NARCAN

Product NDC: 55700-457
11-digit product format: 557000457
Labeler code: 55700
Product ID: 55700-457_06719fe0-2433-48aa-b92f-8e7a5c867541
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: naloxone hydrochloride
Dosage form: SPRAY
Route: NASAL
Labeler: Lake Erie Medical DBA Quality Care Products LLC
Application: NDA208411
Marketing category: NDA
Marketing start: 2015-11-18
Marketing end: 0000-00-00
Substance: NALOXONE HYDROCHLORIDE
Active strength: 4 mg/.1mL
Pharmacologic classes: Opioid Antagonist [EPC],Opioid Antagonists [MoA]
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

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

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	55700-457		D	Discontinued by firm		2026-08-11
excluded package	package	55700-457	55700-457-01	D	Discontinued by firm		2026-08-11

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 · 30 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	55700-457-01	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	55700-457-01	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	55700-457-01	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	55700-457-01	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	55700-457-01	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	55700-457-01	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	55700-457-01	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	55700-457-01	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	55700-457-01	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	55700-457-01	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	55700-457-01	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	55700-457-01	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	55700-457-01	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	55700-457-01	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	55700-457-01	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N208411-001	NARCAN	NALOXONE HYDROCHLORIDE	4MG/SPRAY	SPRAY, METERED / NASAL		RLD, RS	2015-11-18
N208411-002	NARCAN	NALOXONE HYDROCHLORIDE	2MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL		RLD	2017-01-24

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 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N208411-001	NARCAN	4MG/SPRAY	SPRAY, METERED / NASAL		RLD, RS	2015-11-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208411-002	NARCAN	2MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL		RLD	2017-01-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208411-001	NARCAN	4MG/SPRAY	SPRAY, METERED / NASAL		RLD, RS	2015-11-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208411-002	NARCAN	2MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL		RLD	2017-01-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208411-001	NARCAN	4MG/SPRAY	SPRAY, METERED / NASAL		RLD, RS	2015-11-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208411-002	NARCAN	2MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL		RLD	2017-01-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208411-001	NARCAN	4MG/SPRAY	SPRAY, METERED / NASAL		RLD, RS	2015-11-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208411-002	NARCAN	2MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL		RLD	2017-01-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208411-001	NARCAN	4MG/SPRAY	SPRAY, METERED / NASAL		RLD, RS	2015-11-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208411-002	NARCAN	2MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL		RLD	2017-01-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208411-001	NARCAN	4MG/SPRAY	SPRAY, METERED / NASAL		RLD, RS	2015-11-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208411-002	NARCAN	2MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL		RLD	2017-01-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208411-001	NARCAN	4MG/SPRAY	SPRAY, METERED / NASAL		RLD, RS	2015-11-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208411-002	NARCAN	2MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL		RLD	2017-01-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208411-001	NARCAN	4MG/SPRAY	SPRAY, METERED / NASAL		RLD, RS	2015-11-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208411-002	NARCAN	2MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL		RLD	2017-01-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208411-001	NARCAN	4MG/SPRAY	SPRAY, METERED / NASAL		RLD, RS	2015-11-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208411-002	NARCAN	2MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL		RLD	2017-01-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208411-001	NARCAN	4MG/SPRAY	SPRAY, METERED / NASAL		RLD, RS	2015-11-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N208411-002	NARCAN	2MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL		RLD	2017-01-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208411-001	NARCAN	4MG/SPRAY	SPRAY, METERED / NASAL		RLD, RS	2015-11-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208411-002	NARCAN	2MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL		RLD	2017-01-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208411-001	NARCAN	4MG/SPRAY	SPRAY, METERED / NASAL		RLD, RS	2015-11-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208411-002	NARCAN	2MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL		RLD	2017-01-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208411-001	NARCAN	4MG/SPRAY	SPRAY, METERED / NASAL		RLD, RS	2015-11-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208411-002	NARCAN	2MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL		RLD	2017-01-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208411-001	NARCAN	4MG/SPRAY	SPRAY, METERED / NASAL		RLD, RS	2015-11-18	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N208411-002	NARCAN	2MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL		RLD	2017-01-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208411-001	NARCAN	4MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	2015-11-18	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208411-002	NARCAN	2MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL		RLD	2017-01-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208411-001	NARCAN	4MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	2015-11-18	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N208411-002	NARCAN	2MG/SPRAY	SPRAY, METERED / NASAL		RLD	2017-01-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208411-001	NARCAN	4MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	2015-11-18	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N208411-002	NARCAN	2MG/SPRAY	SPRAY, METERED / NASAL		RLD	2017-01-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N208411-001	NARCAN	4MG/SPRAY	SPRAY, METERED / NASAL		RLD, RS	2015-11-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N208411-002	NARCAN	2MG/SPRAY	SPRAY, METERED / NASAL		RLD	2017-01-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N208411-001	NARCAN	4MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	2015-11-18	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N208411-002	NARCAN	2MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL		RLD	2017-01-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208411-001	NARCAN	4MG/SPRAY	SPRAY, METERED / NASAL		RLD, RS	2015-11-18	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N208411-002	NARCAN	2MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SPRAY, METERED / NASAL		RLD	2017-01-24	`782e0a99824c…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208411-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208411-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208411-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N208411-001	AB	1	`bb7c543d1eb4…`
2023-01-26 05:58 UTC	2023-01	N208411-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N208411-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N208411-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N208411-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N208411-001	AB	1	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 5 · 178 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2025-08-23 18:47 UTC	2025-08	N208411-002	9480644	2035-03-16	U-1903	Drug product, Delist requested	2017-01-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208411-002	9707226	2035-03-16	U-1903	Drug product, Delist requested	2017-07-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208411-002	9480644	2035-03-16	U-1903	Drug product, Delist requested	2017-01-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208411-002	9707226	2035-03-16	U-1903	Drug product, Delist requested	2017-07-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208411-002	9480644	2035-03-16	U-1903	Drug product, Delist requested	2017-01-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208411-002	9707226	2035-03-16	U-1903	Drug product, Delist requested	2017-07-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208411-002	9480644	2035-03-16	U-1903	Drug product, Delist requested	2017-01-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208411-002	9707226	2035-03-16	U-1903	Drug product, Delist requested	2017-07-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208411-002	9480644	2035-03-16	U-1903	Drug product, Delist requested	2017-01-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208411-002	9707226	2035-03-16	U-1903	Drug product, Delist requested	2017-07-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208411-002	9480644	2035-03-16	U-1903	Drug product, Delist requested	2017-01-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208411-002	9707226	2035-03-16	U-1903	Drug product, Delist requested	2017-07-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208411-002	9480644	2035-03-16	U-1903	Drug product, Delist requested	2017-01-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208411-002	9707226	2035-03-16	U-1903	Drug product, Delist requested	2017-07-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208411-002	9480644	2035-03-16	U-1903	Drug product, Delist requested	2017-01-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N208411-002	9707226	2035-03-16	U-1903	Drug product, Delist requested	2017-07-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208411-002	9480644	2035-03-16	U-1903	Drug product, Delist requested	2017-01-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208411-002	9707226	2035-03-16	U-1903	Drug product, Delist requested	2017-07-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208411-002	9480644	2035-03-16	U-1903	Drug product, Delist requested	2017-01-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208411-002	9707226	2035-03-16	U-1903	Drug product, Delist requested	2017-07-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208411-002	9480644	2035-03-16	U-1903	Drug product, Delist requested	2017-01-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208411-002	9707226	2035-03-16	U-1903	Drug product, Delist requested	2017-07-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208411-002	9480644	2035-03-16	U-1903	Drug product, Delist requested	2017-01-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N208411-002	9707226	2035-03-16	U-1903	Drug product, Delist requested	2017-07-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208411-001	10085937	2035-03-16	U-1903		2018-10-03	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208411-001	9211253	2035-03-16		Drug product	2015-12-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208411-001	9468747	2035-03-16	U-1903	Drug product	2016-10-18	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208411-001	9561177	2035-03-16	U-1903	Drug product	2017-02-07	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208411-001	9629965	2035-03-16	U-1903	Drug product	2017-04-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208411-001	9775838	2035-03-16	U-1903		2017-10-05	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208411-002	9480644	2035-03-16	U-1903	Drug product	2017-01-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208411-002	9707226	2035-03-16	U-1903	Drug product	2017-07-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208411-001	10085937	2035-03-16	U-1903		2018-10-03	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N208411-001	9211253	2035-03-16		Drug product	2015-12-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N208411-001	9468747	2035-03-16	U-1903	Drug product	2016-10-18	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N208411-001	9561177	2035-03-16	U-1903	Drug product	2017-02-07	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N208411-001	9629965	2035-03-16	U-1903	Drug product	2017-04-27	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N208411-001	9775838	2035-03-16	U-1903		2017-10-05	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N208411-002	9480644	2035-03-16	U-1903	Drug product	2017-01-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N208411-002	9707226	2035-03-16	U-1903	Drug product	2017-07-18	`5d02ea3f76ae…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
55700-457-01	2025-01-08	C162847	48780-1	1030e365-6e26-111a-e063-dadaa90a10e2	NARCAN (naloxone hydrochloride) Nasal Spray These highlights do not include all the information needed to use NARCAN NASAL SPRAY safely and effectively. See full prescribing information for NARCAN® NASAL SPRAY.NARCAN® (naloxone hydrochloride) nasal spray Initial U.S. Approval: 1971
55700-457-01	2024-01-30	C162847	48780-1	1030e365-6e26-111a-e063-dadaa90a10e2	NARCAN (naloxone hydrochloride) Nasal Spray These highlights do not include all the information needed to use NARCAN NASAL SPRAY safely and effectively. See full prescribing information for NARCAN® NASAL SPRAY.NARCAN® (naloxone hydrochloride) nasal spray Initial U.S. Approval: 1971

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
55700-457-01	EA - Each	55700-457	20371917-0c6c-4747-82f1-cbf04b680bba	1	2017-03-06

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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
NARCAN	NALOXONE HYDROCHLORIDE NASAL	Sportpharm LLC	3d43b2a2-9cc3-4c14-8ae7-fea4c83a7f92	2026-04-24	Warnings	Exact identifier application applno (NDA): 208411 application number: NDA208411
NARCAN	NALOXONE HYDROCHLORIDE NASAL	Emergent Devices Inc.	a0ebc83d-2892-40de-bc0a-775ce90b30db	2026-04-22	Warnings	Exact identifier application applno (NDA): 208411 application number: NDA208411
Narcan	NALOXONE HYDROCHLORIDE	Emergent Devices Inc.	724df050-5332-4d0a-9a5f-17bf08a547e1	2025-12-05	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208411 application number: NDA208411
Narcan Naloxone HCL	NARCAN NALOXONE HCL	HF Acquisition Co LLC, DBA HealthFirst	11d770b8-b768-ba3d-e063-6394a90a61a6	2024-02-20	Warnings	Exact identifier application applno (NDA): 208411 application number: NDA208411
Naloxone Hydrochloride	NALOXONE HYDROCHLORIDE NASAL	A-S Medication Solutions	4517afa1-4b17-4a15-b91b-65b18bd0558f	2023-11-24	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208411 application number: NDA208411
NARCAN NALOXONE HCI	NARCAN NALOXONE HCI	HF Acquisition Co LLC, DBA HealthFirst	784a0e98-c2d6-f845-e053-2991aa0ac4b4	2023-10-10	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208411 application number: NDA208411
NARCAN	NALOXONE HYDROCHLORIDE	A-S Medication Solutions	139c30b9-5600-48f5-8610-0cacd2782398	2023-09-28	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208411 application number: NDA208411
Narcan	NALOXONE HYDROCHLORIDE	Proficient Rx LP	76b5a1ce-e601-457c-ab35-43533bba4394	2022-08-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208411 application number: NDA208411

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
F850569PQR	NALOXONE HYDROCHLORIDE	357-08-4	NALOXONE HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
55700-457-01	55700045701	2 VIAL, SINGLE-DOSE in 1 PACKAGE (55700-457-01) > .1 mL in 1 VIAL, SINGLE-DOSE	2016-11-18	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
NARCAN	Lake Erie Medical DBA Quality Care Products LLC	2021-08-26	HUMAN PRESCRIPTION DRUG LABEL	5