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 5 of 6 · 101 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Naloxone HydrochlorideNALOXONE HYDROCHLORIDEA-S Medication Solutions3d2dcee4-7510-477b-95a8-9b2afb7739842023-05-23Warnings, Adverse reactionsExact identifier
unii: F850569PQR
Naloxone HydrochlorideNALOXONE HYDROCHLORIDEMedical Purchasing Solutions, LLC958577c3-d2c4-26ad-e053-2a95a90ad73a2023-05-15Warnings, Adverse reactionsExact identifier
application number: ANDA072076
rxcui: 1191250
unii: F850569PQR
Naloxone HydrochlorideNALOXONE HYDROCHLORIDEMedical Purchasing Solutions, LLC9e53f169-4a6e-6102-e053-2995a90ab3dc2023-05-09Warnings, Adverse reactionsExact identifier
unii: F850569PQR
NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDEMedical Purchasing Solutions, LLCada6856c-5293-fc2f-e053-2995a90a8ec62023-05-03Warnings, Adverse reactionsExact identifier
unii: F850569PQR
Naloxone HydrochlorideNALOXONE HYDROCHLORIDEMedical Purchasing Solutions, LLCb621239f-0bbb-7d07-e053-2a95a90a287e2023-04-26Warnings, Adverse reactionsExact identifier
unii: F850569PQR
Naloxone HydrochlorideNALXONE HYDROCHLORIDEMedical Purchasing Solutions, LLC8959171f-eda6-158c-e053-2995a90a36b22023-04-26Warnings, Adverse reactionsExact identifier
unii: F850569PQR
naloxone hydrochlorideNALOXONE HYDROCHLORIDEMedical Purchasing Solutions, LLCfa1ca55b-f56b-0d9b-e053-6294a90a258a2023-04-24Warnings, Adverse reactionsExact identifier
unii: F850569PQR
Naloxone HydrochlorideNALOXONE HYDROCHLORIDEMedical Purchasing Solutions, LLCea4ea2fe-af48-0b3c-e053-2a95a90a0ad52023-04-24Warnings, Adverse reactionsExact identifier
application number: ANDA072076
rxcui: 1191250
unii: F850569PQR
Naloxone HydrochlorideNALOXONE HYDROCHLORIDEMedical Purchasing Solutions, LLCf9c5efca-443a-41a0-e053-6294a90a87742023-04-20Warnings, Adverse reactionsExact identifier
rxcui: 1191250
unii: F850569PQR
NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDEHF Acquisition Co. LLC, DBA HealthFirst74fcd243-94b3-ec77-e053-2991aa0a229c2022-12-09Warnings, Adverse reactionsExact identifier
unii: F850569PQR
NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDEProficient Rx LP8d529b4c-85fd-4e50-9443-9080825307bf2022-10-01Warnings, Adverse reactionsExact identifier
unii: F850569PQR
NarcanNALOXONE HYDROCHLORIDEProficient Rx LP76b5a1ce-e601-457c-ab35-43533bba43942022-08-01Warnings, Adverse reactionsExact identifier
unii: F850569PQR
e4dd2392-293d-0deb-e053-2995a90abd3f4838e624-7b53-4e45-b42c-ef12135071882022-07-28Warnings, Adverse reactionsExact identifier
spl set id: 4838e624-7b53-4e45-b42c-ef1213507188
Naloxone Hydrochloride Injection, USP, Auto-InjectorNALOXONE HYDROCHLORIDEKaleo, Inc.b5463553-b775-47a3-8d10-31e01ca1ec722022-03-11Warnings, Adverse reactionsExact identifier
unii: F850569PQR
Naloxone HydrochlorideNALOXONE HYDROCHLORIDEInternational Medication Systems, Limitedd2f5bfa0-933e-46d0-8b1a-9f90e6aaba542021-12-13Warnings, Adverse reactionsExact identifier
application number: ANDA072076
ndc (package): 76329-3469-1
ndc (product): 76329-3469
ndc11 (package): 76329346901
rxcui: 1191250
spl id: 2ab20a74-a067-4d43-84fb-fe331192c34b
spl set id: d2f5bfa0-933e-46d0-8b1a-9f90e6aaba54
unii: F850569PQR
naloxone hydrochlorideNALOXONE HYDROCHLORIDEBaxter Healthcare Corporationd04ae2d7-01b9-405d-bb7a-bf2d876ce26a2021-07-02Warnings, Adverse reactionsExact identifier
unii: F850569PQR
Naloxone HydrochlorideNALOXONE HYDROCHLORIDEMylan Institutional LLCd96ebf2e-1051-4b5b-b1c6-2543dbbb2d042021-04-21Warnings, Adverse reactionsExact identifier
unii: F850569PQR
NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDEBaxter Healthcare Corporation3d8813be-6d22-46f1-ac25-0d8a817a521c2020-11-25Warnings, Adverse reactionsExact identifier
unii: F850569PQR
Naloxone HydrochlorideNALOXONE HYDROCHLORIDEMylan Institutional LLCf0932877-1f3b-4d5e-82d2-dd6c53db47302020-08-17Warnings, Adverse reactionsExact identifier
unii: F850569PQR
Naloxone HydrochlorideNALXONE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.8cc25cf1-008c-4808-baec-49f35a887fae2020-03-20Warnings, Adverse reactionsExact identifier
unii: F850569PQR

Reported adverse events (FAERS/openFDA)#

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