Application 072076

Type: ANDA
Sponsor: INTL MEDICATION

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NALOXONE HYDROCHLORIDE	NALOXONE HYDROCHLORIDE	INJECTABLE;INJECTION	1MG/ML	No	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
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…`

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 ndc (product): 0404-9922
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 (product): 70518-2725
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 ndc (product): 76329-3369 ndc (product): 76329-1469
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 ndc (product): 51662-1239
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 ndc (product): 71872-7177
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 ndc (product): 71872-7294
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 ndc (product): 76329-3469

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 46 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0404-9921	NALOXONE HYDROCHLORIDE	naloxone hydrochloride	Henry Schein, Inc.	ANDA	Current
0404-9921	NALOXONE HYDROCHLORIDE	naloxone hydrochloride	Henry Schein, Inc.	ANDA	Current
0404-9922	NALOXONE HYDROCHLORIDE	naloxone hydrochloride	Henry Schein, Inc	ANDA	Current
0404-9922	NALOXONE HYDROCHLORIDE	naloxone hydrochloride	Henry Schein, Inc	ANDA	Current
0404-9922	NALOXONE HYDROCHLORIDE	naloxone hydrochloride	Henry Schein, Inc	ANDA	Current
0404-9922	NALOXONE HYDROCHLORIDE	naloxone hydrochloride	Henry Schein, Inc	ANDA	Current
0404-9922	NALOXONE HYDROCHLORIDE	naloxone hydrochloride	Henry Schein, Inc	ANDA	Current
0404-9922	NALOXONE HYDROCHLORIDE	naloxone hydrochloride	Henry Schein, Inc	ANDA	Current
50090-3154	Naloxone Hydrochloride	Naloxone Hydrochloride	A-S Medication Solutions	ANDA	Current
51662-1239	NALOXONE HYDROCHLORIDE	NALOXONE HYDROCHLORIDE	HF Acquisition Co. LLC, DBA HealthFirst	ANDA	Current
51662-1239	NALOXONE HYDROCHLORIDE	NALOXONE HYDROCHLORIDE	HF Acquisition Co. LLC, DBA HealthFirst	ANDA	Current
51662-1239	NALOXONE HYDROCHLORIDE	NALOXONE HYDROCHLORIDE	HF Acquisition Co. LLC, DBA HealthFirst	ANDA	Current
51662-1239	NALOXONE HYDROCHLORIDE	NALOXONE HYDROCHLORIDE	HF Acquisition Co. LLC, DBA HealthFirst	ANDA	Current
51662-1239	NALOXONE HYDROCHLORIDE	NALOXONE HYDROCHLORIDE	HF Acquisition Co. LLC, DBA HealthFirst	ANDA	Current
52584-369	NALOXONE HYDROCHLORIDE	naloxone hydrochloride	General Injectables & Vaccines, Inc.	ANDA	Current
52584-369	NALOXONE HYDROCHLORIDE	naloxone hydrochloride	General Injectables & Vaccines, Inc.	ANDA	Current
52584-369	NALOXONE HYDROCHLORIDE	naloxone hydrochloride	General Injectables & Vaccines, Inc.	ANDA	Current
52584-369	NALOXONE HYDROCHLORIDE	naloxone hydrochloride	General Injectables & Vaccines, Inc.	ANDA	Current
52584-369	NALOXONE HYDROCHLORIDE	naloxone hydrochloride	General Injectables & Vaccines, Inc.	ANDA	Current
52584-469	Naloxone Hydrochloride	Naloxone Hydrochloride	General Injectables & Vaccines, Inc.	ANDA	Current
52584-978	NALOXONE HYDROCHLORIDE	naloxone hydrochloride	General Injectables & Vaccines, Inc	ANDA	Current
52584-978	NALOXONE HYDROCHLORIDE	naloxone hydrochloride	General Injectables & Vaccines, Inc	ANDA	Current
52584-978	NALOXONE HYDROCHLORIDE	naloxone hydrochloride	General Injectables & Vaccines, Inc	ANDA	Current
52584-978	NALOXONE HYDROCHLORIDE	naloxone hydrochloride	General Injectables & Vaccines, Inc	ANDA	Current
52584-978	NALOXONE HYDROCHLORIDE	naloxone hydrochloride	General Injectables & Vaccines, Inc	ANDA	Current
52584-978	NALOXONE HYDROCHLORIDE	naloxone hydrochloride	General Injectables & Vaccines, Inc	ANDA	Current
55154-3954	Naloxone Hydrochloride	Naloxone Hydrochloride	Cardinal Health	ANDA	Current
55154-3954	Naloxone Hydrochloride	Naloxone Hydrochloride	Cardinal Health	ANDA	Current
70518-2725	Naloxone Hydrochloride	Naloxone Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-2725	Naloxone Hydrochloride	Naloxone Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-2725	Naloxone Hydrochloride	Naloxone Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-2780	Naloxone Hydrochloride	Naloxone Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-2780	Naloxone Hydrochloride	Naloxone Hydrochloride	REMEDYREPACK INC.	ANDA	Current
71872-7177	Naloxone Hydrochloride	Naloxone Hydrochloride	Medical Purchasing Solutions, LLC	ANDA	Current
71872-7294	Naloxone Hydrochloride	Naloxone Hydrochloride	Medical Purchasing Solutions, LLC	ANDA	Current
72336-077	LifEMS NALOXONE	naloxone hydrochloride	Lifsa Drugs LLC	ANDA	Current
72336-077	LifEMS NALOXONE	naloxone hydrochloride	Lifsa Drugs LLC	ANDA	Current
72336-077	LifEMS NALOXONE	naloxone hydrochloride	Lifsa Drugs LLC	ANDA	Current
76329-1469	Naloxone Hydrochloride	Naloxone Hydrochloride	International Medication Systems, Limited	ANDA	Current
76329-1469	Naloxone Hydrochloride	Naloxone Hydrochloride	International Medication Systems, Limited	ANDA	Current
76329-1469	Naloxone Hydrochloride	Naloxone Hydrochloride	International Medication Systems, Limited	ANDA	Current
76329-3369	Naloxone Hydrochloride	Naloxone Hydrochloride	International Medication Systems, Limited	ANDA	Current
76329-3369	Naloxone Hydrochloride	Naloxone Hydrochloride	International Medication Systems, Limited	ANDA	Current
76329-3369	Naloxone Hydrochloride	Naloxone Hydrochloride	International Medication Systems, Limited	ANDA	Current
76329-3469	Naloxone Hydrochloride	Naloxone Hydrochloride	International Medication Systems, Limited	ANDA	Current
76329-3469	Naloxone Hydrochloride	Naloxone Hydrochloride	International Medication Systems, Limited	ANDA	Current