Naloxone Hydrochloride

Product NDC: 70518-2725
Requested package NDC: 70518-2725-0
11-digit product format: 705182725
Labeler code: 70518
Product ID: 70518-2725_4a7f0729-7531-bba3-e063-6294a90a001b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Naloxone Hydrochloride
Dosage form: INJECTION
Route: PARENTERAL
Labeler: REMEDYREPACK INC.
Application: ANDA072076
Marketing category: ANDA
Marketing start: 2020-05-05
Substance: NALOXONE HYDROCHLORIDE
Active strength: 1 mg/mL
Pharmacologic classes: Opioid Antagonist [EPC], Opioid Antagonists [MoA]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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 · 1 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	70518-2725	70518-2725-0	D	Discontinued by firm		excluded / ndc_excluded.zip	`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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Naloxone Hydrochloride
Listing expiration: 2027-12-31

Active Ingredients#

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

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
1191250	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
68df290c-d776-4cfc-9565-332eb56c4723	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
70518-2725-0	Naloxone Hydrochloride	10 in 1 BOX	INJECTION	10		8
70518-2725-1	Naloxone Hydrochloride	2 mL in 1 SYRINGE	INJECTION	2		8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70518-2725	NALOXONE HYDROCHLORIDE INJECTION [REMEDYREPACK INC.]	6	Current NDC, Legacy NDC, 2 package rows	20250402_68df290c-d776-4cfc-9565-332eb56c4723.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 · 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 ndc (package): 70518-2725-0 ndc (product): 70518-2725 ndc11 (package): 70518272500
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1191250	naloxone HCl 2 MG in 2 ML Prefilled Syringe	PSN	68df290c-d776-4cfc-9565-332eb56c4723	8
1191250	2 ML naloxone hydrochloride 1 MG/ML Prefilled Syringe	SCD	68df290c-d776-4cfc-9565-332eb56c4723	8
1191250	naloxone hydrochloride 2 MG per 2 ML Prefilled Syringe	SY	68df290c-d776-4cfc-9565-332eb56c4723	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70518-2725-0	70518272500	10 SYRINGE in 1 BOX (70518-2725-0) / 2 mL in 1 SYRINGE (70518-2725-1)	10 syringe	2020-05-05	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Naloxone Hydrochloride - REMEDYREPACK INC.	REMEDYREPACK INC.	2026-02-10	HUMAN PRESCRIPTION DRUG LABEL	8