FDA.reportPublic FDA data

NDC 76329-3369-01 - 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
76329-3369
Requested NDC
76329-3369-01
Package NDCs from labels
76329-3369-1, 76329-3369-01
Manufacturer
Henry Schein, Inc
Effective date
2026-03-02
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
NALOXONE HYDROCHLORIDE - Henry Schein, IncHenry Schein, Inc2026-03-02HUMAN PRESCRIPTION DRUG LABEL
Naloxone Hydrochloride - REMEDYREPACK INC.REMEDYREPACK INC.2026-02-10HUMAN PRESCRIPTION DRUG LABEL
Naloxone Hydrochloride - International Medication Systems, LimitedInternational Medication Systems, Limited2024-12-16HUMAN PRESCRIPTION DRUG LABEL
NALOXONE HYDROCHLORIDE - HF Acquisition Co. LLC, DBA HealthFirstHF Acquisition Co. LLC, DBA HealthFirst2024-01-25HUMAN PRESCRIPTION DRUG LABEL
Naloxone Hydrochloride - Medical Purchasing Solutions, LLCMedical Purchasing Solutions, LLC2023-05-15HUMAN PRESCRIPTION DRUG LABEL
NALOXONE HYDROCHLORIDE INJECTION, USP Opioid Antagonist Rx OnlyGeneral Injectables & Vaccines, Inc.2022-12-28HUMAN PRESCRIPTION DRUG LABEL
Naloxone Hydrochloride - Cardinal HealthCardinal Health2019-09-16HUMAN PRESCRIPTION DRUG LABEL
Naloxone Hydrochloride - A-S Medication SolutionsA-S Medication Solutions2018-08-14HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76329-3369-1Naloxone Hydrochloride2 mL in 1 SYRINGEINJECTION27
76329-3369-1Naloxone Hydrochloride10 in 1 BOXINJECTION107

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76329-3369NALOXONE 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
76329-3369-1ML - Milliliter76329-3369d625d3e0-0ffe-4701-b3d8-177b7de5ef4c12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Naloxone HydrochlorideACTIVE INGREDIENTF850569PQRNALOXONE HYDROCHLORIDE INJECTION [CARDINAL HEALTH]5
NaloxoneACTIVE MOIETY36B82AMQ7NNALOXONE HYDROCHLORIDE INJECTION [CARDINAL HEALTH]5
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBNALOXONE HYDROCHLORIDE INJECTION [CARDINAL HEALTH]5
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XNALOXONE HYDROCHLORIDE INJECTION [CARDINAL HEALTH]5
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 3 of 50 · 988 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PEG 3350 and ElectrolytesPOLYETHYLENE GLYCOL 3350, SODIUM SULFATE ANHYDROUS, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDEA-S Medication Solutions19daf830-7270-4661-81b1-ded38f867f282026-07-24Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Whisidom Saline SolutionSODIUM CHLORIDE 0.9% SALINE SOLUTIONJiangxi Yudexi Pharmaceutical Co., LTD4e4e4169-2a14-3466-e063-6394a90a081b2026-07-20WarningsExact identifier
unii: 451W47IQ8X
SalineNASALBEST CHOICE (VALU MERCHANDISERS COMPANY)71485e82-bf54-4b8b-8dd2-2a07615345202026-07-17WarningsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDELABORATORIOS GRIFOLS SAeb811d79-fdb8-1f1a-c2ad-1cc4bfc7eadf2026-07-15Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
WHWSWB 0.9% SALINESODIUM CHLORIDEYiwu Huanshu E-commerce Co., Ltd5082b773-79b2-2501-e063-6394a90a170f2026-07-11WarningsExact identifier
unii: 451W47IQ8X
SALINE NASALSODIUM CHLORIDEALAINA HEALTHCARE PRIVATE LIMITEDed30a7f9-7132-42da-9bed-63a9b1c80ab22026-07-07WarningsExact identifier
unii: 451W47IQ8X
Naloxone HydrochlorideNALOXONE HYDROCHLORIDESportpharm LLC3750bf77-342c-4469-8bbb-f71009aa03fa2026-07-02WarningsExact identifier
unii: F850569PQR
The Cell Salt Co. Daily Blend 12 in 1CALC FLUOR, CALC PHOS, CALC SULPH, FERRUM PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT MUR, NAT PHOS, NAT SULPH, SILICEAThe Cell Salt Company LLC55826f59-acf4-7370-e063-6394a90afed72026-07-01WarningsExact identifier
unii: 451W47IQ8X
NebuClear MD SalineNEBUCLEAR MD SALINEBlue Echo Care LLC55820ff9-7b4b-2bce-e063-6394a90a8b432026-06-30WarningsExact identifier
unii: 451W47IQ8X
NebuClear MD SalineNEBUCLEAR MD SALINEBlue Echo Care LLC55806cb8-cf92-c4e5-e063-6394a90aaa2d2026-06-30WarningsExact identifier
unii: 451W47IQ8X
NebuClear MD SalineNEBUCLEAR MD SALINEBlue Echo Care LLC5581d8e5-4105-e9da-e063-6394a90a316e2026-06-30WarningsExact identifier
unii: 451W47IQ8X
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
MCAS SupportAPIS MELLIFICA, ANTIMONIUM CRUDUM, ASCORBICUM ACIDUM, BOVISTA, CARBOLICUM ACIDUM, CHAMOMILLA, CORTISONE ACETICUM, GINKGO BILOBA, HEPAR SUIS, HISTAMINUM HYDROCHLORICUM, NATRUM MURIATICUM, QUERCETIN, RHUS TOX, SCUTELLARIA LATERIFLORA, STOMACH (SUIS), URTICA URENSDeseret Biologicals, Inc.af3d5f8f-6f24-4045-8730-c776ff54bcc42026-06-24WarningsExact identifier
unii: 451W47IQ8X
Pentazocine and naloxonePENTAZOCINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEActavis Pharma, Inc.a28450a0-ac93-4235-b9a6-58cdf24773cb2026-06-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: F850569PQR
0.9% Sodium Chloride Saline SolutionSODIUM CHLORIDEYunqi Cosmetics (Shenzhen) Co., Ltd546af257-dbd1-11fc-e063-6394a90a8e0a2026-06-16WarningsExact identifier
unii: 451W47IQ8X
BM BM68 DROPSARGENTUM NIT, BARYTA CARB., DULCAMARA, GELSEMIUM, KALI BROM, NAT MUR, CAUSTICUMBM Private Limited53f9c99a-0f20-0358-e063-6394a90af4e02026-06-15WarningsExact identifier
unii: 451W47IQ8X
BM BM68ARGENTUM NIT, BARYTA CARB, DULCAMARA, GELSEMIUM, KALI BROM, NAT MUR, CAUSTICUMTotal Operations Management LLC DBA:Bestmade Natural Products Micro5448c76a-2ecb-9402-e063-6294a90a6ad72026-06-15WarningsExact identifier
unii: 451W47IQ8X
BM BIO28 ALCOHOLCALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEATotal Operations Management LLC DBA:Bestmade Natural Products Micro544b66c4-49df-556f-e063-6394a90af3ed2026-06-15WarningsExact identifier
unii: 451W47IQ8X
Male SupportAGNUS CASTUS, AURUM METALLICUM, BENZOICUM ACIDUM, BRYONIA (ALBA), BUFO RANA, CALADIUM SEGUINUM, CHIMAPHILA UMBELLATA, CLEMATIS ERECTA, CONIUM MACULATUM, CORTISONE ACETICUM, HYPOTHALAMUS SUIS, KALI ARSENICOSUM, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, PROSTATE (SUIS), RHODODENDRON CHRYSANTHUM, SABAL SERRULATA, SELENIUM METALLICUM, SEPIA, TESTOSTERONE, THUJA OCCIDENTALISDeseret Biologicals, Inc.29cefc89-3bb6-484e-84ab-116b5827a4c32026-06-15WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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