Empaveli

Product NDC: 73606-010
11-digit product format: 736060010
Labeler code: 73606
Product ID: 73606-010_a2186f40-2a97-4599-a1a6-e479baa8c1d9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Pegcetacoplan
Dosage form: INJECTION, SOLUTION
Route: SUBCUTANEOUS
Labeler: Apellis Pharmaceuticals, Inc.
Application: NDA215014
Marketing category: NDA
Marketing start: 2021-05-14
Substance: PEGCETACOPLAN
Active strength: 1080 mg/20mL
Pharmacologic classes: Complement Inhibitor [EPC], Complement Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product	73606-010		I	Inactivated by FDA		excluded / ndc_excluded.zip	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	73606-010	73606-010-01	I	Inactivated by FDA		excluded / ndc_excluded.zip	`fb8cb913e6d1…`	`eb8c232b6be0…`

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N215014-001	EMPAVELI	PEGCETACOPLAN	1080MG/20ML (54MG/ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2021-05-14

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
N215014-001	9169307	2027-11-18	U-3123	Drug substance	2021-06-09
N215014-001	9169307	2027-11-18	U-4244	Drug substance	2021-06-09
N215014-001	7888323	2027-12-04		Drug substance	2021-06-09
N215014-001	7989589	2027-12-04		Drug substance	2021-06-09
N215014-001	11661441	2033-01-13	U-3124	Drug substance	2023-06-23
N215014-001	11661441	2033-01-13	U-4242	Drug substance	2023-06-23
N215014-001	10125171	2033-08-02		Drug substance	2021-06-09
N215014-001	10035822	2033-11-15		Drug substance	2021-06-09
N215014-001	10875893	2033-11-15	U-3124	Drug substance	2021-06-09
N215014-001	10875893	2033-11-15	U-4242	Drug substance	2021-06-09
N215014-001	11292815	2033-11-15	U-3124	Drug substance, Drug product	2022-04-29
N215014-001	11292815	2033-11-15	U-3354	Drug substance, Drug product	2022-04-29
N215014-001	11292815	2033-11-15	U-4242	Drug substance, Drug product	2022-04-29
N215014-001	11292815	2033-11-15	U-4243	Drug substance, Drug product	2022-04-29
N215014-001	11040107	2038-04-09	U-3172	Drug product	2021-07-16
N215014-001	11040107	2038-04-09	U-3173	Drug product	2021-07-16
N215014-001	11040107	2038-04-09	U-3174	Drug product	2021-07-16
N215014-001	11040107	2038-04-09	U-4241	Drug product	2021-07-16
N215014-001	11844841	2038-12-09	U-3172	Drug product	2024-01-16
N215014-001	11844841	2038-12-09	U-3173	Drug product	2024-01-16
N215014-001	11844841	2038-12-09	U-3174	Drug product	2024-01-16
N215014-001	11844841	2038-12-09	U-4241	Drug product	2024-01-16
N215014-001	12290566	2038-12-14	U-4174	Drug product	2025-05-07
N215014-001	12290566	2038-12-14	U-4175	Drug product	2025-05-07
N215014-001	12290566	2038-12-14	U-4238	Drug product	2025-05-07
N215014-001	12290566	2038-12-14	U-4239	Drug product	2025-05-07
N215014-001	12290566	2038-12-14	U-4240	Drug product	2025-05-07

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N215014-001	M-288	2026-02-08
N215014-001	NCE	2026-05-14
N215014-001	ODE-351	2028-05-14
N215014-001	I-972	2028-07-28
N215014-001	ODE-533	2032-07-28
N215014-001	ODE-539	2032-07-28

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
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	N215014-001	EMPAVELI	1080MG/20ML (54MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-05-14	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N215014-001	EMPAVELI	1080MG/20ML (54MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-05-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N215014-001	EMPAVELI	1080MG/20ML (54MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-05-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215014-001	EMPAVELI	1080MG/20ML (54MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-05-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215014-001	EMPAVELI	1080MG/20ML (54MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-05-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215014-001	EMPAVELI	1080MG/20ML (54MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-05-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215014-001	EMPAVELI	1080MG/20ML (54MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-05-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215014-001	EMPAVELI	1080MG/20ML (54MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-05-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215014-001	EMPAVELI	1080MG/20ML (54MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-05-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215014-001	EMPAVELI	1080MG/20ML (54MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-05-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215014-001	EMPAVELI	1080MG/20ML (54MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-05-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N215014-001	EMPAVELI	1080MG/20ML (54MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-05-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215014-001	EMPAVELI	1080MG/20ML (54MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-05-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215014-001	EMPAVELI	1080MG/20ML (54MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-05-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N215014-001	EMPAVELI	1080MG/20ML (54MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-05-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N215014-001	EMPAVELI	1080MG/20ML (54MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-05-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N215014-001	EMPAVELI	1080MG/20ML (54MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-05-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N215014-001	EMPAVELI	1080MG/20ML (54MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-05-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N215014-001	EMPAVELI	1080MG/20ML (54MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-05-14	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N215014-001	EMPAVELI	1080MG/20ML (54MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-05-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N215014-001	EMPAVELI	1080MG/20ML (54MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-05-14	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N215014-001	EMPAVELI	1080MG/20ML (54MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-05-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N215014-001	EMPAVELI	1080MG/20ML (54MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-05-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N215014-001	EMPAVELI	1080MG/20ML (54MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-05-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N215014-001	EMPAVELI	1080MG/20ML (54MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-05-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N215014-001	EMPAVELI	1080MG/20ML (54MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-05-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N215014-001	EMPAVELI	1080MG/20ML (54MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-05-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N215014-001	EMPAVELI	1080MG/20ML (54MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-05-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N215014-001	EMPAVELI	1080MG/20ML (54MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-05-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N215014-001	EMPAVELI	1080MG/20ML (54MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-05-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N215014-001	EMPAVELI	1080MG/20ML (54MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-05-14	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N215014-001	EMPAVELI	1080MG/20ML (54MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-05-14	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N215014-001	EMPAVELI	1080MG/20ML (54MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-05-14	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N215014-001	EMPAVELI	1080MG/20ML (54MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-05-14	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N215014-001	EMPAVELI	1080MG/20ML (54MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-05-14	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 13 · 519 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	N215014-001	9169307	2027-11-18	U-4244	Drug substance	2021-06-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215014-001	9169307	2027-11-18	U-3123	Drug substance	2021-06-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215014-001	7888323	2027-12-04		Drug substance	2021-06-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215014-001	7989589	2027-12-04		Drug substance	2021-06-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215014-001	11661441	2033-01-13	U-4242	Drug substance	2023-06-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215014-001	11661441	2033-01-13	U-3124	Drug substance	2023-06-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215014-001	10125171	2033-08-02		Drug substance	2021-06-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215014-001	10035822	2033-11-15		Drug substance	2021-06-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215014-001	10875893	2033-11-15	U-4242	Drug substance	2021-06-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215014-001	10875893	2033-11-15	U-3124	Drug substance	2021-06-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215014-001	11292815	2033-11-15	U-3124	Drug substance, Drug product	2022-04-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215014-001	11292815	2033-11-15	U-3354	Drug substance, Drug product	2022-04-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215014-001	11292815	2033-11-15	U-4242	Drug substance, Drug product	2022-04-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215014-001	11292815	2033-11-15	U-4243	Drug substance, Drug product	2022-04-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215014-001	11040107	2038-04-09	U-3172	Drug product	2021-07-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215014-001	11040107	2038-04-09	U-3174	Drug product	2021-07-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215014-001	11040107	2038-04-09	U-3173	Drug product	2021-07-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215014-001	11040107	2038-04-09	U-4241	Drug product	2021-07-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215014-001	11844841	2038-12-09	U-4241	Drug product	2024-01-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215014-001	11844841	2038-12-09	U-3172	Drug product	2024-01-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215014-001	11844841	2038-12-09	U-3174	Drug product	2024-01-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215014-001	11844841	2038-12-09	U-3173	Drug product	2024-01-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215014-001	12290566	2038-12-14	U-4174	Drug product	2025-05-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215014-001	12290566	2038-12-14	U-4175	Drug product	2025-05-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215014-001	12290566	2038-12-14	U-4239	Drug product	2025-05-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215014-001	12290566	2038-12-14	U-4238	Drug product	2025-05-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215014-001	12290566	2038-12-14	U-4240	Drug product	2025-05-07	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N215014-001	9169307	2027-11-18	U-4244	Drug substance	2021-06-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215014-001	9169307	2027-11-18	U-3123	Drug substance	2021-06-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215014-001	7888323	2027-12-04		Drug substance	2021-06-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215014-001	7989589	2027-12-04		Drug substance	2021-06-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215014-001	11661441	2033-01-13	U-4242	Drug substance	2023-06-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215014-001	11661441	2033-01-13	U-3124	Drug substance	2023-06-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215014-001	10125171	2033-08-02		Drug substance	2021-06-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215014-001	10035822	2033-11-15		Drug substance	2021-06-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215014-001	10875893	2033-11-15	U-4242	Drug substance	2021-06-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215014-001	10875893	2033-11-15	U-3124	Drug substance	2021-06-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215014-001	11292815	2033-11-15	U-3124	Drug substance, Drug product	2022-04-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215014-001	11292815	2033-11-15	U-3354	Drug substance, Drug product	2022-04-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215014-001	11292815	2033-11-15	U-4242	Drug substance, Drug product	2022-04-29	`caaa826d4ba7…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 3 · 106 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	N215014-001	M-288	2026-02-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215014-001	NCE	2026-05-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215014-001	ODE-351	2028-05-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215014-001	I-972	2028-07-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215014-001	ODE-533	2032-07-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215014-001	ODE-539	2032-07-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N215014-001	M-288	2026-02-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215014-001	NCE	2026-05-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215014-001	ODE-351	2028-05-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215014-001	I-972	2028-07-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215014-001	ODE-533	2032-07-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215014-001	ODE-539	2032-07-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N215014-001	M-288	2026-02-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215014-001	NCE	2026-05-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215014-001	ODE-351	2028-05-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215014-001	I-972	2028-07-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215014-001	M-288	2026-02-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215014-001	NCE	2026-05-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215014-001	ODE-351	2028-05-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215014-001	I-972	2028-07-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215014-001	M-288	2026-02-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215014-001	NCE	2026-05-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215014-001	ODE-351	2028-05-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215014-001	M-288	2026-02-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215014-001	NCE	2026-05-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215014-001	ODE-351	2028-05-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215014-001	M-288	2026-02-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215014-001	NCE	2026-05-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215014-001	ODE-351	2028-05-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215014-001	M-288	2026-02-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215014-001	NCE	2026-05-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215014-001	ODE-351	2028-05-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215014-001	M-288	2026-02-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215014-001	NCE	2026-05-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215014-001	ODE-351	2028-05-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215014-001	M-288	2026-02-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215014-001	NCE	2026-05-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215014-001	ODE-351	2028-05-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215014-001	M-288	2026-02-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215014-001	NCE	2026-05-14	`d8e5a09893c0…`

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: Empaveli
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PEGCETACOPLAN	1080 mg/20mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
TO3JYR3BOU	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2557386	Internal RxNorm lookup
2557391	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
c23d89e9-b00b-4520-e053-2995a90a95af	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
da70f326-eccc-4ddc-93bb-212c53d94fc7	Product name	1	20231002
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
d1a4c427-3368-4f7b-a9d9-d408ab477de6	Product name	1	20211208
48747306-602a-42cc-957b-5b0c69158eee	Product name	1	20180604
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578b	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2023-02-21	These highlights do not include all the information needed to use EMPAVELI safely and effectively. See full prescribing information for EMPAVELI. EMPAVELI ® (pegcetacoplan) injection, for subcutaneous use Initial U.S. Approval: 2021
2023-02-21	These highlights do not include all the information needed to use EMPAVELI safely and effectively. See full prescribing information for EMPAVELI. EMPAVELI ® (pegcetacoplan) injection, for subcutaneous use Initial U.S. Approval: 2021
2022-07-29	These highlights do not include all the information needed to use EMPAVELI safely and effectively. See full prescribing information for EMPAVELI. EMPAVELI ® (pegcetacoplan) injection, for subcutaneous use Initial U.S. Approval: 2021
2022-07-29	These highlights do not include all the information needed to use EMPAVELI safely and effectively. See full prescribing information for EMPAVELI. EMPAVELI ® (pegcetacoplan) injection, for subcutaneous use Initial U.S. Approval: 2021

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
73606-010-01	Empaveli	1 in 1 CARTON	INJECTION, SOLUTION	1		13
73606-010-01	Empaveli	20 mL in 1 VIAL	INJECTION, SOLUTION	20		13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
73606-010-01	ML - Milliliter	73606-010	963e1fde-3fca-4a08-9ee3-aff710a58bf4	1	2021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
73606-010	EMPAVELI (PEGCETACOPLAN) INJECTION, SOLUTION [APELLIS PHARMACEUTICALS, INC.]	11	Current NDC, Legacy NDC, 2 package rows	20250109_c23d89e9-b00b-4520-e053-2995a90a95af.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
Empaveli	PEGCETACOPLAN	Apellis Pharmaceuticals, Inc.	c23d89e9-b00b-4520-e053-2995a90a95af	2026-08-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 215014 application number: NDA215014 ndc (product): 73606-010

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
TO3JYR3BOU	PEGCETACOPLAN	2019171-69-6	PEGCETACOPLAN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2557391	EMPAVELI 1080 MG in 20 ML Injection	PSN	c23d89e9-b00b-4520-e053-2995a90a95af	13
2557386	pegcetacoplan 1080 MG in 20 ML Injection	PSN	c23d89e9-b00b-4520-e053-2995a90a95af	13
2557391	20 ML pegcetacoplan 54 MG/ML Injection [Empaveli]	SBD	c23d89e9-b00b-4520-e053-2995a90a95af	13
2557386	20 ML pegcetacoplan 54 MG/ML Injection	SCD	c23d89e9-b00b-4520-e053-2995a90a95af	13
2557391	20 ML Empaveli 54 MG/ML Injection	SY	c23d89e9-b00b-4520-e053-2995a90a95af	13
2557391	Empaveli 1080 MG per 20 ML Injection	SY	c23d89e9-b00b-4520-e053-2995a90a95af	13
2557386	pegcetacoplan 1080 MG per 20 ML Injection	SY	c23d89e9-b00b-4520-e053-2995a90a95af	13

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
73606-010-01	73606001001	1 VIAL in 1 CARTON (73606-010-01) / 20 mL in 1 VIAL	1 vial	2021-05-14	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Empaveli	Apellis Pharmaceuticals, Inc. \| Juzen Chemical Corporation \| Bachem AG \| Eurofins Lancaster Laboratories, LLC \| Eurofins Advantar Laboratories, LLC \| Bora Pharmaceuticals Injectables Inc. \| Nelson Laboratories, LLC \| AndersonBrecon Inc \| Cenexi HSC	2026-08-21	HUMAN PRESCRIPTION DRUG LABEL	14