FDA.reportPublic FDA data

NDC 0409-6648-16 - 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
0409-6648
Requested NDC
0409-6648-16
Package NDCs from labels
0409-6648-16, 0409-6648-02
Manufacturer
ProPharma Distribution
Effective date
2026-10-14
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Dextrose - ProPharma DistributionProPharma Distribution2026-10-14HUMAN PRESCRIPTION DRUG LABEL
Dextrose - Hospira, Inc.Hospira, Inc.2026-07-13HUMAN PRESCRIPTION DRUG LABEL
50% DextroseHenry Schein, Inc.2026-04-09HUMAN PRESCRIPTION DRUG LABEL
DEXTROSE - HF Acquisition Co LLC, DBA HealthFirstHF Acquisition Co LLC, DBA HealthFirst2024-02-19HUMAN PRESCRIPTION DRUG LABEL
Dextrose - Medical Purchasing Solutions, LLC | Medical Purchasin Solutions, LLCMedical Purchasing Solutions, LLC | Medical Purchasin Solutions, LLC2023-05-30HUMAN PRESCRIPTION DRUG LABEL
Dextrose - General Injectables & Vaccines, IncGeneral Injectables & Vaccines, Inc2022-12-19HUMAN PRESCRIPTION DRUG LABEL
Model AA-8565CV-ACT Model AA-8565CV - Aerospace Accessory Service, IncAerospace Accessory Service, Inc2021-05-18MEDICAL DEVICE
Sodium Chloride - Aerospace Accessory Service, IncAerospace Accessory Service, Inc2021-05-18MEDICAL DEVICE
Dextrose - Physicians Total Care, Inc.Physicians Total Care, Inc.2011-01-13HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2021-09-27These highlights do not include all the information needed to use DEXTROSE INJECTION (50%) safely and effectively. See full prescribing information for DEXTROSE INJECTION (50%). DEXTROSE injection, for intravenous use Initial U.S. Approval: 1940
2021-09-27These highlights do not include all the information needed to use DEXTROSE INJECTION (50%) safely and effectively. See full prescribing information for DEXTROSE INJECTION (50%). DEXTROSE injection, for intravenous use Initial U.S. Approval: 1940
2021-09-27These highlights do not include all the information needed to use DEXTROSE INJECTION (50%) safely and effectively. See full prescribing information for DEXTROSE INJECTION (50%). DEXTROSE injection, for intravenous use Initial U.S. Approval: 1940
2021-09-27These highlights do not include all the information needed to use DEXTROSE INJECTION (50%) safely and effectively. See full prescribing information for DEXTROSE INJECTION (50%). DEXTROSE injection, for intravenous use Initial U.S. Approval: 1940
2021-09-27These highlights do not include all the information needed to use DEXTROSE INJECTION (50%) safely and effectively. See full prescribing information for DEXTROSE INJECTION (50%). DEXTROSE injection, for intravenous use Initial U.S. Approval: 1940
2021-07-23These highlights do not include all the information needed to use DEXTROSE INJECTION (50%) safely and effectively. See full prescribing information for DEXTROSE INJECTION (50%). DEXTROSE injection, for intravenous use Initial U.S. Approval: 1940
2021-07-23These highlights do not include all the information needed to use DEXTROSE INJECTION (50%) safely and effectively. See full prescribing information for DEXTROSE INJECTION (50%). DEXTROSE injection, for intravenous use Initial U.S. Approval: 1940
2021-07-23These highlights do not include all the information needed to use DEXTROSE INJECTION (50%) safely and effectively. See full prescribing information for DEXTROSE INJECTION (50%). DEXTROSE injection, for intravenous use Initial U.S. Approval: 1940
2021-07-23These highlights do not include all the information needed to use DEXTROSE INJECTION (50%) safely and effectively. See full prescribing information for DEXTROSE INJECTION (50%). DEXTROSE injection, for intravenous use Initial U.S. Approval: 1940
2021-07-23These highlights do not include all the information needed to use DEXTROSE INJECTION (50%) safely and effectively. See full prescribing information for DEXTROSE INJECTION (50%). DEXTROSE injection, for intravenous use Initial U.S. Approval: 1940

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0409-6648-02Dextrose25 in 1 TRAYINJECTION, SOLUTION2532
0409-6648-16Dextrose50 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION5032

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-6648DEXTROSE (DEXTROSE MONOHYDRATE) INJECTION, SOLUTION [HOSPIRA, INC.]28Current NDC, Legacy NDC, 2 package rows20250417_4ed365da-4e62-4329-c1b9-c197ab4fb6e1.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-6648-02ML - Milliliter0409-6648aac49f4b-c9aa-43d0-8957-40a1d61454bb12012-07-24
0409-6648-16ML - Milliliter0409-6648ad98732f-79fa-482d-ac62-532dba89582412021-08-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROSE MONOHYDRATEACTIVE INGREDIENTLX22YL083GDEXTROSE (DEXTROSE MONOHYDRATE) INJECTION, SOLUTION [HOSPIRA, INC.]13
ANHYDROUS DEXTROSEACTIVE MOIETY5SL0G7R0OKDEXTROSE (DEXTROSE MONOHYDRATE) INJECTION, SOLUTION [HOSPIRA, INC.]13
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBDEXTROSE (DEXTROSE MONOHYDRATE) INJECTION, SOLUTION [HOSPIRA, INC.]13
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IDEXTROSE (DEXTROSE MONOHYDRATE) INJECTION, SOLUTION [HOSPIRA, INC.]13
WATERINACTIVE INGREDIENT059QF0KO0RDEXTROSE (DEXTROSE MONOHYDRATE) INJECTION, SOLUTION [HOSPIRA, INC.]13
Dextrose MonohydrateACTIVE INGREDIENTLX22YL083GDEXTROSE (DEXTROSE MONOHYDRATE) INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC]3
DextroseACTIVE MOIETYIY9XDZ35W2DEXTROSE (DEXTROSE MONOHYDRATE) INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC]3
DEXTROSE MONOHYDRATEACTIVE INGREDIENTLX22YL083GDEXTROSE INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]1
DEXTROSEACTIVE MOIETYIY9XDZ35W2DEXTROSE INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBDEXTROSE INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IDEXTROSE INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RDEXTROSE INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, 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 2 of 763 · 15,259 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Alcohol Free Foaming Hand SanitizerBENZALKONIUM CHLORIDEBetco Corporation, Ltd.7e038b0a-4813-4f4b-ad66-0584d75a064f2026-09-09WarningsExact identifier
unii: F5UM2KM3W7
Burn CreamBENZALKONIUM CHLORIDE, LIDOCAINE HCITrifecta Pharmaceuticals USA LLCe9a9fc7c-31da-ea3f-e053-2a95a90a0eab2026-09-09WarningsExact identifier
application number: M003
unii: F5UM2KM3W7
unii: V13007Z41A
Ultra Blue Antibacterial Foaming Skin CleanserBENZALKONIUM CHLORIDEBetco Corporation, Ltdaa8f5b05-882d-d05a-e053-2995a90abaea2026-09-09WarningsExact identifier
unii: F5UM2KM3W7
Burn GelLIDOCAINE HCITrifecta Pharmaceuticals USA LLCe9d3e9be-1036-fad0-e053-2a95a90a6efe2026-09-09WarningsExact identifier
unii: V13007Z41A
Touchland Glow Mist Hand Sanitizer RosewaterALCOHOLChurch & Dwight Co., Inc.5a850866-bc5d-e595-e063-6394a90a335f2026-09-09WarningsExact identifier
unii: 3K9958V90M
Leader Artificial Tears 15 mLPOLYVINYL ALCOHOL, POVIDONECardinal Health8cccc589-3a8e-baad-e053-2a95a90ab8c72026-09-09WarningsExact identifier
unii: FZ989GH94E
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEDIRECT RXbae9c9c1-107f-0fcb-e053-2a95a90a75b22026-09-09Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
nitroglycerinNITROGLYCERINMedical Purchasing Solutions, LLC.5b150cd2-fac8-86ce-e063-6294a90a67b92026-09-09Warnings, Adverse reactionsExact identifier
rxcui: 198039
unii: G59M7S0WS3
Low Dose AspirinASPIRINStrategic Sourcing Services LLC7ce4807e-7bd5-41f1-a9c7-1f3af6acdc092026-09-09WarningsExact identifier
unii: R16CO5Y76E
SalineNASALRaritan Pharmaceuiticals Inc4b178e4e-a10f-4b75-8140-1f7548e203ad2026-09-09WarningsExact identifier
unii: 451W47IQ8X
severe cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDERite Aid Corporation4b8ae971-ab57-4937-a878-72d905d7b8492026-09-09WarningsExact identifier
unii: 362O9ITL9D
Cold and Flu ReliefACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLCARDINAL HEALTH 110, LLC. DBA LEADER 7000082ba9a73-60ef-49fd-960f-5ca2bb79555e2026-09-09WarningsExact identifier
unii: 362O9ITL9D
DextroseDEXTROSE MONOHYDRATEHenry Schein, Inc.8cf6943f-16e8-4521-863c-09bb0b55e2a92026-09-09Warnings, Adverse reactionsExact identifier
application number: NDA019445
rxcui: 727517
unii: LX22YL083G
DRx Choice maximum strength Severe Cough plus sore throatACETAMINOPHEN, DEXTROMETHORPHAN HBRRARITAN PHARMACEUTICALSa096cb76-0d1c-4ca8-854a-5199da0bc8f72026-09-09WarningsExact identifier
unii: 362O9ITL9D
Acetaminophen Extra StrengthACETAMINOPHENWal-Mart Stores Inc78874258-16cc-40b5-9e15-5943eddfce942026-09-08WarningsExact identifier
unii: 362O9ITL9D
SORE THROATPHENOLRaritan Pharmaceuticals Inc43ce374a-824c-4034-bf04-c351b4d8015b2026-09-08WarningsExact identifier
unii: 339NCG44TV
Alcohol Prep Pad MediumALCOHOL PREP PADYangzhou Huanrui Medical Technology Co., Ltd5af3eedc-d01e-c9e9-e063-6394a90a49e12026-09-08WarningsExact identifier
application number: M003
rxcui: 797544
unii: ND2M416302
RectivNITROGLYCERINAllergan, Inc.603aa9ed-54c4-4a35-ade4-690fa44850e42026-09-08Warnings, Adverse reactionsExact identifier
unii: G59M7S0WS3
VerifineALCOHOL SWABSPromisemed Hangzhou Meditech Co., LTD5af9f31b-0c92-e3a9-e063-6394a90a38c92026-09-08WarningsExact identifier
application number: M003
rxcui: 797544
unii: ND2M416302
Vicks DayQuil VapoCOOL SEVERE COLD and FLU plus CONGESTIONACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEThe Procter & Gamble Manufacturing Companyefb69cc1-a745-6efc-e053-2a95a90abdc92026-09-08WarningsExact identifier
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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