ZILBRYSQ

Product NDC: 50474-992
11-digit product format: 504740992
Labeler code: 50474
Product ID: 50474-992_5eeb3dd7-71e1-9b0c-e063-6394a90a5cc8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: zilucoplan
Dosage form: INJECTION, SOLUTION
Route: SUBCUTANEOUS
Labeler: UCB, Inc.
Application: NDA216834
Marketing category: NDA
Marketing start: 2024-01-03
Substance: ZILUCOPLAN
Active strength: 40 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 45.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N216834-001	ZILBRYSQ	ZILUCOPLAN SODIUM	EQ 16.6MG BASE/0.416ML (EQ 16.6MG BASE/0.416ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-10-17
N216834-002	ZILBRYSQ	ZILUCOPLAN SODIUM	EQ 23MG BASE/0.574ML (EQ 23MG BASE/0.574ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-10-17
N216834-003	ZILBRYSQ	ZILUCOPLAN SODIUM	EQ 32.4MG BASE/0.81ML (EQ 32.4 BASE/0.81ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-10-17

Orange Book patents#

Current patent rows page 1 of 1 · 27 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N216834-001	10106579	2035-06-12	U-3735	Drug substance, Drug product	2023-11-13
N216834-001	10208089	2035-06-12	U-3735	Drug substance	2023-11-13
N216834-001	10435438	2035-06-12	U-3735	Drug substance	2023-11-13
N216834-001	10562934	2035-06-12		Drug substance	2023-11-13
N216834-001	10835574	2035-06-12		Drug product	2023-11-13
N216834-001	11014965	2035-06-12	U-3735	Drug substance	2023-11-13
N216834-001	11535650	2035-06-12		Drug product	2023-11-13
N216834-001	11752190	2035-06-12	U-3735	Drug product	2023-11-13
N216834-001	11965040	2035-06-12		Drug product	2024-05-17
N216834-002	10106579	2035-06-12	U-3735	Drug substance, Drug product	2023-11-13
N216834-002	10208089	2035-06-12	U-3735	Drug substance	2023-11-13
N216834-002	10435438	2035-06-12	U-3735	Drug substance	2023-11-13
N216834-002	10562934	2035-06-12		Drug substance	2023-11-13
N216834-002	10835574	2035-06-12		Drug product	2023-11-13
N216834-002	11014965	2035-06-12	U-3735	Drug substance	2023-11-13
N216834-002	11535650	2035-06-12		Drug product	2023-11-13
N216834-002	11752190	2035-06-12	U-3735	Drug product	2023-11-13
N216834-002	11965040	2035-06-12		Drug product	2024-05-17
N216834-003	10106579	2035-06-12	U-3735	Drug substance, Drug product	2023-11-13
N216834-003	10208089	2035-06-12	U-3735	Drug substance	2023-11-13
N216834-003	10435438	2035-06-12	U-3735	Drug substance	2023-11-13
N216834-003	10562934	2035-06-12		Drug substance	2023-11-13
N216834-003	10835574	2035-06-12		Drug product	2023-11-13
N216834-003	11014965	2035-06-12	U-3735	Drug substance	2023-11-13
N216834-003	11535650	2035-06-12		Drug product	2023-11-13
N216834-003	11752190	2035-06-12	U-3735	Drug product	2023-11-13
N216834-003	11965040	2035-06-12		Drug product	2024-05-17

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N216834-001	NCE	2028-10-17
N216834-001	ODE-446	2030-10-17
N216834-002	NCE	2028-10-17
N216834-002	ODE-446	2030-10-17
N216834-003	NCE	2028-10-17
N216834-003	ODE-446	2030-10-17

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.

Product history page 1 of 2 · 69 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-11-14 07:37:17	2026-10	N216834-001	ZILBRYSQ	EQ 16.6MG BASE/0.416ML (EQ 16.6MG BASE/0.416ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-10-17	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N216834-002	ZILBRYSQ	EQ 23MG BASE/0.574ML (EQ 23MG BASE/0.574ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-10-17	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N216834-003	ZILBRYSQ	EQ 32.4MG BASE/0.81ML (EQ 32.4 BASE/0.81ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-10-17	`d4dbc9d85df4…`
2026-10-15 13:18:30	2026-09	N216834-001	ZILBRYSQ	EQ 16.6MG BASE/0.416ML (EQ 16.6MG BASE/0.416ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-10-17	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216834-002	ZILBRYSQ	EQ 23MG BASE/0.574ML (EQ 23MG BASE/0.574ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-10-17	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216834-003	ZILBRYSQ	EQ 32.4MG BASE/0.81ML (EQ 32.4 BASE/0.81ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-10-17	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N216834-001	ZILBRYSQ	EQ 16.6MG BASE/0.416ML (EQ 16.6MG BASE/0.416ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-10-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216834-002	ZILBRYSQ	EQ 23MG BASE/0.574ML (EQ 23MG BASE/0.574ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-10-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216834-003	ZILBRYSQ	EQ 32.4MG BASE/0.81ML (EQ 32.4 BASE/0.81ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-10-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N216834-001	ZILBRYSQ	EQ 16.6MG BASE/0.416ML (EQ 16.6MG BASE/0.416ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-10-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216834-002	ZILBRYSQ	EQ 23MG BASE/0.574ML (EQ 23MG BASE/0.574ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-10-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216834-003	ZILBRYSQ	EQ 32.4MG BASE/0.81ML (EQ 32.4 BASE/0.81ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-10-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N216834-001	ZILBRYSQ	EQ 16.6MG BASE/0.416ML (EQ 16.6MG BASE/0.416ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-10-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216834-002	ZILBRYSQ	EQ 23MG BASE/0.574ML (EQ 23MG BASE/0.574ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-10-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216834-003	ZILBRYSQ	EQ 32.4MG BASE/0.81ML (EQ 32.4 BASE/0.81ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-10-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216834-001	ZILBRYSQ	EQ 16.6MG BASE/0.416ML (EQ 16.6MG BASE/0.416ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-10-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216834-002	ZILBRYSQ	EQ 23MG BASE/0.574ML (EQ 23MG BASE/0.574ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-10-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216834-003	ZILBRYSQ	EQ 32.4MG BASE/0.81ML (EQ 32.4 BASE/0.81ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-10-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N216834-001	ZILBRYSQ	EQ 16.6MG BASE/0.416ML (EQ 16.6MG BASE/0.416ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-10-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216834-002	ZILBRYSQ	EQ 23MG BASE/0.574ML (EQ 23MG BASE/0.574ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-10-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216834-003	ZILBRYSQ	EQ 32.4MG BASE/0.81ML (EQ 32.4 BASE/0.81ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-10-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216834-001	ZILBRYSQ	EQ 16.6MG BASE/0.416ML (EQ 16.6MG BASE/0.416ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-10-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216834-002	ZILBRYSQ	EQ 23MG BASE/0.574ML (EQ 23MG BASE/0.574ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-10-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216834-003	ZILBRYSQ	EQ 32.4MG BASE/0.81ML (EQ 32.4 BASE/0.81ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-10-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216834-001	ZILBRYSQ	EQ 16.6MG BASE/0.416ML (EQ 16.6MG BASE/0.416ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-10-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216834-002	ZILBRYSQ	EQ 23MG BASE/0.574ML (EQ 23MG BASE/0.574ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-10-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216834-003	ZILBRYSQ	EQ 32.4MG BASE/0.81ML (EQ 32.4 BASE/0.81ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-10-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216834-001	ZILBRYSQ	EQ 16.6MG BASE/0.416ML (EQ 16.6MG BASE/0.416ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-10-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216834-002	ZILBRYSQ	EQ 23MG BASE/0.574ML (EQ 23MG BASE/0.574ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-10-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216834-003	ZILBRYSQ	EQ 32.4MG BASE/0.81ML (EQ 32.4 BASE/0.81ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-10-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216834-001	ZILBRYSQ	EQ 16.6MG BASE/0.416ML (EQ 16.6MG BASE/0.416ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-10-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216834-002	ZILBRYSQ	EQ 23MG BASE/0.574ML (EQ 23MG BASE/0.574ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-10-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216834-003	ZILBRYSQ	EQ 32.4MG BASE/0.81ML (EQ 32.4 BASE/0.81ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-10-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N216834-001	ZILBRYSQ	EQ 16.6MG BASE/0.416ML (EQ 16.6MG BASE/0.416ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-10-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N216834-002	ZILBRYSQ	EQ 23MG BASE/0.574ML (EQ 23MG BASE/0.574ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-10-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N216834-003	ZILBRYSQ	EQ 32.4MG BASE/0.81ML (EQ 32.4 BASE/0.81ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-10-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N216834-001	ZILBRYSQ	EQ 16.6MG BASE/0.416ML (EQ 16.6MG BASE/0.416ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-10-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N216834-002	ZILBRYSQ	EQ 23MG BASE/0.574ML (EQ 23MG BASE/0.574ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-10-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N216834-003	ZILBRYSQ	EQ 32.4MG BASE/0.81ML (EQ 32.4 BASE/0.81ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-10-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N216834-001	ZILBRYSQ	EQ 16.6MG BASE/0.416ML (EQ 16.6MG BASE/0.416ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-10-17	`d06236e962d9…`

Observed Orange Book patent history#

Patent history page 1 of 15 · 582 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-11-14 07:37:17	2026-10	N216834-001	10106579	2035-06-12	U-3735	Drug substance, Drug product	2023-11-13	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N216834-001	10208089	2035-06-12	U-3735	Drug substance	2023-11-13	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N216834-001	10435438	2035-06-12	U-3735	Drug substance	2023-11-13	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N216834-001	10562934	2035-06-12		Drug substance	2023-11-13	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N216834-001	10835574	2035-06-12		Drug product	2023-11-13	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N216834-001	11014965	2035-06-12	U-3735	Drug substance	2023-11-13	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N216834-001	11535650	2035-06-12		Drug product	2023-11-13	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N216834-001	11752190	2035-06-12	U-3735	Drug product	2023-11-13	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N216834-001	11965040	2035-06-12		Drug product	2024-05-17	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N216834-002	10106579	2035-06-12	U-3735	Drug substance, Drug product	2023-11-13	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N216834-002	10208089	2035-06-12	U-3735	Drug substance	2023-11-13	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N216834-002	10435438	2035-06-12	U-3735	Drug substance	2023-11-13	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N216834-002	10562934	2035-06-12		Drug substance	2023-11-13	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N216834-002	10835574	2035-06-12		Drug product	2023-11-13	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N216834-002	11014965	2035-06-12	U-3735	Drug substance	2023-11-13	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N216834-002	11535650	2035-06-12		Drug product	2023-11-13	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N216834-002	11752190	2035-06-12	U-3735	Drug product	2023-11-13	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N216834-002	11965040	2035-06-12		Drug product	2024-05-17	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N216834-003	10106579	2035-06-12	U-3735	Drug substance, Drug product	2023-11-13	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N216834-003	10208089	2035-06-12	U-3735	Drug substance	2023-11-13	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N216834-003	10435438	2035-06-12	U-3735	Drug substance	2023-11-13	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N216834-003	10562934	2035-06-12		Drug substance	2023-11-13	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N216834-003	10835574	2035-06-12		Drug product	2023-11-13	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N216834-003	11014965	2035-06-12	U-3735	Drug substance	2023-11-13	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N216834-003	11535650	2035-06-12		Drug product	2023-11-13	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N216834-003	11752190	2035-06-12	U-3735	Drug product	2023-11-13	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N216834-003	11965040	2035-06-12		Drug product	2024-05-17	`d4dbc9d85df4…`
2026-10-15 13:18:30	2026-09	N216834-001	10106579	2035-06-12	U-3735	Drug substance, Drug product	2023-11-13	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216834-001	10208089	2035-06-12	U-3735	Drug substance	2023-11-13	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216834-001	10435438	2035-06-12	U-3735	Drug substance	2023-11-13	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216834-001	10562934	2035-06-12		Drug substance	2023-11-13	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216834-001	10835574	2035-06-12		Drug product	2023-11-13	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216834-001	11014965	2035-06-12	U-3735	Drug substance	2023-11-13	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216834-001	11535650	2035-06-12		Drug product	2023-11-13	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216834-001	11752190	2035-06-12	U-3735	Drug product	2023-11-13	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216834-001	11965040	2035-06-12		Drug product	2024-05-17	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216834-002	10106579	2035-06-12	U-3735	Drug substance, Drug product	2023-11-13	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216834-002	10208089	2035-06-12	U-3735	Drug substance	2023-11-13	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216834-002	10435438	2035-06-12	U-3735	Drug substance	2023-11-13	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216834-002	10562934	2035-06-12		Drug substance	2023-11-13	`c2088c7a36db…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-11-14 07:37:17	2026-10	N216834-001	NCE	2028-10-17	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N216834-001	ODE-446	2030-10-17	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N216834-002	NCE	2028-10-17	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N216834-002	ODE-446	2030-10-17	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N216834-003	NCE	2028-10-17	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N216834-003	ODE-446	2030-10-17	`d4dbc9d85df4…`
2026-10-15 13:18:30	2026-09	N216834-001	NCE	2028-10-17	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216834-001	ODE-446	2030-10-17	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216834-002	NCE	2028-10-17	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216834-002	ODE-446	2030-10-17	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216834-003	NCE	2028-10-17	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216834-003	ODE-446	2030-10-17	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N216834-001	NCE	2028-10-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216834-001	ODE-446	2030-10-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216834-002	NCE	2028-10-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216834-002	ODE-446	2030-10-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216834-003	NCE	2028-10-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216834-003	ODE-446	2030-10-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N216834-001	NCE	2028-10-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216834-001	ODE-446	2030-10-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216834-002	NCE	2028-10-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216834-002	ODE-446	2030-10-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216834-003	NCE	2028-10-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216834-003	ODE-446	2030-10-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N216834-001	NCE	2028-10-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216834-001	ODE-446	2030-10-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216834-002	NCE	2028-10-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216834-002	ODE-446	2030-10-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216834-003	NCE	2028-10-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216834-003	ODE-446	2030-10-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216834-001	NCE	2028-10-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216834-001	ODE-446	2030-10-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216834-002	NCE	2028-10-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216834-002	ODE-446	2030-10-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216834-003	NCE	2028-10-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216834-003	ODE-446	2030-10-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N216834-001	NCE	2028-10-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216834-001	ODE-446	2030-10-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216834-002	NCE	2028-10-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216834-002	ODE-446	2030-10-17	`6a471c1ec25d…`

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: ZILBRYSQ
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ZILUCOPLAN	40 mg/mL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d5017567-4b89-47d2-9d4f-3fe2e6641b4d	Product name	1	20250630
726062af-1135-4707-a1d7-57256991bbf9	Product name	2	20250226
19c71a3d-ed9c-166b-a7e5-38c250c35631	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50474-992-80	ZILBRYSQ	7 in 1 CARTON	INJECTION, SOLUTION	7		13
50474-992-80	ZILBRYSQ	4 in 1 BOX	INJECTION, SOLUTION	4		13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50474-992-80	ML - Milliliter	50474-992	b970d281-d2bf-4731-86cd-03e58e647748	1	2024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50474-992	ZILBRYSQ (ZILUCOPLAN) INJECTION, SOLUTION [UCB, INC.]	11	Current NDC, 2 package rows	20250316_9f1d53d6-e495-4a3a-8bb9-680a15d25034.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
YG391PK0CC	ZILUCOPLAN	1841136-73-9	ZILUCOPLAN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2672502	ZILBRYSQ 16.6 MG in 0.416 ML Prefilled Syringe	PSN	9f1d53d6-e495-4a3a-8bb9-680a15d25034	13
2672505	ZILBRYSQ 23 MG in 0.574 ML Prefilled Syringe	PSN	9f1d53d6-e495-4a3a-8bb9-680a15d25034	13
2672507	ZILBRYSQ 32.4 MG in 0.81 ML Prefilled Syringe	PSN	9f1d53d6-e495-4a3a-8bb9-680a15d25034	13
2672496	zilucoplan 16.6 MG in 0.416 ML Prefilled Syringe	PSN	9f1d53d6-e495-4a3a-8bb9-680a15d25034	13
2672504	zilucoplan 23 MG in 0.574 ML Prefilled Syringe	PSN	9f1d53d6-e495-4a3a-8bb9-680a15d25034	13
2672506	zilucoplan 32.4 MG in 0.81 ML Prefilled Syringe	PSN	9f1d53d6-e495-4a3a-8bb9-680a15d25034	13
2672502	0.416 ML zilucoplan 40 MG/ML Prefilled Syringe [Zilbrysq]	SBD	9f1d53d6-e495-4a3a-8bb9-680a15d25034	13
2672505	0.574 ML zilucoplan 40 MG/ML Prefilled Syringe [Zilbrysq]	SBD	9f1d53d6-e495-4a3a-8bb9-680a15d25034	13
2672507	0.81 ML zilucoplan 40 MG/ML Prefilled Syringe [Zilbrysq]	SBD	9f1d53d6-e495-4a3a-8bb9-680a15d25034	13
2672496	0.416 ML zilucoplan 40 MG/ML Prefilled Syringe	SCD	9f1d53d6-e495-4a3a-8bb9-680a15d25034	13
2672504	0.574 ML zilucoplan 40 MG/ML Prefilled Syringe	SCD	9f1d53d6-e495-4a3a-8bb9-680a15d25034	13
2672506	0.81 ML zilucoplan 40 MG/ML Prefilled Syringe	SCD	9f1d53d6-e495-4a3a-8bb9-680a15d25034	13
2672502	Zilbrysq 16.6 MG (equivalent to zilucoplan sodium 17 MG) per 0.416 ML Prefilled Syringe	SY	9f1d53d6-e495-4a3a-8bb9-680a15d25034	13
2672505	Zilbrysq 23 MG (equivalent to zilucoplan sodium 23.6 MG) per 0.574 ML Prefilled Syringe	SY	9f1d53d6-e495-4a3a-8bb9-680a15d25034	13
2672507	Zilbrysq 32.4 MG (equivalent to zilucoplan sodium 33.2 MG) per 0.81 ML Prefilled Syringe	SY	9f1d53d6-e495-4a3a-8bb9-680a15d25034	13
2672496	zilucoplan 16.6 MG (equivalent to zilucoplan sodium 17 MG) per 0.416 ML Prefilled Syringe	SY	9f1d53d6-e495-4a3a-8bb9-680a15d25034	13
2672504	zilucoplan 23 MG (equivalent to zilucoplan sodium 23.6 MG) per 0.574 ML Prefilled Syringe	SY	9f1d53d6-e495-4a3a-8bb9-680a15d25034	13
2672506	zilucoplan 32.4 MG (equivalent to zilucoplan sodium 33.2 MG) per 0.81 ML Prefilled Syringe	SY	9f1d53d6-e495-4a3a-8bb9-680a15d25034	13

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
50474-992-80	50474099280	4 CARTON in 1 BOX (50474-992-80) / 7 SYRINGE, GLASS in 1 CARTON / .81 mL in 1 SYRINGE, GLASS	4 carton	2024-01-03	No	No	Current