Naloxone Hydrochloride

Product NDC: 67457-987
Requested package NDC: 67457-987-10
11-digit product format: 674570987
Labeler code: 67457
Product ID: 67457-987_4f711224-09e7-4c4e-8780-e7e76c572f8c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: naloxone hydrochloride
Dosage form: INJECTION, SOLUTION
Route: INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler: Mylan Institutional LLC
Application: ANDA205014
Marketing category: ANDA
Marketing start: 2019-11-20
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: 2022-12-31
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	67457-987	67457-987-10	D	Discontinued by firm		2026-08-11

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
A205014-001	NALOXONE HYDROCHLORIDE	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP		2016-06-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A205014-001	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	A205014-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2016-06-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205014-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2016-06-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205014-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2016-06-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205014-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2016-06-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205014-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2016-06-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205014-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2016-06-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205014-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2016-06-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205014-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2016-06-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205014-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2016-06-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205014-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2016-06-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205014-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2016-06-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205014-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2016-06-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205014-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2016-06-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205014-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2016-06-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205014-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2016-06-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205014-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2016-06-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205014-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2016-06-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205014-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2016-06-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205014-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2016-06-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205014-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2016-06-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205014-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2016-06-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205014-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2016-06-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205014-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2016-06-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205014-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2016-06-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A205014-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2016-06-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A205014-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2016-06-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A205014-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2016-06-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205014-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2016-06-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A205014-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2016-06-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A205014-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2016-06-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A205014-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2016-06-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A205014-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2016-06-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A205014-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2016-06-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A205014-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2016-06-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A205014-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2016-06-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A205014-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2016-06-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A205014-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2016-06-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A205014-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2016-06-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A205014-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2016-06-29	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A205014-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2016-06-29	`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	A205014-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205014-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205014-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205014-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205014-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205014-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205014-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205014-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205014-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205014-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205014-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205014-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205014-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205014-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205014-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205014-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205014-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205014-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205014-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205014-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205014-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205014-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205014-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205014-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A205014-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A205014-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A205014-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205014-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A205014-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A205014-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A205014-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A205014-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A205014-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A205014-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A205014-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A205014-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A205014-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A205014-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A205014-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A205014-001	AP	1	`cb3db0bc1861…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
67457-987-00	ML - Milliliter	67457-987	659fafc2-1754-4e23-a909-3c3e6fb5b071	1	2019-12-10
67457-987-10	ML - Milliliter	67457-987	f7edad61-3b40-45b8-84cc-f4c2b7270142	1	2019-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67457-987	NALOXONE HYDROCHLORIDE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC]	3	Legacy NDC	20210721_8eb8cb6a-8e50-4f22-a516-6831552baa0d.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Naloxone Hydrochloride	NALOXONE HYDROCHLORIDE	Mylan Institutional LLC	d96ebf2e-1051-4b5b-b1c6-2543dbbb2d04	2021-04-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205014 application number: ANDA205014

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	Marketing start	Marketing end	Sample	Exclude flag	Status
67457-987-10	67457098710	10 VIAL, MULTI-DOSE in 1 CARTON (67457-987-10) > 10 mL in 1 VIAL, MULTI-DOSE (67457-987-00)	2019-11-20	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Naloxone Hydrochloride - Mylan Institutional LLC	Mylan Institutional LLC	2021-04-14	HUMAN PRESCRIPTION DRUG LABEL	3