ZIMHI

Product NDC: 38739-600
11-digit product format: 387390600
Labeler code: 38739
Product ID: 38739-600_7dccaf6e-19d0-4720-aac3-c2500a760575
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Naloxone Hydrochloride
Dosage form: INJECTION, SOLUTION
Route: INTRAMUSCULAR; SUBCUTANEOUS
Labeler: Adamis Pharmaceuticals
Application: NDA212854
Marketing category: NDA
Marketing start: 2022-01-15
Marketing end: 0000-00-00
Substance: NALOXONE HYDROCHLORIDE
Active strength: 5 mg/.5mL
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	38739-600		D	Discontinued by firm	2026-08-07
excluded package	package	38739-600	38739-600-01	D	Discontinued by firm	2026-08-07
excluded package	package	38739-600	38739-600-02	D	Discontinued by firm	2026-08-07

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 · 36 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	38739-600-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	38739-600-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	38739-600-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	38739-600-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	38739-600-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	38739-600-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	38739-600-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	38739-600-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	38739-600-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	38739-600-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	38739-600-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	38739-600-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	38739-600-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	38739-600-02	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	38739-600-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	38739-600-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	38739-600-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	38739-600-02	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	38739-600-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	38739-600-02	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	38739-600-01	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	38739-600-02	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	38739-600-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	38739-600-02	`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
N212854-001	ZIMHI	NALOXONE HYDROCHLORIDE	5MG/0.5ML (5MG/0.5ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS		RLD, RS	2021-10-15

Orange Book patents#

Current patent rows page 1 of 1 · 4 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N212854-001	11027072	2039-05-24		Drug product	2022-06-06
N212854-001	11571518	2041-06-14	U-3515	Drug product	2023-02-10
N212854-001	11571518	2041-06-14	U-3516	Drug product	2023-02-10
N212854-001	11571518	2041-06-14	U-3517	Drug product	2023-02-10

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N212854-001	ZIMHI	5MG/0.5ML (5MG/0.5ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD, RS	2021-10-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212854-001	ZIMHI	5MG/0.5ML (5MG/0.5ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD, RS	2021-10-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N212854-001	ZIMHI	5MG/0.5ML (5MG/0.5ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD, RS	2021-10-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212854-001	ZIMHI	5MG/0.5ML (5MG/0.5ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD, RS	2021-10-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212854-001	ZIMHI	5MG/0.5ML (5MG/0.5ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD, RS	2021-10-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212854-001	ZIMHI	5MG/0.5ML (5MG/0.5ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD, RS	2021-10-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212854-001	ZIMHI	5MG/0.5ML (5MG/0.5ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD, RS	2021-10-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212854-001	ZIMHI	5MG/0.5ML (5MG/0.5ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD, RS	2021-10-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212854-001	ZIMHI	5MG/0.5ML (5MG/0.5ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD, RS	2021-10-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N212854-001	ZIMHI	5MG/0.5ML (5MG/0.5ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD, RS	2021-10-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212854-001	ZIMHI	5MG/0.5ML (5MG/0.5ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD, RS	2021-10-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N212854-001	ZIMHI	5MG/0.5ML (5MG/0.5ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD, RS	2021-10-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N212854-001	ZIMHI	5MG/0.5ML (5MG/0.5ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD, RS	2021-10-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N212854-001	ZIMHI	5MG/0.5ML (5MG/0.5ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD, RS	2021-10-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N212854-001	ZIMHI	5MG/0.5ML (5MG/0.5ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD, RS	2021-10-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N212854-001	ZIMHI	5MG/0.5ML (5MG/0.5ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD, RS	2021-10-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N212854-001	ZIMHI	5MG/0.5ML (5MG/0.5ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD, RS	2021-10-15	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N212854-001	ZIMHI	5MG/0.5ML (5MG/0.5ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD, RS	2021-10-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N212854-001	ZIMHI	5MG/0.5ML (5MG/0.5ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD, RS	2021-10-15	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N212854-001	ZIMHI	5MG/0.5ML (5MG/0.5ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD, RS	2021-10-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N212854-001	ZIMHI	5MG/0.5ML (5MG/0.5ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD, RS	2021-10-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N212854-001	ZIMHI	5MG/0.5ML (5MG/0.5ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD, RS	2021-10-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N212854-001	ZIMHI	5MG/0.5ML (5MG/0.5ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD, RS	2021-10-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N212854-001	ZIMHI	5MG/0.5ML (5MG/0.5ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD, RS	2021-10-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N212854-001	ZIMHI	5MG/0.5ML (5MG/0.5ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD, RS	2021-10-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N212854-001	ZIMHI	5MG/0.5ML (5MG/0.5ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD, RS	2021-10-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N212854-001	ZIMHI	5MG/0.5ML (5MG/0.5ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD, RS	2021-10-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N212854-001	ZIMHI	5MG/0.5ML (5MG/0.5ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD, RS	2021-10-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N212854-001	ZIMHI	5MG/0.5ML (5MG/0.5ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD, RS	2021-10-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N212854-001	ZIMHI	5MG/0.5ML (5MG/0.5ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD, RS	2021-10-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N212854-001	ZIMHI	5MG/0.5ML (5MG/0.5ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD, RS	2021-10-15	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N212854-001	ZIMHI	5MG/0.5ML (5MG/0.5ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD, RS	2021-10-15	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N212854-001	ZIMHI	5MG/0.5ML (5MG/0.5ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD, RS	2021-10-15	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 98 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N212854-001	11027072	2039-05-24		Drug product	2022-06-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212854-001	11571518	2041-06-14	U-3515	Drug product	2023-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212854-001	11571518	2041-06-14	U-3516	Drug product	2023-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212854-001	11571518	2041-06-14	U-3517	Drug product	2023-02-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212854-001	11027072	2039-05-24		Drug product	2022-06-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212854-001	11571518	2041-06-14	U-3515	Drug product	2023-02-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212854-001	11571518	2041-06-14	U-3516	Drug product	2023-02-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212854-001	11571518	2041-06-14	U-3517	Drug product	2023-02-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N212854-001	11027072	2039-05-24		Drug product	2022-06-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212854-001	11571518	2041-06-14	U-3515	Drug product	2023-02-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212854-001	11571518	2041-06-14	U-3516	Drug product	2023-02-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212854-001	11571518	2041-06-14	U-3517	Drug product	2023-02-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212854-001	11027072	2039-05-24		Drug product	2022-06-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212854-001	11571518	2041-06-14	U-3515	Drug product	2023-02-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212854-001	11571518	2041-06-14	U-3516	Drug product	2023-02-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212854-001	11571518	2041-06-14	U-3517	Drug product	2023-02-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212854-001	11027072	2039-05-24		Drug product	2022-06-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212854-001	11571518	2041-06-14	U-3515	Drug product	2023-02-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212854-001	11571518	2041-06-14	U-3516	Drug product	2023-02-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212854-001	11571518	2041-06-14	U-3517	Drug product	2023-02-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212854-001	11027072	2039-05-24		Drug product	2022-06-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212854-001	11571518	2041-06-14	U-3515	Drug product	2023-02-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212854-001	11571518	2041-06-14	U-3516	Drug product	2023-02-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212854-001	11571518	2041-06-14	U-3517	Drug product	2023-02-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212854-001	11027072	2039-05-24		Drug product	2022-06-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212854-001	11571518	2041-06-14	U-3515	Drug product	2023-02-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212854-001	11571518	2041-06-14	U-3516	Drug product	2023-02-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212854-001	11571518	2041-06-14	U-3517	Drug product	2023-02-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212854-001	11027072	2039-05-24		Drug product	2022-06-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212854-001	11571518	2041-06-14	U-3515	Drug product	2023-02-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212854-001	11571518	2041-06-14	U-3516	Drug product	2023-02-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212854-001	11571518	2041-06-14	U-3517	Drug product	2023-02-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212854-001	11027072	2039-05-24		Drug product	2022-06-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212854-001	11571518	2041-06-14	U-3515	Drug product	2023-02-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212854-001	11571518	2041-06-14	U-3516	Drug product	2023-02-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212854-001	11571518	2041-06-14	U-3517	Drug product	2023-02-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N212854-001	11027072	2039-05-24		Drug product	2022-06-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N212854-001	11571518	2041-06-14	U-3515	Drug product	2023-02-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N212854-001	11571518	2041-06-14	U-3516	Drug product	2023-02-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N212854-001	11571518	2041-06-14	U-3517	Drug product	2023-02-10	`d06236e962d9…`

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
ZIMHI	NALOXONE HYDROCHLORIDE	ZMI Pharma Inc.	523c0909-bff6-4010-988a-53de18b7cb3f	2025-12-04	Warnings, Adverse reactions	Exact identifier application applno (NDA): 212854 application number: NDA212854

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
38739-600-01	38739060001	1 SYRINGE in 1 CONTAINER (38739-600-01) > .5 mL in 1 SYRINGE	1 syringe	2022-01-15	0000-00-00	No	No	Current
38739-600-02	38739060002	2 SYRINGE in 1 CONTAINER (38739-600-02) > .5 mL in 1 SYRINGE	2 syringe	2022-01-15	0000-00-00	No	No	Current