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 3 of 6 · 101 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirst3ba53405-5e72-c035-e063-6294a90ac0b12025-08-05Warnings, Adverse reactionsExact identifier
unii: F850569PQR
Naloxone HydrochlorideNALOXONE HYDROCHLORIDEFresenius Kabi USA, LLC201fdedf-1736-4e52-9d7d-de14292547fd2025-07-31Warnings, Adverse reactionsExact identifier
rxcui: 1191250
unii: F850569PQR
Naloxone HydrochlorideNALOXONE HYDROCHLORIDEProPharma Distribution3856ea66-29b8-8fc2-e063-6394a90ac33a2025-07-18Warnings, Adverse reactionsExact identifier
unii: F850569PQR
Naloxone HydrochlorideNALOXONE HYDROCHLORIDEEugia US LLC8bcf426a-b4fc-4f24-9ad0-fb26168a0b562025-05-14Warnings, Adverse reactionsExact identifier
rxcui: 1191250
unii: F850569PQR
naloxone hydrochlorideNALOXONE HYDROCHLORIDENorthStar RxLLCd4c44b74-4e36-4b63-80eb-64ce99ccb39f2025-01-27Warnings, Adverse reactionsExact identifier
unii: F850569PQR
Naloxone HydrochlorideNALOXONE HYDROCHLORIDEHenry Schein, Inc.d39635a4-ddb3-4d32-8211-eb84c78e9f592025-01-27Warnings, Adverse reactionsExact identifier
unii: F850569PQR
NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirst9bcff682-1196-7cef-e053-2a95a90aa9542025-01-08Warnings, Adverse reactionsExact identifier
unii: F850569PQR
Naloxone HydrochlorideNALOXONE HYDROCHLORIDEInternational Medication Systems, Limited236349ef-2cb5-47ca-a3a5-99534c3a49962024-12-16Warnings, Adverse reactionsExact identifier
application number: ANDA072076
rxcui: 1191250
unii: F850569PQR
Naloxone HydrochlorideNALOXONE HYDROCHLORIDEMedical Purchasing Solutions, LLC28f3e3bc-b1be-9f06-e063-6394a90a19362024-12-10Warnings, Adverse reactionsExact identifier
unii: F850569PQR
Naloxone HydrochlorideNALOXONE HYDROCHLORIDEAsclemed USA, Inc.7acf3bde-f858-4fbc-8a11-6741a3d27b8e2024-10-29WarningsExact identifier
unii: F850569PQR
naloxone hydrochlorideNALOXONE HYDROCHLORIDEBaxter Healthcare Corporation48137634-91d7-41e3-b54b-e4321d69668a2024-10-04Warnings, Adverse reactionsExact identifier
rxcui: 1191250
unii: F850569PQR
NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDEBryant Ranch Prepacked549649-dcbd-41f7-a774-876906751c5a2024-10-03WarningsExact identifier
unii: F850569PQR
Naloxone HydrochlorideNALOXONE HYDROCHLORIDEEugia US LLCc7fa8d4f-28a7-4ef5-aef8-cbd4328ce5992024-07-06Warnings, Adverse reactionsExact identifier
unii: F850569PQR
NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDEEugia US LLC2725b9c0-5b1e-498b-9ec5-ee76a62e656a2024-07-06Warnings, Adverse reactionsExact identifier
unii: F850569PQR
NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDEAdvanced Rx of Tennessee, LLC1be2e38b-55ca-abea-e063-6394a90ac5482024-06-27WarningsExact identifier
unii: F850569PQR
NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirst19b0603b-241f-f439-e063-6294a90ae85f2024-05-30WarningsExact identifier
unii: F850569PQR
Naloxone HydrochlorideNALOXONE HYDROCHLORIDECVS Pharmacy, Inc840e017d-0142-4d0e-a80e-327ac44bc0c52024-04-24WarningsExact identifier
unii: F850569PQR
Naloxone HydrochlorideNALOXONE HYDROCHLORIDEWalgreen Co.3829826b-e48f-4e26-869f-6b9e4ee0a8402024-04-24WarningsExact identifier
unii: F850569PQR
Naloxone HydrochlorideNALOXONEAmneal Pharmaceuticals NY LLC8779a073-dc6e-410a-9959-fd370f0079f92024-04-19WarningsExact identifier
unii: F850569PQR
Naloxone HydrochlorideNALOXONE HYDROCHLORIDEMylan Institutional LLC7faaedb3-227b-408d-b772-6b326638b00e2024-04-12Warnings, Adverse reactionsExact identifier
rxcui: 1191250
unii: F850569PQR

Reported adverse events (FAERS/openFDA)#

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