Naloxone Hydrochloride

Product NDC
72853-051
11-digit product format
728530051
Labeler code
72853
Product ID
72853-051_9350df83-4185-4905-a293-772803f6b98a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
naloxone hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; SUBCUTANEOUS
Labeler
IJ Therapeutics, LLC
Application
NDA209862
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2019-12-31
Marketing end
2021-09-30
Substance
NALOXONE HYDROCHLORIDE
Active strength
2 mg/.4mL
Pharmacologic classes
Opioid Antagonist [EPC],Opioid Antagonists [MoA]
NDC exclude flag
No
Listing certified through
0000-00-00
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct72853-051DDiscontinued by firm2026-08-17
excluded packagepackage72853-05172853-051-02DDiscontinued by firm2026-08-17

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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage72853-051-02d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage72853-051-02f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage72853-051-022ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage72853-051-02a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage72853-051-02cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage72853-051-02cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage72853-051-02302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage72853-051-02ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage72853-051-020efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage72853-051-02ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage72853-051-02367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage72853-051-02557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N209862-001EVZIO (AUTOINJECTOR)NALOXONE HYDROCHLORIDE2MG/0.4ML (2MG/0.4ML)SOLUTION / INTRAMUSCULAR, SUBCUTANEOUSRLD2016-10-19

Orange Book patents#

Current patent rows page 1 of 1 · 21 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N209862-00192781822026-02-01Drug product2016-11-07
N209862-00189265942026-03-31Drug product2016-11-07
N209862-00177316862026-06-01Drug product2016-11-07
N209862-001109601552026-06-25Drug product2021-04-22
N209862-001115902862026-12-12Drug product2023-03-29
N209862-00192381082027-02-20Drug product2016-11-07
N209862-00182063602027-02-27Drug product2016-11-07
N209862-00197244712027-05-23U-2092Drug product2017-08-23
N209862-00179470172028-03-12Drug product2016-11-07
N209862-00177491942028-10-30Drug product2016-11-07
N209862-00182315732028-11-25Drug product2016-11-07
N209862-00182266102029-04-10Drug product2016-11-07
N209862-00180213442029-11-02Drug product2016-11-07
N209862-001103222392031-02-28U-19072019-06-19
N209862-00189399432031-02-28Drug product2016-11-07
N209862-00190220222031-02-28Drug product2016-11-07
N209862-00194748692031-02-28U-1907Drug product2016-11-07
N209862-001101437922031-05-24U-24762019-01-02
N209862-00186278162032-02-04Drug product2016-11-07
N209862-00195173072034-07-18U-1925Drug product2016-12-19
N209862-001102201582035-03-20U-2500Drug product2019-03-27

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N209862-001EVZIO (AUTOINJECTOR)2MG/0.4ML (2MG/0.4ML)SOLUTION / INTRAMUSCULAR, SUBCUTANEOUSRLD2016-10-19caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N209862-001EVZIO (AUTOINJECTOR)2MG/0.4ML (2MG/0.4ML)SOLUTION / INTRAMUSCULAR, SUBCUTANEOUSRLD2016-10-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209862-001EVZIO (AUTOINJECTOR)2MG/0.4ML (2MG/0.4ML)SOLUTION / INTRAMUSCULAR, SUBCUTANEOUSRLD2016-10-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08N209862-001EVZIO (AUTOINJECTOR)2MG/0.4ML (2MG/0.4ML)SOLUTION / INTRAMUSCULAR, SUBCUTANEOUSRLD2016-10-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N209862-001EVZIO (AUTOINJECTOR)2MG/0.4ML (2MG/0.4ML)SOLUTION / INTRAMUSCULAR, SUBCUTANEOUSRLD2016-10-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N209862-001EVZIO (AUTOINJECTOR)2MG/0.4ML (2MG/0.4ML)SOLUTION / INTRAMUSCULAR, SUBCUTANEOUSRLD2016-10-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N209862-001EVZIO (AUTOINJECTOR)2MG/0.4ML (2MG/0.4ML)SOLUTION / INTRAMUSCULAR, SUBCUTANEOUSRLD2016-10-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N209862-001EVZIO (AUTOINJECTOR)2MG/0.4ML (2MG/0.4ML)SOLUTION / INTRAMUSCULAR, SUBCUTANEOUSRLD2016-10-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N209862-001EVZIO (AUTOINJECTOR)2MG/0.4ML (2MG/0.4ML)SOLUTION / INTRAMUSCULAR, SUBCUTANEOUSRLD2016-10-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N209862-001EVZIO (AUTOINJECTOR)2MG/0.4ML (2MG/0.4ML)SOLUTION / INTRAMUSCULAR, SUBCUTANEOUSRLD2016-10-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N209862-001EVZIO (AUTOINJECTOR)2MG/0.4ML (2MG/0.4ML)SOLUTION / INTRAMUSCULAR, SUBCUTANEOUSRLD2016-10-19d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N209862-001EVZIO (AUTOINJECTOR)2MG/0.4ML (2MG/0.4ML)SOLUTION / INTRAMUSCULAR, SUBCUTANEOUSRLD2016-10-1979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N209862-001EVZIO (AUTOINJECTOR)2MG/0.4ML (2MG/0.4ML)SOLUTION / INTRAMUSCULAR, SUBCUTANEOUSRLD2016-10-19301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N209862-001EVZIO (AUTOINJECTOR)2MG/0.4ML (2MG/0.4ML)SOLUTION / INTRAMUSCULAR, SUBCUTANEOUSRLD2016-10-191e350fbaab3a…
2024-05-31 18:47 UTC2024-05N209862-001EVZIO (AUTOINJECTOR)2MG/0.4ML (2MG/0.4ML)SOLUTION / INTRAMUSCULAR, SUBCUTANEOUSRLD2016-10-198072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N209862-001EVZIO (AUTOINJECTOR)2MG/0.4ML (2MG/0.4ML)SOLUTION / INTRAMUSCULAR, SUBCUTANEOUSRLD2016-10-195c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N209862-001EVZIO (AUTOINJECTOR)2MG/0.4ML (2MG/0.4ML)SOLUTION / INTRAMUSCULAR, SUBCUTANEOUSRLD2016-10-195d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N209862-001EVZIO (AUTOINJECTOR)2MG/0.4ML (2MG/0.4ML)SOLUTION / INTRAMUSCULAR, SUBCUTANEOUSRLD2016-10-194b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N209862-001EVZIO (AUTOINJECTOR)2MG/0.4ML (2MG/0.4ML)SOLUTION / INTRAMUSCULAR, SUBCUTANEOUSRLD, RS2016-10-1974a2ff9319b5…
2022-03-09 01:35 UTC2022-03N209862-001EVZIO (AUTOINJECTOR)2MG/0.4ML (2MG/0.4ML)SOLUTION / INTRAMUSCULAR, SUBCUTANEOUSRLD2016-10-19bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N209862-001EVZIO (AUTOINJECTOR)2MG/0.4ML (2MG/0.4ML)SOLUTION / INTRAMUSCULAR, SUBCUTANEOUSRLD2016-10-19782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N209862-001EVZIO (AUTOINJECTOR)2MG/0.4ML (2MG/0.4ML)SOLUTION / INTRAMUSCULAR, SUBCUTANEOUSRLD2016-10-1987673890dc5c…
2021-03-12 10:30 UTC2021-03N209862-001EVZIO (AUTOINJECTOR)2MG/0.4ML (2MG/0.4ML)SOLUTION / INTRAMUSCULAR, SUBCUTANEOUSRLD2016-10-195aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N209862-001EVZIO (AUTOINJECTOR)2MG/0.4ML (2MG/0.4ML)SOLUTION / INTRAMUSCULAR, SUBCUTANEOUSRLD2016-10-198869cabd3fbd…
2020-11-12 02:37 UTC2020-11N209862-001EVZIO (AUTOINJECTOR)2MG/0.4ML (2MG/0.4ML)SOLUTION / INTRAMUSCULAR, SUBCUTANEOUSRLD2016-10-19c0c555d07b60…
2019-12-14 00:12 UTC2019-12N209862-001EVZIO (AUTOINJECTOR)2MG/0.4ML (2MG/0.4ML)SOLUTION / INTRAMUSCULAR, SUBCUTANEOUSRLD, RS2016-10-193f01610625f2…
2019-09-15 20:21 UTC2019-09N209862-001EVZIO (AUTOINJECTOR)2MG/0.4ML (2MG/0.4ML)SOLUTION / INTRAMUSCULAR, SUBCUTANEOUSRLD, RS2016-10-19b00525d2431f…
2019-07-19 19:46 UTC2019-07N209862-001EVZIO (AUTOINJECTOR)2MG/0.4ML (2MG/0.4ML)SOLUTION / INTRAMUSCULAR, SUBCUTANEOUSRLD, RS2016-10-19ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N209862-001EVZIO (AUTOINJECTOR)2MG/0.4ML (2MG/0.4ML)SOLUTION / INTRAMUSCULAR, SUBCUTANEOUSRLD2016-10-196a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N209862-001EVZIO (AUTOINJECTOR)2MG/0.4ML (2MG/0.4ML)SOLUTION / INTRAMUSCULAR, SUBCUTANEOUSRLD2016-10-191c564ffb4f44…
2023-12-20 04:57 UTC2023-12N209862-001EVZIO (AUTOINJECTOR)2MG/0.4ML (2MG/0.4ML)SOLUTION / INTRAMUSCULAR, SUBCUTANEOUSRLD2016-10-19ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N209862-001EVZIO (AUTOINJECTOR)2MG/0.4ML (2MG/0.4ML)SOLUTION / INTRAMUSCULAR, SUBCUTANEOUSRLD2016-10-19a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N209862-001EVZIO (AUTOINJECTOR)2MG/0.4ML (2MG/0.4ML)SOLUTION / INTRAMUSCULAR, SUBCUTANEOUSRLD2016-10-199b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N209862-001EVZIO (AUTOINJECTOR)2MG/0.4ML (2MG/0.4ML)SOLUTION / INTRAMUSCULAR, SUBCUTANEOUSRLD2016-10-19a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N209862-001EVZIO (AUTOINJECTOR)2MG/0.4ML (2MG/0.4ML)SOLUTION / INTRAMUSCULAR, SUBCUTANEOUSRLD2016-10-193f0d92c62455…
2023-05-13 08:27 UTC2023-05N209862-001EVZIO (AUTOINJECTOR)2MG/0.4ML (2MG/0.4ML)SOLUTION / INTRAMUSCULAR, SUBCUTANEOUSRLD2016-10-19053a50430f4f…
2023-01-26 05:58 UTC2023-01N209862-001EVZIO (AUTOINJECTOR)2MG/0.4ML (2MG/0.4ML)SOLUTION / INTRAMUSCULAR, SUBCUTANEOUSRLD2016-10-193bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N209862-001EVZIO (AUTOINJECTOR)2MG/0.4ML (2MG/0.4ML)SOLUTION / INTRAMUSCULAR, SUBCUTANEOUSRLD2016-10-193a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N209862-001EVZIO (AUTOINJECTOR)2MG/0.4ML (2MG/0.4ML)SOLUTION / INTRAMUSCULAR, SUBCUTANEOUSRLD2016-10-19f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N209862-001EVZIO (AUTOINJECTOR)2MG/0.4ML (2MG/0.4ML)SOLUTION / INTRAMUSCULAR, SUBCUTANEOUSRLD2016-10-19e64feba35796…

Observed Orange Book patent history#

Patent history page 1 of 33 · 1,284 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-18 06:07:402026-07N209862-00192781822026-02-01Drug product2016-11-07caaa826d4ba7…
2026-08-18 06:07:402026-07N209862-00189265942026-03-31Drug product2016-11-07caaa826d4ba7…
2026-08-18 06:07:402026-07N209862-00177316862026-06-01Drug product2016-11-07caaa826d4ba7…
2026-08-18 06:07:402026-07N209862-001109601552026-06-25Drug product2021-04-22caaa826d4ba7…
2026-08-18 06:07:402026-07N209862-001115902862026-12-12Drug product2023-03-29caaa826d4ba7…
2026-08-18 06:07:402026-07N209862-00192381082027-02-20Drug product2016-11-07caaa826d4ba7…
2026-08-18 06:07:402026-07N209862-00182063602027-02-27Drug product2016-11-07caaa826d4ba7…
2026-08-18 06:07:402026-07N209862-00197244712027-05-23U-2092Drug product2017-08-23caaa826d4ba7…
2026-08-18 06:07:402026-07N209862-00179470172028-03-12Drug product2016-11-07caaa826d4ba7…
2026-08-18 06:07:402026-07N209862-00177491942028-10-30Drug product2016-11-07caaa826d4ba7…
2026-08-18 06:07:402026-07N209862-00182315732028-11-25Drug product2016-11-07caaa826d4ba7…
2026-08-18 06:07:402026-07N209862-00182266102029-04-10Drug product2016-11-07caaa826d4ba7…
2026-08-18 06:07:402026-07N209862-00180213442029-11-02Drug product2016-11-07caaa826d4ba7…
2026-08-18 06:07:402026-07N209862-001103222392031-02-28U-19072019-06-19caaa826d4ba7…
2026-08-18 06:07:402026-07N209862-00189399432031-02-28Drug product2016-11-07caaa826d4ba7…
2026-08-18 06:07:402026-07N209862-00190220222031-02-28Drug product2016-11-07caaa826d4ba7…
2026-08-18 06:07:402026-07N209862-00194748692031-02-28U-1907Drug product2016-11-07caaa826d4ba7…
2026-08-18 06:07:402026-07N209862-001101437922031-05-24U-24762019-01-02caaa826d4ba7…
2026-08-18 06:07:402026-07N209862-00186278162032-02-04Drug product2016-11-07caaa826d4ba7…
2026-08-18 06:07:402026-07N209862-00195173072034-07-18U-1925Drug product2016-12-19caaa826d4ba7…
2026-08-18 06:07:402026-07N209862-001102201582035-03-20U-2500Drug product2019-03-27caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N209862-00192781822026-02-01Drug product2016-11-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209862-00189265942026-03-31Drug product2016-11-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209862-00177316862026-06-01Drug product2016-11-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209862-001109601552026-06-25Drug product2021-04-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209862-001115902862026-12-12Drug product2023-03-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209862-00192381082027-02-20Drug product2016-11-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209862-00182063602027-02-27Drug product2016-11-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209862-00197244712027-05-23U-2092Drug product2017-08-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209862-00179470172028-03-12Drug product2016-11-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209862-00177491942028-10-30Drug product2016-11-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209862-00182315732028-11-25Drug product2016-11-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209862-00182266102029-04-10Drug product2016-11-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209862-00180213442029-11-02Drug product2016-11-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209862-001103222392031-02-28U-19072019-06-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209862-00189399432031-02-28Drug product2016-11-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209862-00190220222031-02-28Drug product2016-11-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209862-00194748692031-02-28U-1907Drug product2016-11-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209862-001101437922031-05-24U-24762019-01-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209862-00186278162032-02-04Drug product2016-11-07011fe1cb6892…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72853-051-02ML - Milliliter72853-0511e31e6d8-d0d4-4e6c-9e98-81606002667912020-02-13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72853-051-02728530051022 DOSE PACK in 1 CARTON (72853-051-02) > .4 mL in 1 DOSE PACK2 dose pack2019-12-310000-00-00NoNoCurrent