NALOXONE HYDROCHLORIDE

Product NDC: 52584-978
Requested package NDC: 52584-978-01
11-digit product format: 525840978
Labeler code: 52584
Product ID: 52584-978_37100309-f0a5-4948-a019-88c2b1ef9f6f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: naloxone hydrochloride
Dosage form: INJECTION
Route: PARENTERAL
Labeler: General Injectables & Vaccines, Inc
Application: ANDA072076
Marketing category: ANDA
Marketing start: 2013-12-06
Marketing end: 2024-02-29
Substance: NALOXONE HYDROCHLORIDE
Active strength: 1 mg/mL
Pharmacologic classes: Opioid Antagonist [EPC], Opioid Antagonists [MoA]
NDC exclude flag: No
Listing certified through: 0000-00-00
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	52584-978	52584-978-01	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 · 12 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…`

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
A072076-001	NALOXONE HYDROCHLORIDE	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	RS	1988-03-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A072076-001	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A072076-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	RS	1988-03-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072076-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	RS	1988-03-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A072076-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	RS	1988-03-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072076-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	RS	1988-03-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072076-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	RS	1988-03-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072076-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	RS	1988-03-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072076-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	RS	1988-03-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072076-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	RS	1988-03-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072076-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	RS	1988-03-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A072076-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	RS	1988-03-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072076-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	RS	1988-03-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072076-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	RS	1988-03-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072076-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	RS	1988-03-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A072076-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	RS	1988-03-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A072076-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	RS	1988-03-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A072076-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	RS	1988-03-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A072076-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	RS	1988-03-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A072076-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION		RS	1988-03-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A072076-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	RS	1988-03-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A072076-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	RS	1988-03-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A072076-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	RS	1988-03-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A072076-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	RS	1988-03-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A072076-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	RS	1988-03-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A072076-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	RS	1988-03-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A072076-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION		RS	1988-03-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A072076-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION		RS	1988-03-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A072076-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION		RS	1988-03-24	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A072076-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	RS	1988-03-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A072076-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	RS	1988-03-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A072076-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	RS	1988-03-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A072076-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	RS	1988-03-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A072076-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	RS	1988-03-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A072076-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	RS	1988-03-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A072076-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	RS	1988-03-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A072076-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	RS	1988-03-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A072076-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	RS	1988-03-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A072076-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	RS	1988-03-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A072076-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	RS	1988-03-24	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A072076-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	RS	1988-03-24	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A072076-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	RS	1988-03-24	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A072076-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072076-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A072076-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072076-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072076-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072076-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072076-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072076-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072076-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A072076-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072076-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072076-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072076-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A072076-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A072076-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A072076-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A072076-001	AP	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A072076-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A072076-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A072076-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A072076-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A072076-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A072076-001	AP	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A072076-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A072076-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A072076-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A072076-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A072076-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A072076-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A072076-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A072076-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A072076-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A072076-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A072076-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A072076-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A072076-001	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A072076-001	AP	1	`a50c72e98297…`

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
NALOXONE HYDROCHLORIDE	ACTIVE INGREDIENT	F850569PQR	NALOXONE HYDROCHLORIDE INJECTION [GENERAL INJECTABLES & VACCINES, INC]	1
NALOXONE	ACTIVE MOIETY	36B82AMQ7N	NALOXONE HYDROCHLORIDE INJECTION [GENERAL INJECTABLES & VACCINES, INC]	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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
NALOXONE HYDROCHLORIDE	NALOXONE HYDROCHLORIDE	Henry Schein, Inc	bd65e3fe-cd7a-4855-8f55-8cc3a0921ccc	2026-03-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072076 application number: ANDA072076
Naloxone Hydrochloride	NALOXONE HYDROCHLORIDE	REMEDYREPACK INC.	68df290c-d776-4cfc-9565-332eb56c4723	2026-02-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072076 application number: ANDA072076
Naloxone Hydrochloride	NALOXONE HYDROCHLORIDE	International Medication Systems, Limited	236349ef-2cb5-47ca-a3a5-99534c3a4996	2024-12-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072076 application number: ANDA072076
NALOXONE HYDROCHLORIDE	NALOXONE HYDROCHLORIDE	HF Acquisition Co. LLC, DBA HealthFirst	74fc593e-ed47-efae-e053-2991aa0a5997	2024-01-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072076 application number: ANDA072076
Naloxone Hydrochloride	NALOXONE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	958577c3-d2c4-26ad-e053-2a95a90ad73a	2023-05-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072076 application number: ANDA072076
Naloxone Hydrochloride	NALOXONE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	ea4ea2fe-af48-0b3c-e053-2a95a90a0ad5	2023-04-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072076 application number: ANDA072076
Naloxone Hydrochloride	NALOXONE HYDROCHLORIDE	International Medication Systems, Limited	d2f5bfa0-933e-46d0-8b1a-9f90e6aaba54	2021-12-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072076 application number: ANDA072076

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	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
52584-978-01	52584097801	1 BOX in 1 BAG (52584-978-01) > 1 SYRINGE in 1 BOX > 2 mL in 1 SYRINGE	1 box	2013-12-06	2024-02-29	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Naloxone Hydrochloride Injection, USP Opioid Antagonist Rx Only	General Injectables & Vaccines, Inc	2022-12-29	HUMAN PRESCRIPTION DRUG LABEL	8