Onivyde

Product NDC: 15054-0043
11-digit product format: 150540043
Labeler code: 15054
Product ID: 15054-0043_72b1786a-3437-4799-8214-f37b5be5607c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: IRINOTECAN HYDROCHLORIDE
Dosage form: INJECTION, POWDER, FOR SOLUTION
Route: INTRAVENOUS
Labeler: Ipsen Biopharmaceuticals, Inc.
Application: NDA207793
Marketing category: NDA
Marketing start: 2015-10-22
Substance: IRINOTECAN HYDROCHLORIDE
Active strength: 4.3 mg/mL
Pharmacologic classes: Topoisomerase Inhibitor [EPC], Topoisomerase Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 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
N207793-001	ONIVYDE	IRINOTECAN HYDROCHLORIDE	EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML)	INJECTABLE, LIPOSOMAL / INTRAVENOUS		RLD, RS	2015-10-22

Orange Book patents#

Current patent rows page 1 of 1 · 17 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N207793-001	8329213	2027-01-06		Drug substance, Drug product	2015-11-18
N207793-001	8147867	2028-08-29		Drug substance, Drug product	2015-11-18
N207793-001	10980795	2033-06-12	U-1848		2021-05-11
N207793-001	11369597	2033-06-12	U-1848		2022-07-20
N207793-001	12364691	2033-06-12	U-1848		2025-08-07
N207793-001	9339497	2033-06-12	U-1848		2016-06-06
N207793-001	9364473	2033-06-12	U-1856		2016-06-24
N207793-001	9452162	2033-06-12	U-1899		2016-09-30
N207793-001	9492442	2033-06-12	U-1848		2016-12-02
N207793-001	9492442	2033-06-12	U-1899		2016-12-02
N207793-001	9492442	2033-06-12	U-1917		2016-12-02
N207793-001	9717724	2033-06-12	U-1848		2017-08-30
N207793-001	9717724	2033-06-12	U-2091		2017-08-30
N207793-001	11344552	2036-08-19	U-3824		2024-03-12
N207793-001	10456360	2036-10-15		Drug product	2019-11-25
N207793-001	10993914	2036-10-15		Drug product	2021-05-11
N207793-001	12059497	2036-10-15		Drug product	2024-09-05

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N207793-001	I-932	2027-02-13
N207793-001	ODE-463	2031-02-13

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N207793-001	ONIVYDE	EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML)	INJECTABLE, LIPOSOMAL / INTRAVENOUS	RLD, RS	2015-10-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207793-001	ONIVYDE	EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML)	INJECTABLE, LIPOSOMAL / INTRAVENOUS	RLD, RS	2015-10-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N207793-001	ONIVYDE	EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML)	INJECTABLE, LIPOSOMAL / INTRAVENOUS	RLD, RS	2015-10-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207793-001	ONIVYDE	EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML)	INJECTABLE, LIPOSOMAL / INTRAVENOUS	RLD, RS	2015-10-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207793-001	ONIVYDE	EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML)	INJECTABLE, LIPOSOMAL / INTRAVENOUS	RLD, RS	2015-10-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207793-001	ONIVYDE	EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML)	INJECTABLE, LIPOSOMAL / INTRAVENOUS	RLD, RS	2015-10-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207793-001	ONIVYDE	EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML)	INJECTABLE, LIPOSOMAL / INTRAVENOUS	RLD, RS	2015-10-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N207793-001	ONIVYDE	EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML)	INJECTABLE, LIPOSOMAL / INTRAVENOUS	RLD, RS	2015-10-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N207793-001	ONIVYDE	EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML)	INJECTABLE, LIPOSOMAL / INTRAVENOUS	RLD, RS	2015-10-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N207793-001	ONIVYDE	EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML)	INJECTABLE, LIPOSOMAL / INTRAVENOUS	RLD, RS	2015-10-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N207793-001	ONIVYDE	EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML)	INJECTABLE, LIPOSOMAL / INTRAVENOUS	RLD, RS	2015-10-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N207793-001	ONIVYDE	EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML)	INJECTABLE, LIPOSOMAL / INTRAVENOUS	RLD, RS	2015-10-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N207793-001	ONIVYDE	EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML)	INJECTABLE, LIPOSOMAL / INTRAVENOUS	RLD, RS	2015-10-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N207793-001	ONIVYDE	EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML)	INJECTABLE, LIPOSOMAL / INTRAVENOUS	RLD, RS	2015-10-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N207793-001	ONIVYDE	EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML)	INJECTABLE, LIPOSOMAL / INTRAVENOUS	RLD, RS	2015-10-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N207793-001	ONIVYDE	EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML)	INJECTABLE, LIPOSOMAL / INTRAVENOUS	RLD, RS	2015-10-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N207793-001	ONIVYDE	EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML)	INJECTABLE, LIPOSOMAL / INTRAVENOUS	RLD, RS	2015-10-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N207793-001	ONIVYDE	EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML)	INJECTABLE, LIPOSOMAL / INTRAVENOUS	RLD, RS	2015-10-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N207793-001	ONIVYDE	EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML)	INJECTABLE, LIPOSOMAL / INTRAVENOUS	RLD, RS	2015-10-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N207793-001	ONIVYDE	EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML)	INJECTABLE, LIPOSOMAL / INTRAVENOUS	RLD, RS	2015-10-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N207793-001	ONIVYDE	EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML)	INJECTABLE, LIPOSOMAL / INTRAVENOUS	RLD, RS	2015-10-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N207793-001	ONIVYDE	EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML)	INJECTABLE, LIPOSOMAL / INTRAVENOUS	RLD, RS	2015-10-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N207793-001	ONIVYDE	EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML)	INJECTABLE, LIPOSOMAL / INTRAVENOUS	RLD, RS	2015-10-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N207793-001	ONIVYDE	EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML)	INJECTABLE, LIPOSOMAL / INTRAVENOUS	RLD, RS	2015-10-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N207793-001	ONIVYDE	EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML)	INJECTABLE, LIPOSOMAL / INTRAVENOUS	RLD, RS	2015-10-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N207793-001	ONIVYDE	EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML)	INJECTABLE, LIPOSOMAL / INTRAVENOUS	RLD, RS	2015-10-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N207793-001	ONIVYDE	EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML)	INJECTABLE, LIPOSOMAL / INTRAVENOUS	RLD, RS	2015-10-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N207793-001	ONIVYDE	EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML)	INJECTABLE, LIPOSOMAL / INTRAVENOUS	RLD, RS	2015-10-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N207793-001	ONIVYDE	EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML)	INJECTABLE, LIPOSOMAL / INTRAVENOUS	RLD, RS	2015-10-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N207793-001	ONIVYDE	EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML)	INJECTABLE, LIPOSOMAL / INTRAVENOUS	RLD, RS	2015-10-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N207793-001	ONIVYDE	EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML)	INJECTABLE, LIPOSOMAL / INTRAVENOUS	RLD, RS	2015-10-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N207793-001	ONIVYDE	EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML)	INJECTABLE, LIPOSOMAL / INTRAVENOUS	RLD, RS	2015-10-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N207793-001	ONIVYDE	EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML)	INJECTABLE, LIPOSOMAL / INTRAVENOUS	RLD, RS	2015-10-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N207793-001	ONIVYDE	EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML)	INJECTABLE, LIPOSOMAL / INTRAVENOUS	RLD, RS	2015-10-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N207793-001	ONIVYDE	EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML)	INJECTABLE, LIPOSOMAL / INTRAVENOUS	RLD, RS	2015-10-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N207793-001	ONIVYDE	EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML)	INJECTABLE, LIPOSOMAL / INTRAVENOUS	RLD, RS	2015-10-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N207793-001	ONIVYDE	EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML)	INJECTABLE, LIPOSOMAL / INTRAVENOUS	RLD, RS	2015-10-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N207793-001	ONIVYDE	EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML)	INJECTABLE, LIPOSOMAL / INTRAVENOUS	RLD, RS	2015-10-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N207793-001	ONIVYDE	EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML)	INJECTABLE, LIPOSOMAL / INTRAVENOUS	RLD, RS	2015-10-22	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N207793-001	ONIVYDE	EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML)	INJECTABLE, LIPOSOMAL / INTRAVENOUS	RLD, RS	2015-10-22	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 20 · 800 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N207793-001	8329213	2027-01-06		Drug substance, Drug product	2015-11-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207793-001	8147867	2028-08-29		Drug substance, Drug product	2015-11-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207793-001	10980795	2033-06-12	U-1848		2021-05-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207793-001	11369597	2033-06-12	U-1848		2022-07-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207793-001	12364691	2033-06-12	U-1848		2025-08-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207793-001	9339497	2033-06-12	U-1848		2016-06-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207793-001	9364473	2033-06-12	U-1856		2016-06-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207793-001	9452162	2033-06-12	U-1899		2016-09-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207793-001	9492442	2033-06-12	U-1917		2016-12-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207793-001	9492442	2033-06-12	U-1899		2016-12-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207793-001	9492442	2033-06-12	U-1848		2016-12-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207793-001	9717724	2033-06-12	U-2091		2017-08-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207793-001	9717724	2033-06-12	U-1848		2017-08-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207793-001	11344552	2036-08-19	U-3824		2024-03-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207793-001	10456360	2036-10-15		Drug product	2019-11-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207793-001	10993914	2036-10-15		Drug product	2021-05-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207793-001	12059497	2036-10-15		Drug product	2024-09-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207793-001	10722508	2025-05-02		Drug substance, Drug product	2020-08-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207793-001	8703181	2025-05-02	U-1434		2015-11-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207793-001	8992970	2025-05-02		Drug substance, Drug product	2015-11-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207793-001	9724303	2025-05-02		Drug substance, Drug product	2017-08-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207793-001	9730891	2025-05-02	U-1848		2017-08-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207793-001	9782349	2025-05-02		Drug substance, Drug product	2017-10-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207793-001	8329213	2027-01-06		Drug substance, Drug product	2015-11-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207793-001	8147867	2028-08-29		Drug substance, Drug product	2015-11-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207793-001	10980795	2033-06-12	U-1848		2021-05-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207793-001	11369597	2033-06-12	U-1848		2022-07-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207793-001	12364691	2033-06-12	U-1848		2025-08-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207793-001	9339497	2033-06-12	U-1848		2016-06-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207793-001	9364473	2033-06-12	U-1856		2016-06-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207793-001	9452162	2033-06-12	U-1899		2016-09-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207793-001	9492442	2033-06-12	U-1917		2016-12-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207793-001	9492442	2033-06-12	U-1899		2016-12-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207793-001	9492442	2033-06-12	U-1848		2016-12-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207793-001	9717724	2033-06-12	U-2091		2017-08-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207793-001	9717724	2033-06-12	U-1848		2017-08-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207793-001	11344552	2036-08-19	U-3824		2024-03-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207793-001	10456360	2036-10-15		Drug product	2019-11-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207793-001	10993914	2036-10-15		Drug product	2021-05-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207793-001	12059497	2036-10-15		Drug product	2024-09-05	`31067a03dcf5…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 49 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	N207793-001	I-932	2027-02-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207793-001	ODE-463	2031-02-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207793-001	I-932	2027-02-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207793-001	ODE-463	2031-02-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N207793-001	I-932	2027-02-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207793-001	ODE-463	2031-02-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207793-001	I-932	2027-02-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207793-001	ODE-463	2031-02-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207793-001	I-932	2027-02-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207793-001	ODE-463	2031-02-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207793-001	I-932	2027-02-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207793-001	ODE-463	2031-02-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207793-001	I-932	2027-02-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207793-001	ODE-463	2031-02-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N207793-001	I-932	2027-02-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N207793-001	ODE-463	2031-02-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N207793-001	I-932	2027-02-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N207793-001	ODE-463	2031-02-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N207793-001	I-932	2027-02-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N207793-001	ODE-463	2031-02-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N207793-001	I-932	2027-02-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N207793-001	ODE-463	2031-02-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N207793-001	I-932	2027-02-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N207793-001	ODE-463	2031-02-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N207793-001	I-932	2027-02-13	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N207793-001	ODE-463	2031-02-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N207793-001	I-932	2027-02-13	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N207793-001	ODE-463	2031-02-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N207793-001	ODE-99	2022-10-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N207793-001	ODE-99	2022-10-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N207793-001	ODE-99	2022-10-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N207793-001	ODE-99	2022-10-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N207793-001	ODE-99	2022-10-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N207793-001	ODE-99	2022-10-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N207793-001	ODE-99	2022-10-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N207793-001	ODE-99	2022-10-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N207793-001	ODE-99	2022-10-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N207793-001	ODE-99	2022-10-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N207793-001	ODE-99	2022-10-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N207793-001	ODE-99	2022-10-22	`b00525d2431f…`

Additional Listing Data#

Finished product: Yes
Brand name base: Onivyde
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
IRINOTECAN HYDROCHLORIDE	4.3 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
042LAQ1IIS	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1719772	Internal RxNorm lookup
1719777	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
c8b58efa-1820-48a4-b70d-62918fc4abfc	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
cfce77d6-e90b-6280-14b8-e6a66a38ebbc	Product name	7	20210525
077454e2-2db8-411c-801d-08d70e0bebab	Product name	1	20151116

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
15054-0043-1	Onivyde	1 in 1 CARTON	INJECTION, POWDER, FOR SOLUTION	1		9
15054-0043-1	Onivyde	10 mL in 1 VIAL, SINGLE-DOSE	INJECTION, POWDER, FOR SOLUTION	10		9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
15054-0043-1	ML - Milliliter	15054-0043	6a07d056-e7fa-4bf2-ac03-37a222965b5c	1	2017-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
15054-0043	ONIVYDE (IRINOTECAN HYDROCHLORIDE) INJECTION, POWDER, FOR SOLUTION [IPSEN BIOPHARMACEUTICALS, INC.]	9	Current NDC, Legacy NDC, 2 package rows	20250305_c8b58efa-1820-48a4-b70d-62918fc4abfc.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
Onivyde	IRINOTECAN HYDROCHLORIDE	Ipsen Biopharmaceuticals, Inc.	c8b58efa-1820-48a4-b70d-62918fc4abfc	2025-03-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 207793 application number: NDA207793 ndc (product): 15054-0043

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
042LAQ1IIS	IRINOTECAN HYDROCHLORIDE	136572-09-3	IRINOTECAN HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1719772	irinotecan HCl liposome 43 MG in 10 ML Injection	PSN	c8b58efa-1820-48a4-b70d-62918fc4abfc	9
1719777	Onivyde 43 MG in 10 ML Injection	PSN	c8b58efa-1820-48a4-b70d-62918fc4abfc	9
1719777	10 ML irinotecan hydrochloride liposome 4.3 MG/ML Injection [Onivyde]	SBD	c8b58efa-1820-48a4-b70d-62918fc4abfc	9
1719772	10 ML irinotecan hydrochloride liposome 4.3 MG/ML Injection	SCD	c8b58efa-1820-48a4-b70d-62918fc4abfc	9
1719777	10 ML Onivyde 4.3 MG/ML Injection	SY	c8b58efa-1820-48a4-b70d-62918fc4abfc	9
1719772	irinotecan hydrochloride liposome 43 MG per 10 ML Injection	SY	c8b58efa-1820-48a4-b70d-62918fc4abfc	9
1719777	Onivyde 43 MG per 10 ML Injection	SY	c8b58efa-1820-48a4-b70d-62918fc4abfc	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
15054-0043-1	15054004301	1 VIAL, SINGLE-DOSE in 1 CARTON (15054-0043-1) / 10 mL in 1 VIAL, SINGLE-DOSE	2015-10-22	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Onivyde	Ipsen Biopharmaceuticals, Inc. \| ScinoPharm Taiwan Ltd. \| Hubei Haosun Pharmaceuticals Co. Ltd \| Ipsen Pharma Biotech \| Boston Analytical \| Quality Chemical Laboratories (QCL) \| Avista	2025-03-03	HUMAN PRESCRIPTION DRUG LABEL	9