Imcivree

Product NDC: 72829-010
Requested package NDC: 72829-010-01
11-digit product format: 728290010
Labeler code: 72829
Product ID: 72829-010_4e69249c-b81d-8559-e063-6294a90adbc2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: setmelanotide
Dosage form: SOLUTION
Route: SUBCUTANEOUS
Labeler: Rhythm Pharmaceuticals, Inc
Application: NDA213793
Marketing category: NDA
Marketing start: 2020-12-14
Substance: SETMELANOTIDE
Active strength: 10 mg/mL
Pharmacologic classes: Melanocortin 4 Receptor Agonist [EPC], Melanocortin 4 Receptor Agonists [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 · 9 matching rows.

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

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-04-01 02:39 UTC · source 2025-03-31	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2022-04-09 23:13 UTC · source 2022-04-08	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N213793-001	IMCIVREE	SETMELANOTIDE ACETATE	EQ 10MG BASE/ML (EQ 10MG BASE/ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2020-11-25

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Coverage / status	Submission date
N213793-001	9458195	2027-10-13	Drug substance, Drug product	2020-12-22
N213793-001	8039435	2032-08-21	Drug substance, Drug product	2020-12-22
N213793-001	11129869	2034-07-04	Drug product	2021-10-25

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N213793-001	ODE-336	2027-11-25
N213793-001	NPP	2027-12-20
N213793-001	I-987	2029-03-19
N213793-001	ODE-402	2029-06-16
N213793-001	ODE-508	2031-12-20
N213793-001	ODE-509	2031-12-20

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
2026-02-19 14:30 UTC	2026-02	N213793-001	IMCIVREE	EQ 10MG BASE/ML (EQ 10MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2020-11-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213793-001	IMCIVREE	EQ 10MG BASE/ML (EQ 10MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2020-11-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N213793-001	IMCIVREE	EQ 10MG BASE/ML (EQ 10MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2020-11-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213793-001	IMCIVREE	EQ 10MG BASE/ML (EQ 10MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2020-11-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213793-001	IMCIVREE	EQ 10MG BASE/ML (EQ 10MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2020-11-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213793-001	IMCIVREE	EQ 10MG BASE/ML (EQ 10MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2020-11-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213793-001	IMCIVREE	EQ 10MG BASE/ML (EQ 10MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2020-11-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213793-001	IMCIVREE	EQ 10MG BASE/ML (EQ 10MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2020-11-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213793-001	IMCIVREE	EQ 10MG BASE/ML (EQ 10MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2020-11-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N213793-001	IMCIVREE	EQ 10MG BASE/ML (EQ 10MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2020-11-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N213793-001	IMCIVREE	EQ 10MG BASE/ML (EQ 10MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2020-11-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N213793-001	IMCIVREE	EQ 10MG BASE/ML (EQ 10MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2020-11-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N213793-001	IMCIVREE	EQ 10MG BASE/ML (EQ 10MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2020-11-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N213793-001	IMCIVREE	EQ 10MG BASE/ML (EQ 10MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2020-11-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N213793-001	IMCIVREE	EQ 10MG/ML BASE (EQ 10MG/ML BASE)	SOLUTION / SUBCUTANEOUS	RLD, RS	2020-11-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N213793-001	IMCIVREE	EQ 10MG/ML BASE (EQ 10MG/ML BASE)	SOLUTION / SUBCUTANEOUS	RLD, RS	2020-11-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N213793-001	IMCIVREE	EQ 10MG/ML BASE (EQ 10MG/ML BASE)	SOLUTION / SUBCUTANEOUS	RLD, RS	2020-11-25	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N213793-001	IMCIVREE	EQ 10MG/ML BASE (EQ 10MG/ML BASE)	SOLUTION / SUBCUTANEOUS	RLD, RS	2020-11-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N213793-001	IMCIVREE	EQ 10MG/ML BASE (EQ 10MG/ML BASE)	SOLUTION / SUBCUTANEOUS	RLD, RS	2020-11-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N213793-001	IMCIVREE	EQ 10MG/ML BASE (EQ 10MG/ML BASE)	SOLUTION / SUBCUTANEOUS	RLD, RS	2020-11-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N213793-001	IMCIVREE	EQ 10MG/ML BASE (EQ 10MG/ML BASE)	SOLUTION / SUBCUTANEOUS	RLD, RS	2020-11-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N213793-001	IMCIVREE	EQ 10MG/ML BASE (EQ 10MG/ML BASE)	SOLUTION / SUBCUTANEOUS	RLD, RS	2020-11-25	`8869cabd3fbd…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N213793-001	IMCIVREE	EQ 10MG BASE/ML (EQ 10MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2020-11-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N213793-001	IMCIVREE	EQ 10MG BASE/ML (EQ 10MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2020-11-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N213793-001	IMCIVREE	EQ 10MG BASE/ML (EQ 10MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2020-11-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N213793-001	IMCIVREE	EQ 10MG BASE/ML (EQ 10MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2020-11-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N213793-001	IMCIVREE	EQ 10MG BASE/ML (EQ 10MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2020-11-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N213793-001	IMCIVREE	EQ 10MG/ML BASE (EQ 10MG/ML BASE)	SOLUTION / SUBCUTANEOUS	RLD, RS	2020-11-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N213793-001	IMCIVREE	EQ 10MG/ML BASE (EQ 10MG/ML BASE)	SOLUTION / SUBCUTANEOUS	RLD, RS	2020-11-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N213793-001	IMCIVREE	EQ 10MG/ML BASE (EQ 10MG/ML BASE)	SOLUTION / SUBCUTANEOUS	RLD, RS	2020-11-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N213793-001	IMCIVREE	EQ 10MG/ML BASE (EQ 10MG/ML BASE)	SOLUTION / SUBCUTANEOUS	RLD, RS	2020-11-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N213793-001	IMCIVREE	EQ 10MG/ML BASE (EQ 10MG/ML BASE)	SOLUTION / SUBCUTANEOUS	RLD, RS	2020-11-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N213793-001	IMCIVREE	EQ 10MG/ML BASE (EQ 10MG/ML BASE)	SOLUTION / SUBCUTANEOUS	RLD, RS	2020-11-25	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N213793-001	IMCIVREE	EQ 10MG/ML BASE (EQ 10MG/ML BASE)	SOLUTION / SUBCUTANEOUS	RLD, RS	2020-11-25	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N213793-001	IMCIVREE	EQ 10MG/ML BASE (EQ 10MG/ML BASE)	SOLUTION / SUBCUTANEOUS	RLD, RS	2020-11-25	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N213793-001	IMCIVREE	EQ 10MG BASE/ML (EQ 10MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2020-11-25	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 103 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N213793-001	9458195	2027-10-13	Drug substance, Drug product	2020-12-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213793-001	8039435	2032-08-21	Drug substance, Drug product	2020-12-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213793-001	11129869	2034-07-04	Drug product	2021-10-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213793-001	9458195	2027-10-13	Drug substance, Drug product	2020-12-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213793-001	8039435	2032-08-21	Drug substance, Drug product	2020-12-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213793-001	11129869	2034-07-04	Drug product	2021-10-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N213793-001	9458195	2027-10-13	Drug substance, Drug product	2020-12-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213793-001	8039435	2032-08-21	Drug substance, Drug product	2020-12-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213793-001	11129869	2034-07-04	Drug product	2021-10-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213793-001	8039435	2027-10-13	Drug substance, Drug product	2020-12-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213793-001	9458195	2027-10-13	Drug substance, Drug product	2020-12-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213793-001	11129869	2034-07-04	Drug product	2021-10-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213793-001	8039435	2027-10-13	Drug substance, Drug product	2020-12-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213793-001	9458195	2027-10-13	Drug substance, Drug product	2020-12-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213793-001	11129869	2034-07-04	Drug product	2021-10-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213793-001	8039435	2027-10-13	Drug substance, Drug product	2020-12-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213793-001	9458195	2027-10-13	Drug substance, Drug product	2020-12-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213793-001	11129869	2034-07-04	Drug product	2021-10-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213793-001	8039435	2027-10-13	Drug substance, Drug product	2020-12-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213793-001	9458195	2027-10-13	Drug substance, Drug product	2020-12-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213793-001	11129869	2034-07-04	Drug product	2021-10-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213793-001	8039435	2027-10-13	Drug substance, Drug product	2020-12-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213793-001	9458195	2027-10-13	Drug substance, Drug product	2020-12-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213793-001	11129869	2034-07-04	Drug product	2021-10-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213793-001	8039435	2027-10-13	Drug substance, Drug product	2020-12-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213793-001	9458195	2027-10-13	Drug substance, Drug product	2020-12-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213793-001	11129869	2034-07-04	Drug product	2021-10-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N213793-001	8039435	2027-10-13	Drug substance, Drug product	2020-12-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N213793-001	9458195	2027-10-13	Drug substance, Drug product	2020-12-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N213793-001	11129869	2034-07-04	Drug product	2021-10-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N213793-001	8039435	2027-10-13	Drug substance, Drug product	2020-12-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N213793-001	9458195	2027-10-13	Drug substance, Drug product	2020-12-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N213793-001	11129869	2034-07-04	Drug product	2021-10-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N213793-001	8039435	2027-10-13	Drug substance, Drug product	2020-12-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N213793-001	9458195	2027-10-13	Drug substance, Drug product	2020-12-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N213793-001	11129869	2034-07-04	Drug product	2021-10-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N213793-001	8039435	2027-10-13	Drug substance, Drug product	2020-12-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N213793-001	9458195	2027-10-13	Drug substance, Drug product	2020-12-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N213793-001	11129869	2034-07-04	Drug product	2021-10-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N213793-001	8039435	2027-10-13	Drug substance, Drug product	2020-12-22	`8072bd15b7f6…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 4 · 130 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N213793-001	ODE-336	2027-11-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213793-001	NPP	2027-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213793-001	ODE-402	2029-06-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213793-001	ODE-508	2031-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213793-001	ODE-509	2031-12-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213793-001	I-892	2025-06-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213793-001	NCE	2025-11-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213793-001	ODE-336	2027-11-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213793-001	NPP	2027-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213793-001	ODE-402	2029-06-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213793-001	ODE-508	2031-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213793-001	ODE-509	2031-12-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N213793-001	I-892	2025-06-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213793-001	NCE	2025-11-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213793-001	ODE-336	2027-11-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213793-001	NPP	2027-12-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213793-001	ODE-402	2029-06-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213793-001	ODE-508	2031-12-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213793-001	ODE-509	2031-12-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213793-001	I-892	2025-06-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213793-001	NCE	2025-11-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213793-001	ODE-336	2027-11-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213793-001	NPP	2027-12-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213793-001	ODE-402	2029-06-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213793-001	I-892	2025-06-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213793-001	NCE	2025-11-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213793-001	ODE-336	2027-11-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213793-001	NPP	2027-12-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213793-001	ODE-402	2029-06-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213793-001	I-892	2025-06-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213793-001	NCE	2025-11-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213793-001	ODE-336	2027-11-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213793-001	ODE-402	2029-06-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213793-001	I-892	2025-06-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213793-001	NCE	2025-11-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213793-001	ODE-336	2027-11-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213793-001	ODE-402	2029-06-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213793-001	I-892	2025-06-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213793-001	NCE	2025-11-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213793-001	ODE-336	2027-11-25	`5bbf6a4d5a75…`

Additional Listing Data#

Finished product: Yes
Brand name base: Imcivree
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SETMELANOTIDE	10 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
N7T15V1FUY	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2469346	Internal RxNorm lookup
2469351	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
70c3ccf7-4df0-4c75-ba07-fede9970c8d9	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
765155f1-c557-4cd1-822f-7d6b45942b2e	Product name	1	20210601

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2025-05-16	These highlights do not include all the information needed to use IMCIVREE safely and effectively. See full prescribing information for IMCIVREE. IMCIVREE® (setmelanotide) injection, for subcutaneous use Initial U.S. Approval: 2020
2025-05-16	These highlights do not include all the information needed to use IMCIVREE safely and effectively. See full prescribing information for IMCIVREE. IMCIVREE® (setmelanotide) injection, for subcutaneous use Initial U.S. Approval: 2020
2025-01-30	These highlights do not include all the information needed to use IMCIVREE safely and effectively. See full prescribing information for IMCIVREE. IMCIVREE® (setmelanotide) injection, for subcutaneous use Initial U.S. Approval: 2020
2025-01-30	These highlights do not include all the information needed to use IMCIVREE safely and effectively. See full prescribing information for IMCIVREE. IMCIVREE® (setmelanotide) injection, for subcutaneous use Initial U.S. Approval: 2020
2022-04-11	These highlights do not include all the information needed to use IMCIVREE safely and effectively. See full prescribing information for IMCIVREE. IMCIVREE® (setmelanotide) injection, for subcutaneous use Initial U.S. Approval: 2020
2022-04-11	These highlights do not include all the information needed to use IMCIVREE safely and effectively. See full prescribing information for IMCIVREE. IMCIVREE® (setmelanotide) injection, for subcutaneous use Initial U.S. Approval: 2020
2022-01-28	These highlights do not include all the information needed to use IMCIVREE safely and effectively. See full prescribing information for IMCIVREE. IMCIVREE® (setmelanotide) injection, for subcutaneous use Initial U.S. Approval: 2020
2022-01-28	These highlights do not include all the information needed to use IMCIVREE safely and effectively. See full prescribing information for IMCIVREE. IMCIVREE® (setmelanotide) injection, for subcutaneous use Initial U.S. Approval: 2020

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
72829-010-01	Imcivree	1 mL in 1 VIAL, MULTI-DOSE	SOLUTION	1		14
72829-010-01	Imcivree	1 in 1 CARTON	SOLUTION	1		14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72829-010-01	ML - Milliliter	72829-010	8497a100-ae5f-48ef-a2bb-4a154cde3752	1	2021-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72829-010	IMCIVREE (SETMELANOTIDE) SOLUTION [RHYTHM PHARMACEUTICALS, INC]	9	Current NDC, Legacy NDC, 2 package rows	20250523_70c3ccf7-4df0-4c75-ba07-fede9970c8d9.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
Imcivree	SETMELANOTIDE	Rhythm Pharmaceuticals, Inc	70c3ccf7-4df0-4c75-ba07-fede9970c8d9	2026-04-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 213793 application number: NDA213793 ndc (package): 72829-010-01 ndc (product): 72829-010 ndc11 (package): 72829001001

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
N7T15V1FUY	SETMELANOTIDE	920014-72-8	SETMELANOTIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2469351	IMCIVREE 10 MG/ML Injectable Solution	PSN	70c3ccf7-4df0-4c75-ba07-fede9970c8d9	14
2469346	setmelanotide 10 MG/ML Injectable Solution	PSN	70c3ccf7-4df0-4c75-ba07-fede9970c8d9	14
2469351	setmelanotide 10 MG/ML Injectable Solution [Imcivree]	SBD	70c3ccf7-4df0-4c75-ba07-fede9970c8d9	14
2469346	setmelanotide 10 MG/ML Injectable Solution	SCD	70c3ccf7-4df0-4c75-ba07-fede9970c8d9	14
2469351	Imcivree 10 MG/ML (as setmelanotide acetate) Injectable Solution	SY	70c3ccf7-4df0-4c75-ba07-fede9970c8d9	14
2469351	Imcivree 10 MG/ML Injectable Solution	SY	70c3ccf7-4df0-4c75-ba07-fede9970c8d9	14
2469346	setmelanotide 10 MG/ML (as setmelanotide acetate) Injectable Solution	SY	70c3ccf7-4df0-4c75-ba07-fede9970c8d9	14

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
72829-010-01	72829001001	1 VIAL, MULTI-DOSE in 1 CARTON (72829-010-01) / 1 mL in 1 VIAL, MULTI-DOSE	2020-12-14	0000-00-00	No	No	Current