FDA.reportPublic FDA data

NDC 76329-1469-01 - 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
76329-1469
Requested NDC
76329-1469-01
Package NDCs from labels
76329-1469-1, 76329-1469-01
Manufacturer
International Medication Systems, Limited
Effective date
2024-12-16
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Naloxone Hydrochloride - International Medication Systems, LimitedInternational Medication Systems, Limited2024-12-16HUMAN PRESCRIPTION DRUG LABEL
Naloxone Hydrochloride Injection, USP Opioid Antagonist Rx OnlyHenry Schein, Inc.2024-11-04HUMAN PRESCRIPTION DRUG LABEL
Naloxone Hydrochloride - Medical Purchasing Solutions, LLCMedical Purchasing Solutions, LLC2023-04-24HUMAN PRESCRIPTION DRUG LABEL
NALOXONE HYDROCHLORIDE - General Injectables & Vaccines, IncGeneral Injectables & Vaccines, Inc2022-12-29HUMAN PRESCRIPTION DRUG LABEL
LifEMS NALOXONE - Lifsa Drugs LLCLifsa Drugs LLC2022-02-07HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76329-1469-1Naloxone Hydrochloride2 mL in 1 SYRINGEINJECTION27
76329-1469-1Naloxone Hydrochloride10 in 1 BOXINJECTION107

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76329-1469NALOXONE HYDROCHLORIDE INJECTION [INTERNATIONAL MEDICATION SYSTEMS, LIMITED ]7Current NDC, Legacy NDC, 2 package rows20241222_236349ef-2cb5-47ca-a3a5-99534c3a4996.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76329-1469-1ML - Milliliter76329-1469ce0501de-2c9e-4e9d-9c53-c09f1e91821212015-06-09
76329-1469-5ML - Milliliter76329-1469f568fbe3-a663-47fb-8697-ddc2156dc18a12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Naloxone HydrochlorideACTIVE INGREDIENTF850569PQRNALOXONE HYDROCHLORIDE INJECTION [INTERNATIONAL MEDICATION SYSTEMS, LIMITED ]3
NaloxoneACTIVE MOIETY36B82AMQ7NNALOXONE HYDROCHLORIDE INJECTION [INTERNATIONAL MEDICATION SYSTEMS, LIMITED ]3
NALOXONE HYDROCHLORIDEACTIVE INGREDIENTF850569PQRNALOXONE HYDROCHLORIDE INJECTION [GENERAL INJECTABLES & VACCINES, INC]1
NALOXONEACTIVE MOIETY36B82AMQ7NNALOXONE HYDROCHLORIDE INJECTION [GENERAL INJECTABLES & VACCINES, INC]1

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 4 of 140 · 2,792 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Smart Care Hand Sanitizer,2pk with Woven Lanyard and Charms - Sparkling Watermelon/ Pomegranate RaspberryALCOHOLShenzhen Lantern Scicence Co.,Ltd.5a2a89f4-838e-e3ea-e063-6294a90a1ac22026-08-27WarningsExact identifier
application number: M003
Biopure Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.59ed87d5-dab1-abab-e063-6394a90a024d2026-08-26WarningsExact identifier
application number: M003
KUGIG ALOE FOAMING INTIMATE WASHINTIMATE CLEANSING FOAMHong Kong KangXing Centennial Management Limited59f4d398-1186-a168-e063-6294a90ab44b2026-08-26WarningsExact identifier
unii: 059QF0KO0R
Stone Hand SanitizerISOPROPYL ALCOHOLhandetizer, LLC.59f821e0-b129-5c39-e063-6294a90a47a02026-08-26WarningsExact identifier
unii: ND2M416302
Povidone Iodine SwabstickPOVIDONE IODINE 10%Trifecta Pharmaceuticals USA LLC59f82f9d-8c39-6890-e063-6294a90a090e2026-08-26WarningsExact identifier
application number: M003
Gentian VioletGENTIAN VIOLETVitamex USA, Corp21742061-fc0b-f750-e063-6394a90a75082026-08-26WarningsExact identifier
application number: M003
MercurochromeBENZALKONIUM CHLORIDEVitamex USA, Corp21652b11-715d-0c54-e063-6294a90a88552026-08-26WarningsExact identifier
application number: M003
Scentsational Square Hand SanitizerHAND SANITIZERRaining Rose, Inc.59f9bacf-80dc-3468-e063-6294a90a0ae12026-08-26WarningsExact identifier
application number: M003
Biopure Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.59fa27b4-dfd4-720b-e063-6394a90af6592026-08-26WarningsExact identifier
application number: M003
Biopure Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.59fb22d6-f6a4-42cd-e063-6394a90a859a2026-08-26WarningsExact identifier
application number: M003
Biopure Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.59fbb054-461e-aa6e-e063-6394a90a470c2026-08-26WarningsExact identifier
application number: M003
Naloxone HydrochlorideNALOXONE HYDROCHLORIDEAmneal Pharmaceuticals LLC8091a73d-9ecd-4578-a57b-5d85a2c5a16a2026-08-25WarningsExact identifier
unii: F850569PQR
Curad Alcohol Sterile, ThickISOPROPYL ALCOHOLMedline Industries, LPb769898e-a73f-4323-af15-bee8dbe455b62026-08-25WarningsExact identifier
application number: M003
rxcui: 797544
unii: ND2M416302
Hydrogen PeroxideHYDROGEN PEROXIDEYour Military Exchangesa71734c6-6b92-4d3d-84d1-a07f592fa8282026-08-25Warnings, Adverse reactionsExact identifier
application number: M003
Biopure Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.59e742a6-61f9-59f7-e063-6394a90a87382026-08-25WarningsExact identifier
application number: M003
Biopure Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.59e7dfb1-49b5-d2be-e063-6394a90a04d82026-08-25WarningsExact identifier
application number: M003
Sterile WaterWATERREMEDYREPACK INC.5dd5d148-6e23-41de-bff5-551b2aea95982026-08-24Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Biopure Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.59d3c369-86aa-8ebd-e063-6394a90aa8062026-08-24WarningsExact identifier
application number: M003
Biopure Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.59d7fc3c-3a93-153d-e063-6394a90ac6472026-08-24WarningsExact identifier
application number: M003
Be Smart Get Prepared Hand SanitizerALCOHOLTotal Resources International, Inc23d0dc62-28d6-4d1f-a7d5-4b14f5c9fb1e2026-08-24WarningsExact identifier
application number: M003

Reported adverse events (FAERS/openFDA)#

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