegcetacoplan 150 MG/ML InjectionSCDb4434e61-9ec9-4e0e-bd60-45aaa0a87e6412
26308530.1 ML Syfovre 150 MG/ML InjectionSYb4434e61-9ec9-4e0e-bd60-45aaa0a87e6412
2630847pegcetacoplan 15 MG per 0.1 ML InjectionSYb4434e61-9ec9-4e0e-bd60-45aaa0a87e6412
2630853Syfovre 15 MG per 0.1 ML InjectionSYb4434e61-9ec9-4e0e-bd60-45aaa0a87e6412

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
73606-020-02736060020021 VIAL, GLASS in 1 CARTON (73606-020-02) / 3 mL in 1 VIAL, GLASS2025-11-07NoNoCurrent