Naloxone Hydrochloride

Product NDC
17478-042
11-digit product format
174780042
Labeler code
17478
Product ID
17478-042_c169f27e-a661-4482-8303-0a0d4d811655
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naloxone Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler
Akorn
Application
ANDA208872
Marketing category
ANDA
Marketing start
2017-03-14
Marketing end
0000-00-00
Substance
NALOXONE HYDROCHLORIDE
Active strength
0 mg/mL
Pharmacologic classes
Opioid Antagonist [EPC], Opioid Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
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 productproduct17478-042IInactivated by FDA2026-08-11
excluded packagepackage17478-04217478-042-10IInactivated by FDA2026-08-11

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 · 30 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 packagepackage17478-042-10d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage17478-042-10f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage17478-042-102ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage17478-042-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage17478-042-10cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage17478-042-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage17478-042-10302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage17478-042-10ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage17478-042-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage17478-042-10ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage17478-042-10367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage17478-042-10557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage17478-042-108af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage17478-042-10834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage17478-042-101332a3947898…d4bfe170f9cd…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A208872-001NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDE0.4MG/MLINJECTABLE / INJECTIONAP2017-03-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A208872-001AP

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A208872-001NALOXONE HYDROCHLORIDE0.4MG/MLINJECTABLE / INJECTIONAP2017-03-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208872-001NALOXONE HYDROCHLORIDE0.4MG/MLINJECTABLE / INJECTIONAP2017-03-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08A208872-001NALOXONE HYDROCHLORIDE0.4MG/MLINJECTABLE / INJECTIONAP2017-03-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208872-001NALOXONE HYDROCHLORIDE0.4MG/MLINJECTABLE / INJECTIONAP2017-03-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208872-001NALOXONE HYDROCHLORIDE0.4MG/MLINJECTABLE / INJECTIONAP2017-03-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208872-001NALOXONE HYDROCHLORIDE0.4MG/MLINJECTABLE / INJECTIONAP2017-03-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208872-001NALOXONE HYDROCHLORIDE0.4MG/MLINJECTABLE / INJECTIONAP2017-03-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208872-001NALOXONE HYDROCHLORIDE0.4MG/MLINJECTABLE / INJECTIONAP2017-03-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208872-001NALOXONE HYDROCHLORIDE0.4MG/MLINJECTABLE / INJECTIONAP2017-03-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208872-001NALOXONE HYDROCHLORIDE0.4MG/MLINJECTABLE / INJECTIONAP2017-03-14d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208872-001NALOXONE HYDROCHLORIDE0.4MG/MLINJECTABLE / INJECTIONAP2017-03-1479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208872-001NALOXONE HYDROCHLORIDE0.4MG/MLINJECTABLE / INJECTIONAP2017-03-14301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208872-001NALOXONE HYDROCHLORIDE0.4MG/MLINJECTABLE / INJECTIONAP2017-03-141e350fbaab3a…
2024-05-31 18:47 UTC2024-05A208872-001NALOXONE HYDROCHLORIDE0.4MG/MLINJECTABLE / INJECTIONAP2017-03-148072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208872-001NALOXONE HYDROCHLORIDE0.4MG/MLINJECTABLE / INJECTIONAP2017-03-145c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A208872-001NALOXONE HYDROCHLORIDE0.4MG/MLINJECTABLE / INJECTIONAP2017-03-145d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A208872-001NALOXONE HYDROCHLORIDE0.4MG/MLINJECTABLE / INJECTIONAP2017-03-144b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A208872-001NALOXONE HYDROCHLORIDE0.4MG/MLINJECTABLE / INJECTIONAP2017-03-1474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A208872-001NALOXONE HYDROCHLORIDE0.4MG/MLINJECTABLE / INJECTIONAP2017-03-14bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A208872-001NALOXONE HYDROCHLORIDE0.4MG/MLINJECTABLE / INJECTIONAP2017-03-14782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A208872-001NALOXONE HYDROCHLORIDE0.4MG/MLINJECTABLE / INJECTIONAP2017-03-1487673890dc5c…
2021-03-12 10:30 UTC2021-03A208872-001NALOXONE HYDROCHLORIDE0.4MG/MLINJECTABLE / INJECTIONAP2017-03-145aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A208872-001NALOXONE HYDROCHLORIDE0.4MG/MLINJECTABLE / INJECTIONAP2017-03-148869cabd3fbd…
2020-11-12 02:37 UTC2020-11A208872-001NALOXONE HYDROCHLORIDE0.4MG/MLINJECTABLE / INJECTIONAP2017-03-14c0c555d07b60…
2019-12-14 00:12 UTC2019-12A208872-001NALOXONE HYDROCHLORIDE0.4MG/MLINJECTABLE / INJECTIONAP2017-03-143f01610625f2…
2019-09-15 20:21 UTC2019-09A208872-001NALOXONE HYDROCHLORIDE0.4MG/MLINJECTABLE / INJECTIONAP2017-03-14b00525d2431f…
2019-07-19 19:46 UTC2019-07A208872-001NALOXONE HYDROCHLORIDE0.4MG/MLINJECTABLE / INJECTIONAP2017-03-14ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A208872-001NALOXONE HYDROCHLORIDE0.4MG/MLINJECTABLE / INJECTIONAP2017-03-146a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A208872-001NALOXONE HYDROCHLORIDE0.4MG/MLINJECTABLE / INJECTIONAP2017-03-141c564ffb4f44…
2023-12-20 04:57 UTC2023-12A208872-001NALOXONE HYDROCHLORIDE0.4MG/MLINJECTABLE / INJECTIONAP2017-03-14ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A208872-001NALOXONE HYDROCHLORIDE0.4MG/MLINJECTABLE / INJECTIONAP2017-03-14a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A208872-001NALOXONE HYDROCHLORIDE0.4MG/MLINJECTABLE / INJECTIONAP2017-03-149b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A208872-001NALOXONE HYDROCHLORIDE0.4MG/MLINJECTABLE / INJECTIONAP2017-03-14a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A208872-001NALOXONE HYDROCHLORIDE0.4MG/MLINJECTABLE / INJECTIONAP2017-03-143f0d92c62455…
2023-05-13 08:27 UTC2023-05A208872-001NALOXONE HYDROCHLORIDE0.4MG/MLINJECTABLE / INJECTIONAP2017-03-14053a50430f4f…
2023-01-26 05:58 UTC2023-01A208872-001NALOXONE HYDROCHLORIDE0.4MG/MLINJECTABLE / INJECTIONAP2017-03-143bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A208872-001NALOXONE HYDROCHLORIDE0.4MG/MLINJECTABLE / INJECTIONAP2017-03-143a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A208872-001NALOXONE HYDROCHLORIDE0.4MG/MLINJECTABLE / INJECTIONAP2017-03-14f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A208872-001NALOXONE HYDROCHLORIDE0.4MG/MLINJECTABLE / INJECTIONAP2017-03-14e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A208872-001NALOXONE HYDROCHLORIDE0.4MG/MLINJECTABLE / INJECTIONAP2017-03-14cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A208872-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208872-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A208872-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208872-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208872-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208872-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208872-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208872-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208872-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208872-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208872-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208872-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208872-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A208872-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208872-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A208872-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A208872-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A208872-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A208872-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A208872-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A208872-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A208872-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A208872-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A208872-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A208872-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09A208872-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A208872-001AP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A208872-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A208872-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A208872-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A208872-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A208872-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A208872-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A208872-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05A208872-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01A208872-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A208872-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A208872-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A208872-001AP1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A208872-001AP1cb3db0bc1861…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c955d208-c333-9bd7-be34-d7e12986d44eProduct name620250626
e5f98bfa-66d5-4c3a-b22d-9543d3bee304Product name120250204
caa6391e-3db3-c912-335f-61b5fc00aa12Product name920240110
65a3bc34-04ff-4cf1-aad9-c7d92a062f6dProduct name120231003
e951cdf3-f269-4d97-a7d5-c1c3d7283a7dProduct name320230313
ab841ac7-728a-4fc9-be0a-35b96cecbf39Product name420230306
f327b80c-8fa2-404b-838a-df3eec141cf2Product name120221212
d4aa2fcf-79c3-4b5f-a00e-1a8e26e00119Product name120220511
b871fccd-1de6-4c7f-b9e5-045304641ee6Product name820220118
43b1efe2-1425-4b3e-b3a2-57d40f8478b9Product name120211026
4c23a34c-e8fc-424c-8fa0-ee064ba6eaefProduct name120170706
0b8c7273-1da3-495f-909a-7cf1e96d2361Product name120161212
3df867ed-9d48-45cf-bded-1394beaea0b1Product name320161206
8a245632-e24f-4ccc-b671-995d89c96ebcProduct name120141203

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
17478-042-102024-01-30C16284748780-11030e365-6971-111a-e063-dadaa90a10e2Naloxone Hydrochloride Injection, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17478-042-10Naloxone Hydrochloride10 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION1012
17478-042-10Naloxone Hydrochloride1 in 1 CARTONINJECTION, SOLUTION112

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17478-042-10ML - Milliliter17478-0429b7fbb6a-9414-421d-b92e-592e81d8156712017-09-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17478-042NALOXONE HYDROCHLORIDE INJECTION, SOLUTION [AKORN]12Legacy NDC, 2 package rows20220915_747e602c-93f9-4723-a899-4c1c55c35ef8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1659929naloxone HCl 0.4 MG in 1 ML InjectionPSN747e602c-93f9-4723-a899-4c1c55c35ef812
1191222naloxone HCl 0.4 MG/ML Injectable SolutionPSN747e602c-93f9-4723-a899-4c1c55c35ef812
16599291 ML naloxone hydrochloride 0.4 MG/ML InjectionSCD747e602c-93f9-4723-a899-4c1c55c35ef812
1191222naloxone hydrochloride 0.4 MG/ML Injectable SolutionSCD747e602c-93f9-4723-a899-4c1c55c35ef812
1659929naloxone HCl 0.4 MG per 1 ML InjectionSY747e602c-93f9-4723-a899-4c1c55c35ef812

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
17478-042-10174780042101 VIAL, MULTI-DOSE in 1 CARTON (17478-042-10) > 10 mL in 1 VIAL, MULTI-DOSE2017-03-140000-00-00NoNoCurrent