Naloxone Hydrochloride

Product NDC: 0641-6193
11-digit product format: 006416193
Labeler code: 0641
Product ID: 0641-6193_2f3fbff5-628a-49f6-9867-06c876742876
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Naloxone Hydrochloride
Dosage form: INJECTION
Route: INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler: Hikma Pharmaceuticals USA Inc.
Application: ANDA212300
Marketing category: ANDA
Marketing start: 2025-07-25
Substance: NALOXONE HYDROCHLORIDE
Active strength: .4 mg/mL
Pharmacologic classes: Opioid Antagonist [EPC], Opioid Antagonists [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A212300-001	NALOXONE HYDROCHLORIDE	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP		2022-06-10
A212300-002	NALOXONE HYDROCHLORIDE	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP		2024-03-07

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A212300-001	AP
A212300-002	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 · 43 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	A212300-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2022-06-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212300-002	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2024-03-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212300-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2022-06-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212300-002	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2024-03-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212300-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2022-06-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212300-002	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2024-03-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212300-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2022-06-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212300-002	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2024-03-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212300-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2022-06-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212300-002	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2024-03-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212300-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2022-06-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212300-002	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2024-03-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212300-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2022-06-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212300-002	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2024-03-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212300-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2022-06-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212300-002	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2024-03-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212300-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2022-06-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212300-002	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2024-03-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212300-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2022-06-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212300-002	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2024-03-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212300-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2022-06-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212300-002	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2024-03-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212300-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2022-06-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212300-002	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2024-03-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212300-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2022-06-10	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212300-002	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2024-03-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212300-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2022-06-10	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A212300-002	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2024-03-07	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212300-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2022-06-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212300-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2022-06-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212300-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2022-06-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212300-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2022-06-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212300-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2022-06-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212300-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2022-06-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212300-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2022-06-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212300-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2022-06-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212300-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2022-06-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212300-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2022-06-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212300-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2022-06-10	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212300-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2022-06-10	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 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	A212300-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212300-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212300-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212300-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212300-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212300-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212300-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212300-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212300-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212300-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212300-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212300-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212300-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212300-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212300-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212300-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212300-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212300-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212300-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212300-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212300-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212300-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212300-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212300-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212300-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212300-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212300-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A212300-002	AP	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212300-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212300-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212300-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212300-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212300-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212300-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212300-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212300-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212300-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212300-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212300-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212300-001	AP	1	`e64feba35796…`

Additional Listing Data#

Finished product: Yes
Brand name base: Naloxone Hydrochloride
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NALOXONE HYDROCHLORIDE	.4 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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1191250	Internal RxNorm lookup
2679504	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
e6467385-6990-498c-8a0e-f4a40ef33cb7	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 Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0641-6193-01	Naloxone Hydrochloride	1 mL in 1 SYRINGE	INJECTION	1		7
0641-6193-10	Naloxone Hydrochloride	10 in 1 CARTON	INJECTION	10		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0641-6193-01	ML - Milliliter	0641-6193	d8d0b59a-cacf-4759-a725-0044e570daa9	1	2025-09-12
0641-6193-10	ML - Milliliter	0641-6193	88f68b6e-f2ee-4cf5-91ce-bd54086ca5ba	1	2025-09-12

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	Hikma Pharmaceuticals USA Inc.	e6467385-6990-498c-8a0e-f4a40ef33cb7	2025-09-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212300 application number: ANDA212300 ndc (product): 0641-6193

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	e6467385-6990-498c-8a0e-f4a40ef33cb7	7
2679504	naloxone hydrochloride 0.4 MG in 1 ML Prefilled Syringe	PSN	e6467385-6990-498c-8a0e-f4a40ef33cb7	7
2679504	1 ML naloxone hydrochloride 0.4 MG/ML Prefilled Syringe	SCD	e6467385-6990-498c-8a0e-f4a40ef33cb7	7
1191250	2 ML naloxone hydrochloride 1 MG/ML Prefilled Syringe	SCD	e6467385-6990-498c-8a0e-f4a40ef33cb7	7
2679504	naloxone hydrochloride 0.4 MG per 1 ML Prefilled Syringe	SY	e6467385-6990-498c-8a0e-f4a40ef33cb7	7
1191250	naloxone hydrochloride 2 MG per 2 ML Prefilled Syringe	SY	e6467385-6990-498c-8a0e-f4a40ef33cb7	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
0641-6193-01	00641619301	1 mL in 1 SYRINGE	1 ml				Historical
0641-6193-10	00641619310	10 SYRINGE in 1 CARTON (0641-6193-10) / 1 mL in 1 SYRINGE (0641-6193-01)	10 syringe	2025-08-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Naloxone Hydrochloride Injection, USP	Hikma Pharmaceuticals USA Inc.	2025-09-02	HUMAN PRESCRIPTION DRUG LABEL	7