Naloxone Hydrochloride

Product NDC: 0781-7176
Requested package NDC: 0781-7176-12
11-digit product format: 007817176
Labeler code: 0781
Product ID: 0781-7176_1031b5cb-200d-4478-b754-6391ea5067a7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Naloxone Hydrochloride Nasal Spray
Dosage form: INHALANT
Route: NASAL
Labeler: Sandoz Inc.
Application: NDA208411
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2021-12-20
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: 2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0781-7176	0781-7176-12	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 · 15 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
2025-12-14 17:58 UTC · source 2025-12-05	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
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	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	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…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c955d208-c333-9bd7-be34-d7e12986d44e	Product name	6	20250626
e5f98bfa-66d5-4c3a-b22d-9543d3bee304	Product name	1	20250204
caa6391e-3db3-c912-335f-61b5fc00aa12	Product name	9	20240110
65a3bc34-04ff-4cf1-aad9-c7d92a062f6d	Product name	1	20231003
e951cdf3-f269-4d97-a7d5-c1c3d7283a7d	Product name	3	20230313
ab841ac7-728a-4fc9-be0a-35b96cecbf39	Product name	4	20230306
f327b80c-8fa2-404b-838a-df3eec141cf2	Product name	1	20221212
d4aa2fcf-79c3-4b5f-a00e-1a8e26e00119	Product name	1	20220511
b871fccd-1de6-4c7f-b9e5-045304641ee6	Product name	8	20220118
43b1efe2-1425-4b3e-b3a2-57d40f8478b9	Product name	1	20211026
4c23a34c-e8fc-424c-8fa0-ee064ba6eaef	Product name	1	20170706
0b8c7273-1da3-495f-909a-7cf1e96d2361	Product name	1	20161212
3df867ed-9d48-45cf-bded-1394beaea0b1	Product name	3	20161206
8a245632-e24f-4ccc-b671-995d89c96ebc	Product name	1	20141203

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0781-7176-12	2025-11-04	C162847	48780-1	1030e365-3bc0-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use NALOXONE HCl NASAL SPRAY safely and effectively. See full prescribing information for NALOXONE HCl NASAL SPRAY. NALOXONE HYDROCHLORIDE nasal spray Initial U.S. Approval: 1971
0781-7176-12	2024-01-30	C162847	48780-1	1030e365-3bc0-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use NALOXONE HCl NASAL SPRAY safely and effectively. See full prescribing information for NALOXONE HCl NASAL SPRAY. 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
0781-7176-06	EA - Each	0781-7176	d47252ad-0dea-4c26-9358-46b97f7bc117	1	2022-01-06
0781-7176-12	EA - Each	0781-7176	b14d31ff-6c88-480f-a96d-aaf0bd88a1ac	1	2022-02-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0781-7176	NALOXONE HYDROCHLORIDE (NALOXONE HYDROCHLORIDE NASAL SPRAY) INHALANT [SANDOZ INC.]	2	Legacy NDC	20220105_68723486-8f21-4299-b380-7d5e3f9657b6.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 · 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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1725059	naloxone HCl 4 MG in 0.1 ML Nasal Spray	PSN	4517afa1-4b17-4a15-b91b-65b18bd0558f	3
1725059	naloxone hydrochloride 40 MG/ML Nasal Spray	SCD	4517afa1-4b17-4a15-b91b-65b18bd0558f	3
1725059	naloxone HCl 4 MG per 0.1 ML Nasal Spray	SY	4517afa1-4b17-4a15-b91b-65b18bd0558f	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0781-7176-12	00781717612	2 VIAL, SINGLE-DOSE in 1 CARTON (0781-7176-12) > .1 mL in 1 VIAL, SINGLE-DOSE (0781-7176-06)	2021-12-20	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Naloxone Hydrochloride Nasal Spray	Quality Care Products, LLC	2024-12-19	HUMAN PRESCRIPTION DRUG LABEL	2
Naloxone Hydrochloride	A-S Medication Solutions	2023-11-24	HUMAN PRESCRIPTION DRUG LABEL	3
Naloxone Hydrochloride Nasal Spray	Sandoz Inc.	2021-12-20	HUMAN PRESCRIPTION DRUG LABEL	2