FDA.reportPublic FDA data

NDC 65219-458-05 - Dextrose

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
65219-458
Requested NDC
65219-458-05
Package NDCs from labels
65219-458-05, 65219-458-30
Manufacturer
FRESENIUS KABI USA, LLC
Effective date
2024-08-22
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Dextrose - FRESENIUS KABI USA, LLCFRESENIUS KABI USA, LLC2024-08-22HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65219-458-05Dextrose250 mL in 1 BAGINJECTION, SOLUTION2501
65219-458-30Dextrose30 in 1 CASEINJECTION, SOLUTION301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65219-458DEXTROSE (DEXTROSE MONOHYDRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1Current NDC, 2 package rows20240828_576a22d8-5f2f-497e-80ad-1842ca74bb53.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65219-458-05ML - Milliliter65219-458a5e89866-7f57-45e1-b7fa-b27620c4f55412024-11-05
65219-458-30ML - Milliliter65219-4583a50a23e-e844-4e94-89bd-5a346e67cd2912024-11-05

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 7 · 124 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DextroseDEXTROSE MONOHYDRATEHenry Schein, Inc.40fd1ac4-39bb-45fb-ba99-4fb65481f2312026-04-09Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
DextroseDEXTROSE MONOHYDRATEBecton Dickinson and Company8e7046f8-841e-465a-af69-af9fb3d6799d2026-03-17Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
DEXTROSEDEXTROSEHF Acquisition Co. LLC. DBA HealthFirst4d2d3d3d-d96e-4005-e063-6394a90afd9a2026-03-16Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
DextroseDEXTROSE MONOHYDRATEFresenius Kabi USA, LLC3b8f2692-4371-4f1a-95af-b41842131fdd2026-03-13Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
Additive Formula 3DEXTROSE MONOHYDRATE, TRISODIUM CITRATE DIHYDRATE, SODIUM CHLORIDE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, CITRIC ACID MONOHYDRATE, AND ADENINETerumo BCT, Ltd9a5247a1-cc05-442d-b2d0-950f887f03c22026-01-30Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
Lidocaine Hydrochloride and DextroseLIDOCAINE HYDROCHLORIDE ANHYDROUS AND DEXTROSE MONOHYDRATEProPharma Distribution48c0ee87-f722-1a71-e063-6394a90a72d12026-01-19Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
Lidocaine Hydrochloride and DextroseLIDOCAINE HYDROCHLORIDE ANHYDROUS AND DEXTROSE MONOHYDRATEB. Braun Medical Inc.7dff29d9-522d-40eb-a9d9-42377912d6402026-01-14Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
DextroseDEXTROSE MONOHYDRATEBECTON DICKINSON AND COMPANY32132016-1870-481b-9816-e11beb03ca0b2026-01-08Warnings, Adverse reactionsExact identifier
application number: ANDA207449
rxcui: 1795616
rxcui: 1795609
rxcui: 1795610
unii: LX22YL083G
Sterile Cord Blood Collection Unit (MSC128D)ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE SOLUTIONMaco Productions251fd4cb-4aa4-4473-9f89-968da856eb772025-12-18WarningsExact identifier
unii: LX22YL083G
Sterile Cord Blood Collection Unit (MSC127D)ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE SOLUTIONMaco Productions75a008b2-9666-4bfa-ab18-6d09b43b22152025-12-18WarningsExact identifier
unii: LX22YL083G
Pall Sterile Cord Blood Collection UnitSTERILE CORD BLOOD COLLECTION UNITGlobal Life Sciences Solutions USA LLCaa9340b7-cc63-e17d-e053-2a95a90ad4d92025-12-18WarningsExact identifier
unii: LX22YL083G
DextroseDEXTROSE MONOHYDRATEFresenius Kabi USA, LLCbd250a46-d229-4e80-b5a1-b34169ccecc42025-12-17Warnings, Adverse reactionsExact identifier
application number: ANDA207449
rxcui: 1795616
rxcui: 1795607
rxcui: 1795609
rxcui: 1795610
unii: LX22YL083G
STERILE CORD BLOOD COLLECTION UNIT (MSC123D)ANTICOAGULANT CITRATE PHOSPHATE DEXTROSEMaco Productionse3b456ec-4578-485f-a696-8a343505f30b2025-12-16WarningsExact identifier
unii: LX22YL083G
ACD-AANTICOAGULANT CITRATE DEXTROSE SOLUTION FORMULA AFenwal, Inc.ab19b011-0a51-4f04-9881-d9fc7cae95ae2025-11-25Exact identifier
unii: LX22YL083G
Dextrose in Lactated RingersDEXTROSE, SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDEB. Braun Medical Inc.190da07e-a616-46e6-b4e5-1c0ba39306e52025-11-05Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
DextroseDEXTROSE MONOHYDRATEICU Medical, Inc.8b25b7e0-703e-4b43-a4eb-52863511602d2025-11-02Warnings, Adverse reactionsExact identifier
rxcui: 1795616
rxcui: 1795607
rxcui: 1795612
rxcui: 1795609
rxcui: 1795610
unii: LX22YL083G
Potassium Chloride in Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, AND POTASSIUM CHLORIDEICU Medical Inc.d8ee14e9-6733-4813-9f21-2b043a5f71882025-11-02Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE AND SODIUM CHLORIDEICU Medical Inc.4555b1bf-6d97-4798-a63d-6d34291c85ce2025-11-02Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
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

Reported adverse events (FAERS/openFDA)#

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