ZILBRYSQ

Product NDC: 50474-991
Requested package NDC: 50474-991-80
11-digit product format: 504740991
Labeler code: 50474
Product ID: 50474-991_49eeeabf-4c62-63cb-e063-6394a90a8248
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 43.

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 · 63 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 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…`
2024-10-29 15:01 UTC	2024-10	N216834-002	ZILBRYSQ	EQ 23MG BASE/0.574ML (EQ 23MG BASE/0.574ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-10-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N216834-003	ZILBRYSQ	EQ 32.4MG BASE/0.81ML (EQ 32.4 BASE/0.81ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-10-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N216834-001	ZILBRYSQ	EQ 16.6MG BASE/0.416ML (EQ 16.6MG BASE/0.416ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-10-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N216834-002	ZILBRYSQ	EQ 23MG BASE/0.574ML (EQ 23MG BASE/0.574ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-10-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N216834-003	ZILBRYSQ	EQ 32.4MG BASE/0.81ML (EQ 32.4 BASE/0.81ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-10-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N216834-001	ZILBRYSQ	EQ 16.6MG BASE/0.416ML (EQ 16.6MG BASE/0.416ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-10-17	`301d65b070ca…`

Observed Orange Book patent history#

Patent history page 1 of 14 · 528 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N216834-001	10106579	2035-06-12	U-3735	Drug substance, Drug product	2023-11-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216834-001	10208089	2035-06-12	U-3735	Drug substance	2023-11-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216834-001	10435438	2035-06-12	U-3735	Drug substance	2023-11-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216834-001	10562934	2035-06-12		Drug substance	2023-11-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216834-001	10835574	2035-06-12		Drug product	2023-11-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216834-001	11014965	2035-06-12	U-3735	Drug substance	2023-11-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216834-001	11535650	2035-06-12		Drug product	2023-11-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216834-001	11752190	2035-06-12	U-3735	Drug product	2023-11-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216834-001	11965040	2035-06-12		Drug product	2024-05-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216834-002	10106579	2035-06-12	U-3735	Drug substance, Drug product	2023-11-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216834-002	10208089	2035-06-12	U-3735	Drug substance	2023-11-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216834-002	10435438	2035-06-12	U-3735	Drug substance	2023-11-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216834-002	10562934	2035-06-12		Drug substance	2023-11-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216834-002	10835574	2035-06-12		Drug product	2023-11-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216834-002	11014965	2035-06-12	U-3735	Drug substance	2023-11-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216834-002	11535650	2035-06-12		Drug product	2023-11-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216834-002	11752190	2035-06-12	U-3735	Drug product	2023-11-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216834-002	11965040	2035-06-12		Drug product	2024-05-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216834-003	10106579	2035-06-12	U-3735	Drug substance, Drug product	2023-11-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216834-003	10208089	2035-06-12	U-3735	Drug substance	2023-11-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216834-003	10435438	2035-06-12	U-3735	Drug substance	2023-11-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216834-003	10562934	2035-06-12		Drug substance	2023-11-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216834-003	10835574	2035-06-12		Drug product	2023-11-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216834-003	11014965	2035-06-12	U-3735	Drug substance	2023-11-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216834-003	11535650	2035-06-12		Drug product	2023-11-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216834-003	11752190	2035-06-12	U-3735	Drug product	2023-11-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216834-003	11965040	2035-06-12		Drug product	2024-05-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N216834-001	10106579	2035-06-12	U-3735	Drug substance, Drug product	2023-11-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216834-001	10208089	2035-06-12	U-3735	Drug substance	2023-11-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216834-001	10435438	2035-06-12	U-3735	Drug substance	2023-11-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216834-001	10562934	2035-06-12		Drug substance	2023-11-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216834-001	10835574	2035-06-12		Drug product	2023-11-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216834-001	11014965	2035-06-12	U-3735	Drug substance	2023-11-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216834-001	11535650	2035-06-12		Drug product	2023-11-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216834-001	11752190	2035-06-12	U-3735	Drug product	2023-11-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216834-001	11965040	2035-06-12		Drug product	2024-05-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216834-002	10106579	2035-06-12	U-3735	Drug substance, Drug product	2023-11-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216834-002	10208089	2035-06-12	U-3735	Drug substance	2023-11-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216834-002	10435438	2035-06-12	U-3735	Drug substance	2023-11-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216834-002	10562934	2035-06-12		Drug substance	2023-11-13	`caaa826d4ba7…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 3 · 120 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
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…`
2025-08-23 18:47 UTC	2025-08	N216834-003	NCE	2028-10-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216834-003	ODE-446	2030-10-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216834-001	NCE	2028-10-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216834-001	ODE-446	2030-10-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216834-002	NCE	2028-10-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216834-002	ODE-446	2030-10-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216834-003	NCE	2028-10-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216834-003	ODE-446	2030-10-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216834-001	NCE	2028-10-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216834-001	ODE-446	2030-10-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216834-002	NCE	2028-10-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216834-002	ODE-446	2030-10-17	`b8a1b40f171c…`

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
YG391PK0CC	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2672496	Internal RxNorm lookup
2672502	Internal RxNorm lookup
2672504	Internal RxNorm lookup
2672505	Internal RxNorm lookup
2672506	Internal RxNorm lookup
2672507	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
9f1d53d6-e495-4a3a-8bb9-680a15d25034	Available on FDA.report

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
50474-991-80	ZILBRYSQ	7 in 1 CARTON	INJECTION, SOLUTION	7		13
50474-991-80	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
50474-991-80	ML - Milliliter	50474-991	7dc5b9c5-2329-4916-86fb-cf464b190de9	1	2024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50474-991	ZILBRYSQ (ZILUCOPLAN) INJECTION, SOLUTION [UCB, INC.]	11	Current NDC, 2 package rows	20250316_9f1d53d6-e495-4a3a-8bb9-680a15d25034.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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ZILBRYSQ	ZILUCOPLAN	UCB, Inc.	9f1d53d6-e495-4a3a-8bb9-680a15d25034	2026-02-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 216834 application number: NDA216834 ndc (package): 50474-991-80 ndc (product): 50474-991 ndc11 (package): 50474099180

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
50474-991-80	50474099180	4 CARTON in 1 BOX (50474-991-80) / 7 SYRINGE, GLASS in 1 CARTON / .574 mL in 1 SYRINGE, GLASS	4 carton	2024-01-03	No	No	Current