NALOXONE HYDROCHLORIDE

Product NDC: 50090-6963
11-digit product format: 500906963
Labeler code: 50090
Product ID: 50090-6963_7a0088db-1e25-49db-9a22-c99cd6adfd8f
Type: HUMAN OTC DRUG
Nonproprietary name: naloxone hydrochloride
Dosage form: SPRAY
Route: NASAL
Labeler: A-S Medication Solutions
Application: ANDA211951
Marketing category: ANDA
Marketing start: 2023-07-30
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
A211951-001	NALOXONE HYDROCHLORIDE	NALOXONE HYDROCHLORIDE	4MG/SPRAY	SPRAY, METERED / NASAL			2022-06-21

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	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A211951-001	NALOXONE HYDROCHLORIDE	4MG/SPRAY	SPRAY, METERED / NASAL		2022-06-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211951-001	NALOXONE HYDROCHLORIDE	4MG/SPRAY	SPRAY, METERED / NASAL		2022-06-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211951-001	NALOXONE HYDROCHLORIDE	4MG/SPRAY	SPRAY, METERED / NASAL		2022-06-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211951-001	NALOXONE HYDROCHLORIDE	4MG/SPRAY	SPRAY, METERED / NASAL		2022-06-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211951-001	NALOXONE HYDROCHLORIDE	4MG/SPRAY	SPRAY, METERED / NASAL		2022-06-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211951-001	NALOXONE HYDROCHLORIDE	4MG/SPRAY	SPRAY, METERED / NASAL		2022-06-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211951-001	NALOXONE HYDROCHLORIDE	4MG/SPRAY	SPRAY, METERED / NASAL		2022-06-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211951-001	NALOXONE HYDROCHLORIDE	4MG/SPRAY	SPRAY, METERED / NASAL		2022-06-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211951-001	NALOXONE HYDROCHLORIDE	4MG/SPRAY	SPRAY, METERED / NASAL		2022-06-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211951-001	NALOXONE HYDROCHLORIDE	4MG/SPRAY	SPRAY, METERED / NASAL		2022-06-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211951-001	NALOXONE HYDROCHLORIDE	4MG/SPRAY	SPRAY, METERED / NASAL		2022-06-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211951-001	NALOXONE HYDROCHLORIDE	4MG/SPRAY	SPRAY, METERED / NASAL		2022-06-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211951-001	NALOXONE HYDROCHLORIDE	4MG/SPRAY	SPRAY, METERED / NASAL		2022-06-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211951-001	NALOXONE HYDROCHLORIDE	4MG/SPRAY	SPRAY, METERED / NASAL		2022-06-21	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211951-001	NALOXONE HYDROCHLORIDE	4MG/SPRAY	SPRAY, METERED / NASAL		2022-06-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211951-001	NALOXONE HYDROCHLORIDE	4MG/SPRAY	SPRAY, METERED / NASAL		2022-06-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211951-001	NALOXONE HYDROCHLORIDE	4MG/SPRAY	SPRAY, METERED / NASAL		2022-06-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211951-001	NALOXONE HYDROCHLORIDE	4MG/SPRAY	SPRAY, METERED / NASAL		2022-06-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211951-001	NALOXONE HYDROCHLORIDE	4MG/SPRAY	SPRAY, METERED / NASAL		2022-06-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211951-001	NALOXONE HYDROCHLORIDE	4MG/SPRAY	SPRAY, METERED / NASAL	AB	2022-06-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211951-001	NALOXONE HYDROCHLORIDE	4MG/SPRAY	SPRAY, METERED / NASAL	AB	2022-06-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211951-001	NALOXONE HYDROCHLORIDE	4MG/SPRAY	SPRAY, METERED / NASAL	AB	2022-06-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211951-001	NALOXONE HYDROCHLORIDE	4MG/SPRAY	SPRAY, METERED / NASAL	AB	2022-06-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211951-001	NALOXONE HYDROCHLORIDE	4MG/SPRAY	SPRAY, METERED / NASAL	AB	2022-06-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211951-001	NALOXONE HYDROCHLORIDE	4MG/SPRAY	SPRAY, METERED / NASAL	AB	2022-06-21	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211951-001	NALOXONE HYDROCHLORIDE	4MG/SPRAY	SPRAY, METERED / NASAL	AB	2022-06-21	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211951-001	NALOXONE HYDROCHLORIDE	4MG/SPRAY	SPRAY, METERED / NASAL	AB	2022-06-21	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211951-001	NALOXONE HYDROCHLORIDE	4MG/SPRAY	SPRAY, METERED / NASAL		2022-06-21	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211951-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211951-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211951-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211951-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211951-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211951-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211951-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211951-001	AB	1	`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
46f27d04-d4d2-4ef1-9cc5-4d58f4056f06	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	Strength	SPL version
50090-6963-0	NALOXONE HYDROCHLORIDE	.1 mL in 1 VIAL, SINGLE-DOSE	SPRAY	.1		2
50090-6963-0	NALOXONE HYDROCHLORIDE	2 in 1 CARTON	SPRAY	2		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-6963-0	EA - Each	50090-6963	1e771616-a1c3-4104-a6e1-c2066a8ba4b2	1	2024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-6963	NALOXONE HYDROCHLORIDE SPRAY [A-S MEDICATION SOLUTIONS]	2	Current NDC, 2 package rows	20240109_46f27d04-d4d2-4ef1-9cc5-4d58f4056f06.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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
NALOXONE HYDROCHLORIDE	NALOXONE HYDROCHLORIDE	BluePoint Laboratories	327004b0-560a-84d0-e063-6294a90aa743	2026-04-02	Warnings	Exact identifier application applno (ANDA): 211951 application number: ANDA211951
NALOXONE HYDROCHLORIDE	NALOXONE HYDROCHLORIDE	Padagis Israel Pharmaceuticals Ltd	b5d40220-f194-4835-b70c-f304ecb222d5	2026-01-06	Warnings	Exact identifier application applno (ANDA): 211951 application number: ANDA211951
NALOXONE HYDROCHLORIDE	NALOXONE HYDROCHLORIDE	Strategic Sourcing Services LLC	577fbd57-7054-4536-86c1-d43bc99cc7b1	2025-11-19	Warnings	Exact identifier application applno (ANDA): 211951 application number: ANDA211951
NALOXONE HYDROCHLORIDE	NALOXONE HYDROCHLORIDE	AMERISOURCE BERGEN	cce38c13-0d2f-49bb-94fa-6f2bbb4d5984	2025-08-31	Warnings	Exact identifier application applno (ANDA): 211951 application number: ANDA211951
NALOXONE HYDROCHLORIDE	NALOXONE HYDROCHLORIDE	Bryant Ranch Prepack	ed549649-dcbd-41f7-a774-876906751c5a	2024-10-03	Warnings	Exact identifier application applno (ANDA): 211951 application number: ANDA211951
NALOXONE HYDROCHLORIDE	NALOXONE HYDROCHLORIDE	Advanced Rx of Tennessee, LLC	1be2e38b-55ca-abea-e063-6394a90ac548	2024-06-27	Warnings	Exact identifier application applno (ANDA): 211951 application number: ANDA211951
NALOXONE HYDROCHLORIDE	NALOXONE HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	19b0603b-241f-f439-e063-6294a90ae85f	2024-05-30	Warnings	Exact identifier application applno (ANDA): 211951 application number: ANDA211951
NALOXONE HCl	NALOXONE HCL	HF Acquisition Co LLC, DBA HealthFirst	f8fcda15-8ba6-e66a-e053-6294a90a385c	2024-01-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211951 application number: ANDA211951
NALOXONE HYDROCHLORIDE	NALOXONE HYDROCHLORIDE	A-S Medication Solutions	46f27d04-d4d2-4ef1-9cc5-4d58f4056f06	2023-12-27	Warnings	Exact identifier application applno (ANDA): 211951 application number: ANDA211951 ndc (product): 50090-6963
NALOXONE HYDROCHLORIDE	NALOXONE HYDROCHLORIDE	A-S Medication Solutions	0b3b5214-6f91-4bba-82d6-d57b16845df5	2023-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211951 application number: ANDA211951
NALOXONE HYDROCHLORIDE	NALOXONE HYDROCHLORIDE	Proficient Rx LP	8d529b4c-85fd-4e50-9443-9080825307bf	2022-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211951 application number: ANDA211951

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	46f27d04-d4d2-4ef1-9cc5-4d58f4056f06	2
1725059	naloxone hydrochloride 40 MG/ML Nasal Spray	SCD	46f27d04-d4d2-4ef1-9cc5-4d58f4056f06	2
1725059	naloxone HCl 4 MG per 0.1 ML Nasal Spray	SY	46f27d04-d4d2-4ef1-9cc5-4d58f4056f06	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
50090-6963-0	50090696300	2 VIAL, SINGLE-DOSE in 1 CARTON (50090-6963-0) / .1 mL in 1 VIAL, SINGLE-DOSE	2023-12-20	No	No	Current