Naloxone Hydrochloride Injection, USP, Auto-Injector

Product NDC: 60842-002
11-digit product format: 608420002
Labeler code: 60842
Product ID: 60842-002_04afe7f9-83ba-4269-a6ce-3bcc61a106d8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Naloxone Hydrochloride
Dosage form: INJECTION, SOLUTION
Route: INTRAMUSCULAR; SUBCUTANEOUS
Labeler: Kaleo, Inc.
Application: NDA215457
Marketing category: NDA
Marketing start: 2022-02-28
Substance: NALOXONE HYDROCHLORIDE
Active strength: 10 mg/.4mL
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N215457-001	NALOXONE HYDROCHLORIDE (AUTOINJECTOR)	NALOXONE HYDROCHLORIDE	10MG/0.4ML (10MG/0.4ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS		RLD	2022-02-28

Orange Book patents#

Current patent rows page 1 of 1 · 6 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N215457-001	10322239	2031-02-28	U-1907		2022-03-25
N215457-001	8939943	2031-02-28		Drug product	2022-03-25
N215457-001	9022022	2031-02-28		Drug product	2022-03-25
N215457-001	9474869	2031-02-28	U-1907	Drug product	2022-03-25
N215457-001	9814838	2031-02-28		Drug product	2022-03-25
N215457-001	10143792	2031-05-24	U-2476		2022-03-25

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	N215457-001	NALOXONE HYDROCHLORIDE (AUTOINJECTOR)	10MG/0.4ML (10MG/0.4ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD	2022-02-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215457-001	NALOXONE HYDROCHLORIDE (AUTOINJECTOR)	10MG/0.4ML (10MG/0.4ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD	2022-02-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215457-001	NALOXONE HYDROCHLORIDE (AUTOINJECTOR)	10MG/0.4ML (10MG/0.4ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD	2022-02-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215457-001	NALOXONE HYDROCHLORIDE (AUTOINJECTOR)	10MG/0.4ML (10MG/0.4ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD	2022-02-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215457-001	NALOXONE HYDROCHLORIDE (AUTOINJECTOR)	10MG/0.4ML (10MG/0.4ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD	2022-02-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215457-001	NALOXONE HYDROCHLORIDE (AUTOINJECTOR)	10MG/0.4ML (10MG/0.4ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD	2022-02-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215457-001	NALOXONE HYDROCHLORIDE (AUTOINJECTOR)	10MG/0.4ML (10MG/0.4ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD	2022-02-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215457-001	NALOXONE HYDROCHLORIDE (AUTOINJECTOR)	10MG/0.4ML (10MG/0.4ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD	2022-02-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215457-001	NALOXONE HYDROCHLORIDE (AUTOINJECTOR)	10MG/0.4ML (10MG/0.4ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD	2022-02-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N215457-001	NALOXONE HYDROCHLORIDE (AUTOINJECTOR)	10MG/0.4ML (10MG/0.4ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD	2022-02-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215457-001	NALOXONE HYDROCHLORIDE (AUTOINJECTOR)	10MG/0.4ML (10MG/0.4ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD	2022-02-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215457-001	NALOXONE HYDROCHLORIDE (AUTOINJECTOR)	10MG/0.4ML (10MG/0.4ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD	2022-02-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N215457-001	NALOXONE HYDROCHLORIDE (AUTOINJECTOR)	10MG/0.4ML (10MG/0.4ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD	2022-02-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N215457-001	NALOXONE HYDROCHLORIDE (AUTOINJECTOR)	10MG/0.4ML (10MG/0.4ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD	2022-02-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N215457-001	NALOXONE HYDROCHLORIDE (AUTOINJECTOR)	10MG/0.4ML (10MG/0.4ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD	2022-02-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N215457-001	NALOXONE HYDROCHLORIDE (AUTOINJECTOR)	10MG/0.4ML (10MG/0.4ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD, RS	2022-02-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N215457-001	NALOXONE HYDROCHLORIDE (AUTOINJECTOR)	10MG/0.4ML (10MG/0.4ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD, RS	2022-02-28	`4b0b4de00fa7…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N215457-001	NALOXONE HYDROCHLORIDE (AUTOINJECTOR)	10MG/0.4ML (10MG/0.4ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD	2022-02-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N215457-001	NALOXONE HYDROCHLORIDE (AUTOINJECTOR)	10MG/0.4ML (10MG/0.4ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD	2022-02-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N215457-001	NALOXONE HYDROCHLORIDE (AUTOINJECTOR)	10MG/0.4ML (10MG/0.4ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD	2022-02-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N215457-001	NALOXONE HYDROCHLORIDE (AUTOINJECTOR)	10MG/0.4ML (10MG/0.4ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD	2022-02-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N215457-001	NALOXONE HYDROCHLORIDE (AUTOINJECTOR)	10MG/0.4ML (10MG/0.4ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD	2022-02-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N215457-001	NALOXONE HYDROCHLORIDE (AUTOINJECTOR)	10MG/0.4ML (10MG/0.4ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD	2022-02-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N215457-001	NALOXONE HYDROCHLORIDE (AUTOINJECTOR)	10MG/0.4ML (10MG/0.4ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD	2022-02-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N215457-001	NALOXONE HYDROCHLORIDE (AUTOINJECTOR)	10MG/0.4ML (10MG/0.4ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD	2022-02-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N215457-001	NALOXONE HYDROCHLORIDE (AUTOINJECTOR)	10MG/0.4ML (10MG/0.4ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD	2022-02-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N215457-001	NALOXONE HYDROCHLORIDE (AUTOINJECTOR)	10MG/0.4ML (10MG/0.4ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD	2022-02-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N215457-001	NALOXONE HYDROCHLORIDE (AUTOINJECTOR)	10MG/0.4ML (10MG/0.4ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD	2022-02-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N215457-001	NALOXONE HYDROCHLORIDE (AUTOINJECTOR)	10MG/0.4ML (10MG/0.4ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD	2022-02-28	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N215457-001	NALOXONE HYDROCHLORIDE (AUTOINJECTOR)	10MG/0.4ML (10MG/0.4ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD	2022-02-28	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N215457-001	NALOXONE HYDROCHLORIDE (AUTOINJECTOR)	10MG/0.4ML (10MG/0.4ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD	2022-02-28	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 13 · 497 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	N215457-001	10322239	2031-02-28	U-1907		2022-03-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215457-001	8939943	2031-02-28		Drug product	2022-03-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215457-001	9022022	2031-02-28		Drug product	2022-03-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215457-001	9474869	2031-02-28	U-1907	Drug product	2022-03-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215457-001	9814838	2031-02-28		Drug product	2022-03-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215457-001	10143792	2031-05-24	U-2476		2022-03-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215457-001	10322239	2031-02-28	U-1907		2022-03-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215457-001	8939943	2031-02-28		Drug product	2022-03-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215457-001	9022022	2031-02-28		Drug product	2022-03-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215457-001	9474869	2031-02-28	U-1907	Drug product	2022-03-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215457-001	9814838	2031-02-28		Drug product	2022-03-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215457-001	10143792	2031-05-24	U-2476		2022-03-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215457-001	10322239	2031-02-28	U-1907		2022-03-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215457-001	8939943	2031-02-28		Drug product	2022-03-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215457-001	9022022	2031-02-28		Drug product	2022-03-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215457-001	9474869	2031-02-28	U-1907	Drug product	2022-03-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215457-001	9814838	2031-02-28		Drug product	2022-03-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215457-001	10143792	2031-05-24	U-2476		2022-03-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215457-001	7731690	2025-01-15		Drug product	2022-03-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215457-001	8016788	2025-03-21		Drug product	2022-03-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215457-001	10335549	2025-04-30		Drug product	2022-03-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215457-001	11590286	2026-12-12		Drug product	2023-03-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215457-001	7947017	2028-03-12		Drug product	2022-03-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215457-001	10322239	2031-02-28	U-1907		2022-03-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215457-001	8939943	2031-02-28		Drug product	2022-03-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215457-001	9022022	2031-02-28		Drug product	2022-03-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215457-001	9474869	2031-02-28	U-1907	Drug product	2022-03-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215457-001	9814838	2031-02-28		Drug product	2022-03-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215457-001	10143792	2031-05-24	U-2476		2022-03-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215457-001	7731690	2025-01-15		Drug product	2022-03-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215457-001	8016788	2025-03-21		Drug product	2022-03-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215457-001	10335549	2025-04-30		Drug product	2022-03-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215457-001	11590286	2026-12-12		Drug product	2023-03-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215457-001	7947017	2028-03-12		Drug product	2022-03-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215457-001	10322239	2031-02-28	U-1907		2022-03-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215457-001	8939943	2031-02-28		Drug product	2022-03-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215457-001	9022022	2031-02-28		Drug product	2022-03-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215457-001	9474869	2031-02-28	U-1907	Drug product	2022-03-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215457-001	9814838	2031-02-28		Drug product	2022-03-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215457-001	10143792	2031-05-24	U-2476		2022-03-25	`b8a1b40f171c…`

Additional Listing Data#

Finished product: Yes
Brand name base: Naloxone Hydrochloride Injection, USP, Auto-Injector
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NALOXONE HYDROCHLORIDE	10 mg/.4mL

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
2596175	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
b5463553-b775-47a3-8d10-31e01ca1ec72	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
60842-002-02	Naloxone Hydrochloride Injection, USP, Auto-Injector	0.4 mL in 1 DOSE PACK	INJECTION, SOLUTION	0.4		2
60842-002-02	Naloxone Hydrochloride Injection, USP, Auto-Injector	10 in 1 CARTON	INJECTION, SOLUTION	10		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60842-002	NALOXONE HYDROCHLORIDE INJECTION, USP, AUTO-INJECTOR (NALOXONE HYDROCHLORIDE) INJECTION, SOLUTION [KALEO, INC.]	2	Current NDC, Legacy NDC, 2 package rows	20220315_b5463553-b775-47a3-8d10-31e01ca1ec72.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 Injection, USP, Auto-Injector	NALOXONE HYDROCHLORIDE	Kaleo, Inc.	b5463553-b775-47a3-8d10-31e01ca1ec72	2022-03-11	Warnings, Adverse reactions	Exact identifier application applno (NDA): 215457 application number: NDA215457 ndc (product): 60842-002

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
2596175	naloxone HCl 10 MG in 0.4 ML Auto-Injector	PSN	b5463553-b775-47a3-8d10-31e01ca1ec72	2
2596175	0.4 ML naloxone hydrochloride 25 MG/ML Auto-Injector	SCD	b5463553-b775-47a3-8d10-31e01ca1ec72	2
2596175	naloxone HCl 10 MG per 0.4 ML Auto-Injector	SY	b5463553-b775-47a3-8d10-31e01ca1ec72	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
60842-002-02	60842000202	10 DOSE PACK in 1 CARTON (60842-002-02) / .4 mL in 1 DOSE PACK	10 dose pack	2022-02-28	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Naloxone Hydrochloride Injection, USP, Auto-Injector	Kaleo, Inc.	2022-03-11	HUMAN PRESCRIPTION DRUG LABEL	2