FDA.reportPublic FDA data

NDC 76329-3469-01 - Naloxone Hydrochloride

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
76329-3469
Requested NDC
76329-3469-01
Package NDCs from labels
76329-3469-1, 76329-3469-01
Manufacturer
REMEDYREPACK INC.
Effective date
2022-02-02
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Naloxone Hydrochloride - REMEDYREPACK INC.REMEDYREPACK INC.2022-02-02HUMAN PRESCRIPTION DRUG LABEL
Naloxone Hydrochloride - International Medication Systems, LimitedInternational Medication Systems, Limited2021-12-13HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76329-3469-1Naloxone Hydrochloride2 mL in 1 SYRINGEINJECTION23
76329-3469-1Naloxone Hydrochloride10 in 1 BOXINJECTION103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76329-3469NALOXONE HYDROCHLORIDE INJECTION [INTERNATIONAL MEDICATION SYSTEMS, LIMITED ]3Current NDC, Legacy NDC, 2 package rows20211216_d2f5bfa0-933e-46d0-8b1a-9f90e6aaba54.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 6 · 101 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Naloxone HydrochlorideNALOXONE HYDROCHLORIDEAmneal Pharmaceuticals LLC8091a73d-9ecd-4578-a57b-5d85a2c5a16a2026-08-25WarningsExact identifier
unii: F850569PQR
NARCANNALOXONE HYDROCHLORIDE NASALEmergent Devices Inc.a0ebc83d-2892-40de-bc0a-775ce90b30db2026-08-17WarningsExact identifier
unii: F850569PQR
Naloxone HydrochlorideNALOXONE HYDROCHLORIDESportpharm LLC3750bf77-342c-4469-8bbb-f71009aa03fa2026-07-02WarningsExact identifier
unii: F850569PQR
Naloxone HydrochlorideNALXONE HYDROCHLORIDECivica, Inc.21d20dff-6efe-481e-a5a0-9c80ded73ca92026-06-30Warnings, Adverse reactionsExact identifier
unii: F850569PQR
BUPRENORPHINE AND NALOXONEBUPRENORPHINE AND NALOXONEAscend Laboratories, LLC2e807ed0-6df3-47b5-b7ee-b421c5bf0aa72026-06-29Warnings, Adverse reactionsExact identifier
unii: F850569PQR
Pentazocine and naloxonePENTAZOCINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEActavis Pharma, Inc.a28450a0-ac93-4235-b9a6-58cdf24773cb2026-06-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: F850569PQR
ZubsolvBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEEdenbridge Pharmaceuticals LLC.57583c1d-9c44-4503-917d-68dba7377bd12026-06-12Warnings, Adverse reactionsExact identifier
unii: F850569PQR
NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirst53ed164c-dd09-4ea4-e063-6294a90a24342026-06-11Warnings, Adverse reactionsExact identifier
rxcui: 1191250
unii: F850569PQR
Naloxone HydrochlorideNALOXONE HYDROCHLORIDEA-S Medication Solutions5906381c-81f4-4635-867a-e56e4d6296922026-06-03Warnings, Adverse reactionsExact identifier
unii: F850569PQR
Naloxone HydrochlorideNALOXONE HYDROCHLORIDEHospira, Inc.8535cc84-ad4a-4d67-8480-fb5a2e3406f82026-05-27Warnings, Adverse reactionsExact identifier
unii: F850569PQR
Naloxone HydrochlorideNALOXONE HYDROCHLORIDESomerset Therapeutics, LLCdfa48492-d83b-48cc-9ad1-bdc0c2ac99312026-05-05Warnings, Adverse reactionsExact identifier
unii: F850569PQR
NARCANNALOXONE HYDROCHLORIDE NASALSportpharm LLC3d43b2a2-9cc3-4c14-8ae7-fea4c83a7f922026-04-24WarningsExact identifier
unii: F850569PQR
Buprenorphine and NaloxoneBUPRENORPHINE AND NALOXONERedpharm Drug5005a6c8-9a3b-a99a-e063-6294a90aac132026-04-22Warnings, Adverse reactionsExact identifier
unii: F850569PQR
Buprenorphine and NaloxoneBUPRENORPHINE AND NALOXONEAveva Drug Delivery Systems Inc.cb112448-49a1-4209-bcdb-7cfae6501f512026-04-07Warnings, Adverse reactionsExact identifier
unii: F850569PQR
NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDEBluePoint Laboratories327004b0-560a-84d0-e063-6294a90aa7432026-04-02WarningsExact identifier
unii: F850569PQR
Buprenorphine and NaloxoneBUPRENORPHINE AND NALOXONEINGENUS PHARMACEUTICALS, LLC4951ec29-609b-4836-b0e4-0d9c1d6ae6fe2026-03-23Warnings, Adverse reactionsExact identifier
unii: F850569PQR
NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDEHF Acquisition Co. LLC. DBA HealthFirst4d66b96a-acbb-2292-e063-6294a90af7882026-03-19Warnings, Adverse reactionsExact identifier
unii: F850569PQR
REZENOPYNALOXONE HCLScienture LLC5bb502aa-014f-4a36-8972-42a9439168fe2026-03-03Warnings, Adverse reactionsExact identifier
unii: F850569PQR
NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDEHenry Schein, Incbd65e3fe-cd7a-4855-8f55-8cc3a0921ccc2026-03-02Warnings, Adverse reactionsExact identifier
application number: ANDA072076
rxcui: 1191250
unii: F850569PQR
Buprenorphine and NaloxoneBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEPAI Holdings, LLC dba PAI Pharmad5b011ef-f1be-47f2-8f8b-07553f36193c2026-02-28Warnings, Adverse reactionsExact identifier
unii: F850569PQR

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.