Naloxone Hydrochloride

Product NDC: 0591-3871
11-digit product format: 005913871
Labeler code: 0591
Product ID: 0591-3871_2c4bb622-fc96-4877-92c8-a15be1636137
Type: HUMAN OTC DRUG
Nonproprietary name: Naloxone Hydrochloride
Dosage form: SPRAY, METERED
Route: NASAL
Labeler: Actavis Pharma, Inc.
Application: ANDA209522
Marketing category: ANDA
Marketing start: 2025-01-17
Substance: NALOXONE HYDROCHLORIDE
Active strength: 4 mg/.1mL
Pharmacologic classes: Opioid Antagonist [EPC], Opioid Antagonists [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
A209522-001	NALOXONE HYDROCHLORIDE	NALOXONE HYDROCHLORIDE	4MG/SPRAY	SPRAY, METERED / NASAL			2019-04-19

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	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A209522-001	NALOXONE HYDROCHLORIDE	4MG/SPRAY	SPRAY, METERED / NASAL		2019-04-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209522-001	NALOXONE HYDROCHLORIDE	4MG/SPRAY	SPRAY, METERED / NASAL		2019-04-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209522-001	NALOXONE HYDROCHLORIDE	4MG/SPRAY	SPRAY, METERED / NASAL		2019-04-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209522-001	NALOXONE HYDROCHLORIDE	4MG/SPRAY	SPRAY, METERED / NASAL		2019-04-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209522-001	NALOXONE HYDROCHLORIDE	4MG/SPRAY	SPRAY, METERED / NASAL		2019-04-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209522-001	NALOXONE HYDROCHLORIDE	4MG/SPRAY	SPRAY, METERED / NASAL		2019-04-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209522-001	NALOXONE HYDROCHLORIDE	4MG/SPRAY	SPRAY, METERED / NASAL		2019-04-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209522-001	NALOXONE HYDROCHLORIDE	4MG/SPRAY	SPRAY, METERED / NASAL		2019-04-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209522-001	NALOXONE HYDROCHLORIDE	4MG/SPRAY	SPRAY, METERED / NASAL		2019-04-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209522-001	NALOXONE HYDROCHLORIDE	4MG/SPRAY	SPRAY, METERED / NASAL		2019-04-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209522-001	NALOXONE HYDROCHLORIDE	4MG/SPRAY	SPRAY, METERED / NASAL		2019-04-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209522-001	NALOXONE HYDROCHLORIDE	4MG/SPRAY	SPRAY, METERED / NASAL		2019-04-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209522-001	NALOXONE HYDROCHLORIDE	4MG/SPRAY	SPRAY, METERED / NASAL		2019-04-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209522-001	NALOXONE HYDROCHLORIDE	4MG/SPRAY	SPRAY, METERED / NASAL		2019-04-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209522-001	NALOXONE HYDROCHLORIDE	4MG/SPRAY	SPRAY, METERED / NASAL	AB	2019-04-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209522-001	NALOXONE HYDROCHLORIDE	4MG/SPRAY	SPRAY, METERED / NASAL	AB	2019-04-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209522-001	NALOXONE HYDROCHLORIDE	4MG/SPRAY	SPRAY, METERED / NASAL	AB	2019-04-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209522-001	NALOXONE HYDROCHLORIDE	4MG/SPRAY	SPRAY, METERED / NASAL		2019-04-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209522-001	NALOXONE HYDROCHLORIDE	4MG/SPRAY	SPRAY, METERED / NASAL	AB	2019-04-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209522-001	NALOXONE HYDROCHLORIDE	4MG/SPRAY	SPRAY, METERED / NASAL		2019-04-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209522-001	NALOXONE HYDROCHLORIDE	4MG/SPRAY	SPRAY, METERED / NASAL		2019-04-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209522-001	NALOXONE HYDROCHLORIDE	4MG/SPRAY	SPRAY, METERED / NASAL		2019-04-19	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209522-001	NALOXONE HYDROCHLORIDE	4MG/SPRAY	SPRAY, METERED / NASAL		2019-04-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209522-001	NALOXONE HYDROCHLORIDE	4MG/SPRAY	SPRAY, METERED / NASAL		2019-04-19	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209522-001	NALOXONE HYDROCHLORIDE	4MG/SPRAY	SPRAY, METERED / NASAL		2019-04-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209522-001	NALOXONE HYDROCHLORIDE	4MG/SPRAY	SPRAY, METERED / NASAL		2019-04-19	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209522-001	NALOXONE HYDROCHLORIDE	4MG/SPRAY	SPRAY, METERED / NASAL		2019-04-19	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209522-001	NALOXONE HYDROCHLORIDE	4MG/SPRAY	SPRAY, METERED / NASAL		2019-04-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209522-001	NALOXONE HYDROCHLORIDE	4MG/SPRAY	SPRAY, METERED / NASAL		2019-04-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209522-001	NALOXONE HYDROCHLORIDE	4MG/SPRAY	SPRAY, METERED / NASAL		2019-04-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209522-001	NALOXONE HYDROCHLORIDE	4MG/SPRAY	SPRAY, METERED / NASAL		2019-04-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209522-001	NALOXONE HYDROCHLORIDE	4MG/SPRAY	SPRAY, METERED / NASAL		2019-04-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209522-001	NALOXONE HYDROCHLORIDE	4MG/SPRAY	SPRAY, METERED / NASAL	AB	2019-04-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209522-001	NALOXONE HYDROCHLORIDE	4MG/SPRAY	SPRAY, METERED / NASAL	AB	2019-04-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209522-001	NALOXONE HYDROCHLORIDE	4MG/SPRAY	SPRAY, METERED / NASAL	AB	2019-04-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209522-001	NALOXONE HYDROCHLORIDE	4MG/SPRAY	SPRAY, METERED / NASAL	AB	2019-04-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209522-001	NALOXONE HYDROCHLORIDE	4MG/SPRAY	SPRAY, METERED / NASAL	AB	2019-04-19	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209522-001	NALOXONE HYDROCHLORIDE	4MG/SPRAY	SPRAY, METERED / NASAL	AB	2019-04-19	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209522-001	NALOXONE HYDROCHLORIDE	4MG/SPRAY	SPRAY, METERED / NASAL	AB	2019-04-19	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209522-001	NALOXONE HYDROCHLORIDE	4MG/SPRAY	SPRAY, METERED / NASAL	AB	2019-04-19	`cb3db0bc1861…`

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	A209522-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209522-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209522-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A209522-001	AB	1	`bb7c543d1eb4…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209522-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209522-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209522-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209522-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209522-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209522-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209522-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209522-001	AB	1	`cb3db0bc1861…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209522-001	PC	2022-06-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209522-001	PC	2022-06-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209522-001	PC	2022-06-20	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A209522-001	PC	2022-06-20	`bb7c543d1eb4…`
2023-01-26 05:58 UTC	2023-01	A209522-001	PC	2022-06-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209522-001	PC	2022-06-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209522-001	PC	2022-06-20	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209522-001	PC	2022-06-20	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209522-001	PC	2022-06-20	`cb3db0bc1861…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NALOXONE HYDROCHLORIDE	4 mg/.1mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
F850569PQR	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1725059	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
49350f7e-d613-40a8-8941-a2ec30eafdf3	Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0591-3871-54	Naloxone Hydrochloride	1 in 1 BLISTER PACK	SPRAY, METERED	1	1
0591-3871-54	Naloxone Hydrochloride	0.1 mL in 1 VIAL, SINGLE-DOSE	SPRAY, METERED	0.1	1
0591-3871-99	Naloxone Hydrochloride	2 in 1 CARTON	SPRAY, METERED	2	1

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Naloxone Hydrochloride	NALOXONE HYDROCHLORIDE	Sportpharm LLC	3750bf77-342c-4469-8bbb-f71009aa03fa	2026-07-02	Warnings	Exact identifier application applno (ANDA): 209522 application number: ANDA209522
Naloxone Hydrochloride	NALOXONE HYDROCHLORIDE	Asclemed USA, Inc.	7acf3bde-f858-4fbc-8a11-6741a3d27b8e	2024-10-29	Warnings	Exact identifier application applno (ANDA): 209522 application number: ANDA209522
Naloxone Hydrochloride	NALOXONE HYDROCHLORIDE	Actavis Pharma, Inc.	49350f7e-d613-40a8-8941-a2ec30eafdf3	2024-01-30	Warnings	Exact identifier application applno (ANDA): 209522 application number: ANDA209522 ndc (product): 0591-3871
Naloxone Hydrochloride	NALOXONE HYDROCHLORIDE	Teva Pharmaceuticals, Inc.	3a73ee4b-c2a4-496f-be90-9f78c8046062	2024-01-01	Warnings	Exact identifier application applno (ANDA): 209522 application number: ANDA209522

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	49350f7e-d613-40a8-8941-a2ec30eafdf3	1
1725059	naloxone hydrochloride 40 MG/ML Nasal Spray	SCD	49350f7e-d613-40a8-8941-a2ec30eafdf3	1
1725059	naloxone HCl 4 MG per 0.1 ML Nasal Spray	SY	49350f7e-d613-40a8-8941-a2ec30eafdf3	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
0591-3871-54	00591387154	1 in 1 BLISTER PACK					Historical
0591-3871-99	00591387199	2 BLISTER PACK in 1 CARTON (0591-3871-99) / 1 VIAL, SINGLE-DOSE in 1 BLISTER PACK (0591-3871-54) / .1 mL in 1 VIAL, SINGLE-DOSE	2 blister pack	2025-01-17	No	No	Current