Naloxone Hydrochloride

Product NDC: 43598-750
Requested package NDC: 43598-750-58
11-digit product format: 435980750
Labeler code: 43598
Product ID: 43598-750_6558760c-9e5d-caa4-7786-efca221e56f4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Naloxone Hydrochloride
Dosage form: INJECTION
Route: INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler: Dr. Reddy's Laboratories, Inc.
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

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	43598-750	43598-750-58	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
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
2026-02-19 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
2026-02-19 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…`

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
b1303f15-c48b-a44d-b28a-72f370094e02	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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43598-750-10	ML - Milliliter	43598-750	a5587f6e-a4f0-4c6d-897d-01f4edf9ce52	1	2025-02-10
43598-750-11	ML - Milliliter	43598-750	ad8e6325-8934-425c-b594-c1f96873e6e5	1	2020-04-20
43598-750-58	ML - Milliliter	43598-750	491014f9-30bd-4f42-8818-676dc242b836	1	2020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43598-750	NALOXONE HYDROCHLORIDE INJECTION [DR. REDDY'S LABORATORIES, INC.]	7	Current NDC, Legacy NDC	20240912_b1303f15-c48b-a44d-b28a-72f370094e02.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 · 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
Naloxone Hydrochloride	NALOXONE HYDROCHLORIDE	Dr. Reddy's Laboratories, Inc.	b1303f15-c48b-a44d-b28a-72f370094e02	2024-08-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213209 application number: ANDA213209 ndc (package): 43598-750-58 ndc (product): 43598-750 ndc11 (package): 43598075058
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

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	b1303f15-c48b-a44d-b28a-72f370094e02	8
1191250	2 ML naloxone hydrochloride 1 MG/ML Prefilled Syringe	SCD	b1303f15-c48b-a44d-b28a-72f370094e02	8
1191250	naloxone hydrochloride 2 MG per 2 ML Prefilled Syringe	SY	b1303f15-c48b-a44d-b28a-72f370094e02	8
1191250	naloxone HCl 2 MG in 2 ML Prefilled Syringe	PSN	c72a60fb-196d-3f02-e053-2995a90ad906	3
1191250	2 ML naloxone hydrochloride 1 MG/ML Prefilled Syringe	SCD	c72a60fb-196d-3f02-e053-2995a90ad906	3
1191250	naloxone hydrochloride 2 MG per 2 ML Prefilled Syringe	SY	c72a60fb-196d-3f02-e053-2995a90ad906	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
43598-750-58	43598075058	10 SYRINGE in 1 BOX (43598-750-58) > 2 mL in 1 SYRINGE	10 syringe	2020-03-18	0000-00-00	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
Naloxone Hydrochloride - Dr. Reddy's Laboratories, Inc. \| Dr. Reddy's Laboratories Limited-FTO9	Dr. Reddy's Laboratories, Inc. \| Dr. Reddy's Laboratories Limited-FTO9	2024-08-01	HUMAN PRESCRIPTION DRUG LABEL	8
NALOXONE HYDROCHLORIDE INJECTION, USP 2mg/2mL (1mg/mL)	HF Acquisition Co LLC, DBA HealthFirst	2024-02-22	HUMAN PRESCRIPTION DRUG LABEL	3