FDA.reportPublic FDA data

NALOXONE HYDROCHLORIDE

Product NDC
45802-811
11-digit product format
458020811
Labeler code
45802
Product ID
45802-811_29fa6170-7b01-48a2-9e55-e213325e2d25
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
naloxone hydrochloride
Dosage form
SPRAY
Route
NASAL
Labeler
Padagis Israel Pharmaceuticals Ltd
Application
ANDA211951
Marketing category
ANDA
Marketing start
2022-06-21
Marketing end
0000-00-00
Substance
NALOXONE HYDROCHLORIDE
Active strength
4 mg/.1mL
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 productproduct45802-811DDiscontinued by firm2026-08-11
excluded packagepackage45802-81145802-811-84DDiscontinued by firm2026-08-11

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproduct45802-811DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage45802-81145802-811-84DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

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
A211951-001NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDE4MG/SPRAYSPRAY, METERED / NASAL2022-06-21

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A211951-001NALOXONE HYDROCHLORIDE4MG/SPRAYSPRAY, METERED / NASAL2022-06-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211951-001NALOXONE HYDROCHLORIDE4MG/SPRAYSPRAY, METERED / NASAL2022-06-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A211951-001NALOXONE HYDROCHLORIDE4MG/SPRAYSPRAY, METERED / NASAL2022-06-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211951-001NALOXONE HYDROCHLORIDE4MG/SPRAYSPRAY, METERED / NASAL2022-06-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211951-001NALOXONE HYDROCHLORIDE4MG/SPRAYSPRAY, METERED / NASAL2022-06-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211951-001NALOXONE HYDROCHLORIDE4MG/SPRAYSPRAY, METERED / NASAL2022-06-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211951-001NALOXONE HYDROCHLORIDE4MG/SPRAYSPRAY, METERED / NASAL2022-06-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211951-001NALOXONE HYDROCHLORIDE4MG/SPRAYSPRAY, METERED / NASAL2022-06-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211951-001NALOXONE HYDROCHLORIDE4MG/SPRAYSPRAY, METERED / NASAL2022-06-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211951-001NALOXONE HYDROCHLORIDE4MG/SPRAYSPRAY, METERED / NASAL2022-06-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211951-001NALOXONE HYDROCHLORIDE4MG/SPRAYSPRAY, METERED / NASAL2022-06-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211951-001NALOXONE HYDROCHLORIDE4MG/SPRAYSPRAY, METERED / NASAL2022-06-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211951-001NALOXONE HYDROCHLORIDE4MG/SPRAYSPRAY, METERED / NASAL2022-06-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211951-001NALOXONE HYDROCHLORIDE4MG/SPRAYSPRAY, METERED / NASAL2022-06-218072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A211951-001NALOXONE HYDROCHLORIDE4MG/SPRAYSPRAY, METERED / NASAL2022-06-216a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A211951-001NALOXONE HYDROCHLORIDE4MG/SPRAYSPRAY, METERED / NASAL2022-06-211c564ffb4f44…
2023-12-20 04:57 UTC2023-12A211951-001NALOXONE HYDROCHLORIDE4MG/SPRAYSPRAY, METERED / NASAL2022-06-21ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A211951-001NALOXONE HYDROCHLORIDE4MG/SPRAYSPRAY, METERED / NASAL2022-06-21a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A211951-001NALOXONE HYDROCHLORIDE4MG/SPRAYSPRAY, METERED / NASAL2022-06-219b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A211951-001NALOXONE HYDROCHLORIDE4MG/SPRAYSPRAY, METERED / NASALAB2022-06-21a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A211951-001NALOXONE HYDROCHLORIDE4MG/SPRAYSPRAY, METERED / NASALAB2022-06-213f0d92c62455…
2023-05-13 08:27 UTC2023-05A211951-001NALOXONE HYDROCHLORIDE4MG/SPRAYSPRAY, METERED / NASALAB2022-06-21053a50430f4f…
2023-01-26 05:58 UTC2023-01A211951-001NALOXONE HYDROCHLORIDE4MG/SPRAYSPRAY, METERED / NASALAB2022-06-213bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A211951-001NALOXONE HYDROCHLORIDE4MG/SPRAYSPRAY, METERED / NASALAB2022-06-213a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A211951-001NALOXONE HYDROCHLORIDE4MG/SPRAYSPRAY, METERED / NASALAB2022-06-21f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A211951-001NALOXONE HYDROCHLORIDE4MG/SPRAYSPRAY, METERED / NASALAB2022-06-21e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A211951-001NALOXONE HYDROCHLORIDE4MG/SPRAYSPRAY, METERED / NASALAB2022-06-21cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211951-001NALOXONE HYDROCHLORIDE4MG/SPRAYSPRAY, METERED / NASAL2022-06-21a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A211951-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A211951-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A211951-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A211951-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A211951-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A211951-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A211951-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A211951-001AB1cb3db0bc1861…

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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
65a3bc34-04ff-4cf1-aad9-c7d92a062f6dProduct name120231003
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
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
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
4c23a34c-e8fc-424c-8fa0-ee064ba6eaefProduct name120170706
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
0b8c7273-1da3-495f-909a-7cf1e96d2361Product name120161212
3df867ed-9d48-45cf-bded-1394beaea0b1Product name320161206
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
8a245632-e24f-4ccc-b671-995d89c96ebcProduct name120141203
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45802-811-00EA - Each45802-8112584cf2b-1ccf-4b35-8860-0a02bab3901a12022-07-06
45802-811-84EA - Each45802-811bd196d34-6b1d-493f-85b8-ffb1be112ee712022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45802-811NALOXONE HYDROCHLORIDE SPRAY [PADAGIS ISRAEL PHARMACEUTICALS LTD]3Legacy NDC20241027_29fa6170-7b01-48a2-9e55-e213325e2d25.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 · 11 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDEBluePoint Laboratories327004b0-560a-84d0-e063-6294a90aa7432026-04-02WarningsExact identifier
application applno (ANDA): 211951
application number: ANDA211951
NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDEPadagis Israel Pharmaceuticals Ltdb5d40220-f194-4835-b70c-f304ecb222d52026-01-06WarningsExact identifier
application applno (ANDA): 211951
application number: ANDA211951
NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDEStrategic Sourcing Services LLC577fbd57-7054-4536-86c1-d43bc99cc7b12025-11-19WarningsExact identifier
application applno (ANDA): 211951
application number: ANDA211951
NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDEAMERISOURCE BERGENcce38c13-0d2f-49bb-94fa-6f2bbb4d59842025-08-31WarningsExact identifier
application applno (ANDA): 211951
application number: ANDA211951
NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDEBryant Ranch Prepacked549649-dcbd-41f7-a774-876906751c5a2024-10-03WarningsExact identifier
application applno (ANDA): 211951
application number: ANDA211951
NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDEAdvanced Rx of Tennessee, LLC1be2e38b-55ca-abea-e063-6394a90ac5482024-06-27WarningsExact identifier
application applno (ANDA): 211951
application number: ANDA211951
NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirst19b0603b-241f-f439-e063-6294a90ae85f2024-05-30WarningsExact identifier
application applno (ANDA): 211951
application number: ANDA211951
NALOXONE HClNALOXONE HCLHF Acquisition Co LLC, DBA HealthFirstf8fcda15-8ba6-e66a-e053-6294a90a385c2024-01-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211951
application number: ANDA211951
NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDEA-S Medication Solutions46f27d04-d4d2-4ef1-9cc5-4d58f4056f062023-12-27WarningsExact identifier
application applno (ANDA): 211951
application number: ANDA211951
NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDEA-S Medication Solutions0b3b5214-6f91-4bba-82d6-d57b16845df52023-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211951
application number: ANDA211951
NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDEProficient Rx LP8d529b4c-85fd-4e50-9443-9080825307bf2022-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211951
application number: ANDA211951

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1725059naloxone HCl 4 MG in 0.1 ML Nasal SprayPSNf8fcda15-8ba6-e66a-e053-6294a90a385c2
1725059naloxone hydrochloride 40 MG/ML Nasal SpraySCDf8fcda15-8ba6-e66a-e053-6294a90a385c2
1725059naloxone HCl 4 MG per 0.1 ML Nasal SpraySYf8fcda15-8ba6-e66a-e053-6294a90a385c2
1725059naloxone HCl 4 MG in 0.1 ML Nasal SprayPSN0b3b5214-6f91-4bba-82d6-d57b16845df51
1725059naloxone HCl 4 MG in 0.1 ML Nasal SprayPSN1e04b8aa-2363-34cd-e063-6394a90aa3f51
1725059naloxone HCl 4 MG in 0.1 ML Nasal SprayPSN8d529b4c-85fd-4e50-9443-9080825307bf1
1725059naloxone hydrochloride 40 MG/ML Nasal SpraySCD0b3b5214-6f91-4bba-82d6-d57b16845df51
1725059naloxone hydrochloride 40 MG/ML Nasal SpraySCD1e04b8aa-2363-34cd-e063-6394a90aa3f51
1725059naloxone hydrochloride 40 MG/ML Nasal SpraySCD8d529b4c-85fd-4e50-9443-9080825307bf1
1725059naloxone HCl 4 MG per 0.1 ML Nasal SpraySY0b3b5214-6f91-4bba-82d6-d57b16845df51
1725059naloxone HCl 4 MG per 0.1 ML Nasal SpraySY1e04b8aa-2363-34cd-e063-6394a90aa3f51
1725059naloxone HCl 4 MG per 0.1 ML Nasal SpraySY8d529b4c-85fd-4e50-9443-9080825307bf1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
45802-811-84458020811842 VIAL, SINGLE-DOSE in 1 CARTON (45802-811-84) > .1 mL in 1 VIAL, SINGLE-DOSE (45802-811-00) 2022-06-210000-00-00NoNoCurrent