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 2 of 6 · 101 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Naloxone HydrochlorideNALOXONE HYDROCHLORIDEREMEDYREPACK INC.68df290c-d776-4cfc-9565-332eb56c47232026-02-10Warnings, Adverse reactionsExact identifier
application number: ANDA072076
rxcui: 1191250
unii: F850569PQR
naloxone hydrochlorideNALOXONE HYDROCHLORIDELifestar Pharma LLCaef6719c-cd71-46ee-b7b1-1806b939bf3e2026-02-09Warnings, Adverse reactionsExact identifier
unii: F850569PQR
Buprenorphine and NaloxoneBUPRENORPHINE AND NALOXONECamber Pharmaceuticals, Inc.221195e4-de08-414c-af08-a611a74789de2026-01-30Warnings, Adverse reactionsExact identifier
unii: F850569PQR
Naloxone HydrochlorideNALOXONE HYDROCHLORIDEAvKARE1766a7f1-d301-945f-e063-6294a90ac6f42026-01-14WarningsExact identifier
unii: F850569PQR
RiViveNALOXONE HYDROCHLORIDEHarm Reduction Therapeutics, Inc.1c4f1b9d-1c70-4666-a90e-2f5d2c670d4d2026-01-13WarningsExact identifier
unii: F850569PQR
Naloxone HydrochlorideNALOXONE HYDROCHLORIDESina Health Inc2879294f-9af9-459e-e063-6394a90a08202026-01-12Warnings, Adverse reactionsExact identifier
unii: F850569PQR
NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDEPadagis Israel Pharmaceuticals Ltdb5d40220-f194-4835-b70c-f304ecb222d52026-01-06WarningsExact identifier
unii: F850569PQR
Naloxone HydrochlorideNALOXONE HYDROCHLORIDEDr. Reddy's Laboratories, Inc.b1303f15-c48b-a44d-b28a-72f370094e022026-01-01Warnings, Adverse reactionsExact identifier
rxcui: 1191250
unii: F850569PQR
ZubsolvBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEOrexo US, Inc.5f5cfcfe-d52b-49e6-8fe4-550477332dd22025-12-27Warnings, Adverse reactionsExact identifier
unii: F850569PQR
Naloxone HydrochlorideNALOXONE HYDROCHLORIDEBPI Labs LLC5de44ee7-6525-4857-9a67-8882e96dbeb52025-12-26Warnings, Adverse reactionsExact identifier
rxcui: 1191250
unii: F850569PQR
SuboxoneBUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDEINDIVIOR INC.8a5edcf9-828c-4f97-b671-268ab13a8ecd2025-12-22Warnings, Adverse reactionsExact identifier
unii: F850569PQR
NarcanNALOXONE HYDROCHLORIDEEmergent Devices Inc.724df050-5332-4d0a-9a5f-17bf08a547e12025-12-05Warnings, Adverse reactionsExact identifier
unii: F850569PQR
ZIMHINALOXONE HYDROCHLORIDEZMI Pharma Inc.523c0909-bff6-4010-988a-53de18b7cb3f2025-12-04Warnings, Adverse reactionsExact identifier
unii: F850569PQR
NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDEStrategic Sourcing Services LLC577fbd57-7054-4536-86c1-d43bc99cc7b12025-11-19WarningsExact identifier
unii: F850569PQR
NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDEHenry Schein, Inc.ddeebc32-9aab-4a2f-8c87-74335d17d5ef2025-10-28Warnings, Adverse reactionsExact identifier
unii: F850569PQR
Naloxone HydrochlorideNALOXONE HYDROCHLORIDEProPharma Distribution3f2bb95a-aeca-c0b7-e063-6394a90a627b2025-09-19Warnings, Adverse reactionsExact identifier
unii: F850569PQR
Naloxone HydrochlorideNALOXONE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.e6467385-6990-498c-8a0e-f4a40ef33cb72025-09-02Warnings, Adverse reactionsExact identifier
rxcui: 1191250
unii: F850569PQR
NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDEAMERISOURCE BERGENcce38c13-0d2f-49bb-94fa-6f2bbb4d59842025-08-31WarningsExact identifier
unii: F850569PQR
PENTAZOCINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEPENTAZOCINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDELupin Pharmaceuticals,Inc.017ef042-40aa-44c9-baa8-037f063568452025-08-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: F850569PQR
KLOXXADONALOXONE HCLHikma Specialty USA Inc.ebf0f833-c1c0-487c-8f29-01fa8c61b6cb2025-08-25Warnings, Adverse reactionsExact identifier
unii: F850569PQR

Reported adverse events (FAERS/openFDA)#

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