Naloxone Hydrochloride

Product NDC: 17478-041
Requested package NDC: 17478-041-01
11-digit product format: 174780041
Labeler code: 17478
Product ID: 17478-041_c169f27e-a661-4482-8303-0a0d4d811655
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Naloxone Hydrochloride
Dosage form: INJECTION, SOLUTION
Route: INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler: Akorn
Application: ANDA208871
Marketing category: ANDA
Marketing start: 2017-02-28
Marketing end: 0000-00-00
Substance: NALOXONE HYDROCHLORIDE
Active strength: 0 mg/mL
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	17478-041	17478-041-01	I	Inactivated by FDA		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, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

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
A208871-001	NALOXONE HYDROCHLORIDE	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP		2017-02-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A208871-001	AP

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	A208871-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2017-02-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208871-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2017-02-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208871-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2017-02-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208871-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2017-02-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208871-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2017-02-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208871-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2017-02-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208871-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2017-02-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208871-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2017-02-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208871-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2017-02-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208871-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2017-02-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208871-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2017-02-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208871-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2017-02-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208871-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2017-02-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208871-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2017-02-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208871-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2017-02-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208871-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2017-02-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208871-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2017-02-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208871-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2017-02-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208871-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2017-02-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208871-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2017-02-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208871-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2017-02-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208871-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2017-02-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208871-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2017-02-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208871-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2017-02-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208871-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2017-02-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208871-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2017-02-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208871-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2017-02-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208871-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2017-02-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208871-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2017-02-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208871-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2017-02-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208871-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2017-02-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208871-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2017-02-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208871-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2017-02-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208871-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2017-02-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208871-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2017-02-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208871-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2017-02-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208871-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2017-02-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208871-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2017-02-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208871-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2017-02-28	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208871-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2017-02-28	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A208871-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208871-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208871-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208871-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208871-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208871-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208871-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208871-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208871-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208871-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208871-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208871-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208871-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208871-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208871-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208871-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208871-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208871-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208871-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208871-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208871-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208871-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208871-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208871-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208871-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208871-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208871-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208871-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208871-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208871-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208871-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208871-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208871-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208871-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208871-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208871-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208871-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208871-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208871-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208871-001	AP	1	`cb3db0bc1861…`

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
17478-041-01	2024-01-30	C162847	48780-1	1030e365-6971-111a-e063-dadaa90a10e2	Naloxone Hydrochloride Injection, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
17478-041-01	Naloxone Hydrochloride	1 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION	1		12
17478-041-01	Naloxone Hydrochloride	10 in 1 CARTON	INJECTION, SOLUTION	10		12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
17478-041-01	ML - Milliliter	17478-041	81c63064-39d7-401e-8e9b-1053084ff7af	1	2017-09-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
17478-041	NALOXONE HYDROCHLORIDE INJECTION, SOLUTION [AKORN]	12	Legacy NDC, 2 package rows	20220915_747e602c-93f9-4723-a899-4c1c55c35ef8.zip

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
1659929	naloxone HCl 0.4 MG in 1 ML Injection	PSN	747e602c-93f9-4723-a899-4c1c55c35ef8	12
1191222	naloxone HCl 0.4 MG/ML Injectable Solution	PSN	747e602c-93f9-4723-a899-4c1c55c35ef8	12
1659929	1 ML naloxone hydrochloride 0.4 MG/ML Injection	SCD	747e602c-93f9-4723-a899-4c1c55c35ef8	12
1191222	naloxone hydrochloride 0.4 MG/ML Injectable Solution	SCD	747e602c-93f9-4723-a899-4c1c55c35ef8	12
1659929	naloxone HCl 0.4 MG per 1 ML Injection	SY	747e602c-93f9-4723-a899-4c1c55c35ef8	12

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
17478-041-01	17478004101	10 VIAL, SINGLE-DOSE in 1 CARTON (17478-041-01) > 1 mL in 1 VIAL, SINGLE-DOSE	2017-02-28	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Naloxone Hydrochloride Injection, USP	Medical Purchasing Solutions, LLC	2023-06-21	HUMAN PRESCRIPTION DRUG LABEL	3
Naloxone Hydrochloride Injection, USP	A-S Medication Solutions	2023-03-21	HUMAN PRESCRIPTION DRUG LABEL	9
Naloxone Hydrochloride Injection, USP	Akorn	2022-09-13	HUMAN PRESCRIPTION DRUG LABEL	12
NALOXONE HYDROCHLORIDE	General Injectables and Vaccines, Inc.	2019-12-17	HUMAN PRESCRIPTION DRUG LABEL	4