FDA.reportPublic FDA data

NDC 76329-3302-01 - Dextrose Monohydrate

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
76329-3302
Requested NDC
76329-3302-01
Package NDCs from labels
76329-3302-1, 76329-3302-01
Manufacturer
REMEDYREPACK INC.
Effective date
2025-09-26
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Dextrose Monohydrate - REMEDYREPACK INC.REMEDYREPACK INC.2025-09-26HUMAN PRESCRIPTION DRUG LABEL
Dextrose monohydrate - HF Acquisition Co LLC, DBA HealthFirstHF Acquisition Co LLC, DBA HealthFirst2024-02-22HUMAN PRESCRIPTION DRUG LABEL
Dextrose Monohydrate - International Medication Systems, LimitedInternational Medication Systems, Limited2022-12-20HUMAN PRESCRIPTION DRUG LABEL
Dextrose Monohydrate - Medical Purchasing Solutions, LLCMedical Purchasing Solutions, LLC2022-10-07HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76329-3302-1Dextrose Monohydrate1 in 1 CARTONINJECTION, SOLUTION15
76329-3302-1Dextrose Monohydrate50 mL in 1 SYRINGEINJECTION, SOLUTION505

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76329-3302DEXTROSE MONOHYDRATE (DEXTROSE MONOHYDRATE) INJECTION, SOLUTION [INTERNATIONAL MEDICATION SYSTEMS, LIMITED ]5Current NDC, Legacy NDC, 2 package rows20221221_fcc7ac79-cd70-4f03-a4de-f051f9ca1f7d.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76329-3302-1ML - Milliliter76329-330201b6d87f-f4d3-4ed0-85b9-6df166aed70612021-12-08

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 6 of 16 · 316 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sterile WaterWATERICU Medical Inc.e3484bc6-ed7f-43ef-9d49-c131a8dff2dd2025-11-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
DextroseDEXTROSEICU Medical Inc.b5cb7a5a-bbe8-4217-a82e-da818f7771c92025-11-02Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
Lactated Ringers and DextroseSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, AND DEXTROSE MONOHYDRATEICU Medical Inc.d310d170-5eeb-471b-af1a-0e845001d21d2025-11-02Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
DextroseDEXTROSE MONOHYDRATEICU Medical, Inc.cb578dba-094c-4787-951d-763d12fd06e12025-11-01Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
Potassium Chloride in Lactated Ringers and DextrosePOTASSIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, SODIUM LACTATE, AND DEXTROSE MONOHYDRATEICU Medical Inc.237b39fa-916e-4a54-99c8-4ae9ad54f0562025-10-30Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
Normosol-R and DextroseDEXTROSE, SODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDEICU Medical Inc.ead1fca3-eff4-478f-8a8f-67510f80151a2025-10-30Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
Potassium Chloride in DextroseDEXTROSE MONOHYDRATE AND POTASSIUM CHLORIDE INJECTION, SOLUTIONICU Medical Inc.02d694b5-3600-4d55-bd5c-924abaec53152025-10-30Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
Ionosol MB and DextroseDEXTROSE MONOHYDRATE, SODIUM LACTATE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, POTASSIUM PHOSPHATE, MONOBASIC, AND SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEICU Medical Inc.1b457b1d-0e80-4578-ba6f-dedf513fc9622025-10-30Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
Sterile WaterWATERICU Medical Inc.1c0bbcb7-5ed6-4ee7-b297-080d3359474e2025-10-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Potassium Chloride in Lactated Ringers and DextroseDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDEBaxter Healthcare Corporation05f326e6-10e4-4ceb-8a23-f53c592f00b82025-10-29Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
Lactated Ringers and DextroseSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE AND DEXTROSE MONOHYDRATEBaxter Healthcare Corporation6acc9f96-7088-45a7-b48f-1a861e3467ab2025-10-29Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
Bacteriostatic WaterWATERHenry Schein, Inc.a833502e-a622-4e81-8c58-cef6ccb6c4c92025-10-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
NORMOSOL-M AND DEXTROSEDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, POTASSIUM ACETATE, AND MAGNESIUM ACETATEICU Medical Inc.aba60c84-94d9-46d0-bdbb-25e0c4e8cc412025-10-24Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
Sterile WaterWATERBecton Dickinson and Companycab03cda-4660-4020-a3be-bf86242ff6642025-10-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
DextroseDEXTROSE MONOHYDRATEICU Medical Inc.cdf35d11-fbc8-4f8e-85a8-33220312c0b42025-10-17Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
40946d0e-f46a-9c25-e063-6394a90a07c6603a6784-4acc-4d75-9e1f-acf2298c78922025-10-07Warnings, Adverse reactionsExact identifier
spl set id: 603a6784-4acc-4d75-9e1f-acf2298c7892
Xpect EyewashEYEWASHCintas Corporation1d69365d-662b-4248-8fa9-1629451b549a2025-09-30WarningsExact identifier
unii: 059QF0KO0R
CheBoho TEA TREE ACNECHEBOHO TEA TREE ACNEOpalshi(Guangzhou)E-commerce Co. Ltd.3fc4cf84-b2da-c593-e063-6394a90abc5c2025-09-27WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERProPharma Distribution3f2ae880-852f-b45d-e063-6394a90aa1cc2025-09-19Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
DextroseDEXTROSE MONOHYDRATEProPharma Distribution3eff8bcd-6a33-428f-e063-6394a90afa682025-09-17Warnings, Adverse reactionsExact identifier
unii: LX22YL083G

Reported adverse events (FAERS/openFDA)#

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