NALOXONE HYDROCHLORIDE

Product NDC: 51662-1690
Requested package NDC: 51662-1690-3
11-digit product format: 516621690
Labeler code: 51662
Product ID: 51662-1690_53ff9b83-0e45-67e4-e063-6294a90aed3c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: NALOXONE HYDROCHLORIDE
Dosage form: INJECTION
Route: INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler: HF Acquisition Co LLC, DBA HealthFirst
Application: ANDA213209
Marketing category: ANDA
Marketing start: 2020-03-18
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A213209-001	NALOXONE HYDROCHLORIDE	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP		2020-03-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213209-001	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A213209-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2020-03-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A213209-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2020-03-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213209-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2020-03-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213209-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2020-03-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213209-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2020-03-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213209-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2020-03-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213209-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2020-03-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213209-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2020-03-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213209-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2020-03-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213209-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2020-03-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213209-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2020-03-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213209-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2020-03-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213209-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2020-03-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213209-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2020-03-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213209-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2020-03-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213209-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2020-03-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213209-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2020-03-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213209-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2020-03-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213209-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2020-03-16	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213209-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2020-03-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213209-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2020-03-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213209-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2020-03-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A213209-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2020-03-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A213209-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2020-03-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A213209-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2020-03-16	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213209-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2020-03-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213209-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2020-03-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213209-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2020-03-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213209-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2020-03-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213209-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2020-03-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213209-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2020-03-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213209-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2020-03-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213209-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2020-03-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213209-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2020-03-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213209-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2020-03-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213209-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2020-03-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213209-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2020-03-16	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213209-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2020-03-16	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213209-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2020-03-16	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A213209-001	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A213209-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213209-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213209-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213209-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213209-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213209-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213209-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213209-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213209-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213209-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213209-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213209-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213209-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213209-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213209-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213209-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213209-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213209-001	AP	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213209-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213209-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213209-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A213209-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A213209-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A213209-001	AP	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213209-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213209-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213209-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213209-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213209-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213209-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213209-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213209-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213209-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213209-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213209-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213209-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213209-001	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213209-001	AP	1	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2020-12-22 03:56 UTC	2020-12	A213209-001	CGT	2020-09-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A213209-001	CGT	2020-09-14	`c0c555d07b60…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
53ed164c-dd09-4ea4-e063-6294a90a2434	Available on FDA.report

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
NALOXONE HYDROCHLORIDE	NALOXONE HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	53ed164c-dd09-4ea4-e063-6294a90a2434	2026-06-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213209 application number: ANDA213209 ndc (package): 51662-1690-3 ndc (product): 51662-1690 ndc11 (package): 51662169003
Naloxone Hydrochloride	NALOXONE HYDROCHLORIDE	Dr. Reddy's Laboratories, Inc.	b1303f15-c48b-a44d-b28a-72f370094e02	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213209 application number: ANDA213209
NALOXONE HYDROCHLORIDE	NALOXONE HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	c72a60fb-196d-3f02-e053-2995a90ad906	2024-02-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213209 application number: ANDA213209

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	Sample	Exclude flag	Status
51662-1690-3	51662169003	10 POUCH in 1 CASE (51662-1690-3) / 1 BOX in 1 POUCH (51662-1690-2) / 1 SYRINGE in 1 BOX (51662-1690-1) / 2 mL in 1 SYRINGE	10 pouch	2020-03-18	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
NALOXONE HYDROCHLORIDE - HF Acquisition Co LLC, DBA HealthFirst	HF Acquisition Co LLC, DBA HealthFirst	2026-06-11	HUMAN PRESCRIPTION DRUG LABEL	2