Application 218590

Type: NDA
Sponsor: PURDUE PHARMA LP

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ZURNAI (AUTOINJECTOR)	NALMEFENE HYDROCHLORIDE	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	EQ 1.5MG BASE/0.5ML (EQ 1.5MG BASE/0.5ML)	Yes	Yes

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
N218590-001	ZURNAI (AUTOINJECTOR)	NALMEFENE HYDROCHLORIDE	EQ 1.5MG BASE/0.5ML (EQ 1.5MG BASE/0.5ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS		RLD, RS	2024-08-07

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N218590-001	11857547	2039-11-05		Drug product	2024-09-05
N218590-001	11865112	2039-11-05	U-3630	Drug product	2024-09-05

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N218590-001	NP	2027-08-07

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	N218590-001	ZURNAI (AUTOINJECTOR)	EQ 1.5MG BASE/0.5ML (EQ 1.5MG BASE/0.5ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD, RS	2024-08-07	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N218590-001	ZURNAI (AUTOINJECTOR)	EQ 1.5MG BASE/0.5ML (EQ 1.5MG BASE/0.5ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD, RS	2024-08-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N218590-001	ZURNAI (AUTOINJECTOR)	EQ 1.5MG BASE/0.5ML (EQ 1.5MG BASE/0.5ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD, RS	2024-08-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218590-001	ZURNAI (AUTOINJECTOR)	EQ 1.5MG BASE/0.5ML (EQ 1.5MG BASE/0.5ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD, RS	2024-08-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N218590-001	ZURNAI (AUTOINJECTOR)	EQ 1.5MG BASE/0.5ML (EQ 1.5MG BASE/0.5ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD	2024-08-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218590-001	ZURNAI (AUTOINJECTOR)	EQ 1.5MG BASE/0.5ML (EQ 1.5MG BASE/0.5ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD	2024-08-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N218590-001	ZURNAI (AUTOINJECTOR)	EQ 1.5MG BASE/0.5ML (EQ 1.5MG BASE/0.5ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD	2024-08-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N218590-001	ZURNAI (AUTOINJECTOR)	EQ 1.5MG BASE/0.5ML (EQ 1.5MG BASE/0.5ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD, RS	2024-08-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N218590-001	ZURNAI (AUTOINJECTOR)	EQ 1.5MG BASE/0.5ML (EQ 1.5MG BASE/0.5ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD, RS	2024-08-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N218590-001	ZURNAI (AUTOINJECTOR)	EQ 1.5MG BASE/0.5ML (EQ 1.5MG BASE/0.5ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD, RS	2024-08-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N218590-001	ZURNAI (AUTOINJECTOR)	EQ 1.5MG BASE/0.5ML (EQ 1.5MG BASE/0.5ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD, RS	2024-08-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N218590-001	ZURNAI (AUTOINJECTOR)	EQ 1.5MG BASE/0.5ML (EQ 1.5MG BASE/0.5ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD, RS	2024-08-07	`d06236e962d9…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218590-001	ZURNAI (AUTOINJECTOR)	EQ 1.5MG BASE/0.5ML (EQ 1.5MG BASE/0.5ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD, RS	2024-08-07	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 4 · 159 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	N218590-001	11857547	2039-11-05		Drug product	2024-09-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218590-001	11865112	2039-11-05	U-3630	Drug product	2024-09-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N218590-001	11857547	2039-11-05		Drug product	2024-09-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218590-001	11865112	2039-11-05	U-3630	Drug product	2024-09-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N218590-001	11857547	2039-11-05		Drug product	2024-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218590-001	11865112	2039-11-05	U-3630	Drug product	2024-09-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218590-001	11857547	2039-11-05		Drug product	2024-09-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218590-001	11865112	2039-11-05	U-3630	Drug product	2024-09-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N218590-001	11857547	2039-11-05		Drug product	2024-09-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N218590-001	11865112	2039-11-05	U-3630	Drug product	2024-09-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218590-001	10478560	2026-01-24		Drug product	2024-09-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218590-001	11446441	2026-01-24		Drug product	2024-09-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218590-001	8562564	2026-01-24		Drug product	2024-09-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218590-001	9180259	2026-01-24		Drug product	2024-09-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218590-001	9533102	2026-01-24		Drug product	2024-09-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218590-001	9629959	2026-01-24		Drug product	2024-09-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218590-001	8021335	2026-10-04		Drug product	2024-09-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218590-001	10279131	2031-07-31		Drug product	2024-09-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218590-001	10357609	2031-08-21		Drug product	2024-09-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218590-001	10905827	2031-08-21		Drug product	2024-09-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218590-001	11446440	2031-08-21		Drug product	2024-09-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218590-001	8496619	2031-08-21		Drug product	2024-09-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218590-001	9364610	2031-08-21		Drug product	2024-09-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218590-001	9364611	2031-08-21		Drug product	2024-09-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218590-001	9446195	2031-08-21		Drug product	2024-09-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218590-001	11185642	2031-08-28		Drug product	2024-09-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218590-001	10881798	2034-02-11		Drug product	2024-09-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218590-001	11813435	2035-02-25		Drug product	2024-09-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218590-001	11191908	2035-10-18		Drug product	2024-09-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218590-001	11857547	2039-11-05		Drug product	2024-09-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218590-001	11865112	2039-11-05	U-3630	Drug product	2024-09-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N218590-001	10478560	2026-01-24		Drug product	2024-09-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N218590-001	11446441	2026-01-24		Drug product	2024-09-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N218590-001	8562564	2026-01-24		Drug product	2024-09-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N218590-001	9180259	2026-01-24		Drug product	2024-09-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N218590-001	9533102	2026-01-24		Drug product	2024-09-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N218590-001	9629959	2026-01-24		Drug product	2024-09-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N218590-001	8021335	2026-10-04		Drug product	2024-09-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N218590-001	10279131	2031-07-31		Drug product	2024-09-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N218590-001	10357609	2031-08-21		Drug product	2024-09-05	`b8a1b40f171c…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-09-14 22:38:34	2026-08	N218590-001	NP	2027-08-07	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N218590-001	NP	2027-08-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N218590-001	NP	2027-08-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218590-001	NP	2027-08-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N218590-001	NP	2027-08-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218590-001	NP	2027-08-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N218590-001	NP	2027-08-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N218590-001	NP	2027-08-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N218590-001	NP	2027-08-07	`2680178bc6a6…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N218590-001	NP	2027-08-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N218590-001	NP	2027-08-07	`d06236e962d9…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218590-001	NP	2027-08-07	`a50c72e98297…`

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
Zurnai	NALMEFENE HYDROCHLORIDE	Knoa Pharma LLC	a59a5847-9fe4-4341-a203-be0a5e6d3e36	2026-07-31	Warnings, Adverse reactions	Exact identifier application applno (NDA): 218590 application number: NDA218590

Documents#

Document, Submission type, Date table
Document	Submission type	Date
81374	ORIG	2025-02-26
81337	ORIG	2025-02-24
79356	ORIG	2024-10-15