FDA.reportPublic FDA data

Dextrose 50% Solution

Manufacturer
Nova-Tech, Inc.
Effective date
2020-03-13
Label type
OTC ANIMAL DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:40:43

Label at a glance#

ProductDextrose 50% Solution
Active ingredientDEXTROSE MONOHYDRATE
Label structure9 sections

Dosage and administration

The usual dose is 50 mL per 100 lbs of body weight. It should be administered intravenously only. Dosage may be repeated in 8 to 10 hours or on successive days if necessary.

Storage and handling

Store between 15°C-30°C (59°F-86°F).

Label contents#

Full prescribing information#

Dosage And Administration:

DOSAGE & ADMINISTRATION SECTION

The usual dose is 50 mL per 100 lbs of body weight. It should be administered intravenously only. Dosage may be repeated in 8 to 10 hours or on successive days if necessary.

Caution:

PRECAUTIONS SECTION

It should be warmed to body temperature and administered slowly. This product contains no presevatives. Do not use if solution is not clear. Entire contents should be used upon opening. Discard any unused portion.

GENERAL PRECAUTIONS SECTION

FOR ANIMAL USE ONLY
KEEP OUT OF REACH OF CHILDREN

Active Ingredients

DOSAGE FORMS & STRENGTHS SECTION

Dextrose H2O...........................50% w/v

Water for Injection...................q.s.

Indications:

INDICATIONS & USAGE SECTION

Dextrose 50% Solution is indicated for use as an aid in the treatment of uncomplicated primary ketosis in cattle.

STORAGE AND HANDLING SECTION

Store between 15°C-30°C (59°F-86°F).

GENERAL PRECAUTIONS SECTION

TAKE TIME OBSERVE LABEL DIRECTIONS

INFORMATION FOR OWNERS/CAREGIVERS SECTION

Manufactured by:

Nova-Tech, Inc.

Grand Island, NE 68801 USA

18-801

RMS 92-325

NDC# 65207-801-50

Nova-Tech® Animal Health

Dextrose 50% Solution

Sterile Solution

Net Contents:

500 mL (16.91 fl oz)

Assembled in USA

Lot No.               Exp. Date

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Container labelContainer labelContainer labelContainer label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
237653dextrose 50 % Injectable SolutionPSN1
237653glucose 500 MG/ML Injectable SolutionSCD1
237653dextrose 50 % Injectable SolutionSY1
237653dextrose 500 MG/ML Injectable SolutionSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65207-801-50Dextrose 50% Solution500 mL in 1 BOTTLE, PLASTICINJECTION, SOLUTION5001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65207-801DEXTROSE 50% SOLUTION (DEXTROSE) INJECTION, SOLUTION [NOVA-TECH, INC.]11 package rows20200314_87a898da-efed-4618-8d34-f0fa452979a0.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
65207-80165207-801-50

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
NameUNIIKind
DEXTROSE MONOHYDRATELX22YL083GACTIB

Source Document#

Source XML · Source PDF

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 1 of 2 · 33 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DextroseDEXTROSE MONOHYDRATEHenry Schein, Inc.8cf6943f-16e8-4521-863c-09bb0b55e2a92026-09-09Warnings, Adverse reactionsName fallback
generic name: DEXTROSE MONOHYDRATE
DextroseDEXTROSE MONOHYDRATEREMEDYREPACK INC.b8b77421-d687-45aa-82f6-d49bce644c102026-08-31Warnings, Adverse reactionsName fallback
generic name: DEXTROSE MONOHYDRATE
DextroseDEXTROSE MONOHYDRATEHospira, Inc.4ed365da-4e62-4329-c1b9-c197ab4fb6e12026-07-13Warnings, Adverse reactionsName fallback
generic name: DEXTROSE MONOHYDRATE
DextroseDEXTROSE MONOHYDRATEHospira, Inc.672264e3-9709-4bba-2a9d-12bf70c7396a2026-06-24Warnings, Adverse reactionsName fallback
generic name: DEXTROSE MONOHYDRATE
DEXTROSEDEXTROSE MONOHYDRATEBaxter Healthcare Corporation3bb406a9-f5cb-403a-b1bb-5c4facbea3d52026-06-11Warnings, Adverse reactionsName fallback
generic name: DEXTROSE MONOHYDRATE
DextroseDEXTROSE MONOHYDRATEHospira, Inc.10e98cb0-31a5-4ad1-3eaa-aa4af387a42d2026-06-02Warnings, Adverse reactionsName fallback
generic name: DEXTROSE MONOHYDRATE
DextroseDEXTROSE MONOHYDRATEHenry Schein, Inc.40fd1ac4-39bb-45fb-ba99-4fb65481f2312026-04-09Warnings, Adverse reactionsName fallback
generic name: DEXTROSE MONOHYDRATE
DextroseDEXTROSE MONOHYDRATEBecton Dickinson and Company8e7046f8-841e-465a-af69-af9fb3d6799d2026-03-17Warnings, Adverse reactionsName fallback
generic name: DEXTROSE MONOHYDRATE
DextroseDEXTROSE MONOHYDRATEFresenius Kabi USA, LLC3b8f2692-4371-4f1a-95af-b41842131fdd2026-03-13Warnings, Adverse reactionsName fallback
generic name: DEXTROSE MONOHYDRATE
DextroseDEXTROSE MONOHYDRATEBECTON DICKINSON AND COMPANY32132016-1870-481b-9816-e11beb03ca0b2026-01-08Warnings, Adverse reactionsName fallback
generic name: DEXTROSE MONOHYDRATE
DextroseDEXTROSE MONOHYDRATEFresenius Kabi USA, LLCbd250a46-d229-4e80-b5a1-b34169ccecc42025-12-17Warnings, Adverse reactionsName fallback
generic name: DEXTROSE MONOHYDRATE
DextroseDEXTROSE MONOHYDRATEICU Medical, Inc.8b25b7e0-703e-4b43-a4eb-52863511602d2025-11-02Warnings, Adverse reactionsName fallback
generic name: DEXTROSE MONOHYDRATE
DextroseDEXTROSE MONOHYDRATEICU Medical, Inc.cb578dba-094c-4787-951d-763d12fd06e12025-11-01Warnings, Adverse reactionsName fallback
generic name: DEXTROSE MONOHYDRATE
DextroseDEXTROSE MONOHYDRATEICU Medical Inc.cdf35d11-fbc8-4f8e-85a8-33220312c0b42025-10-17Warnings, Adverse reactionsName fallback
generic name: DEXTROSE MONOHYDRATE
DextroseDEXTROSE MONOHYDRATEProPharma Distribution3eff8bcd-6a33-428f-e063-6394a90afa682025-09-17Warnings, Adverse reactionsName fallback
generic name: DEXTROSE MONOHYDRATE
DextroseDEXTROSE MONOHYDRATEBaxter Healthcare Companybfc4224a-2fc9-4137-b4c6-9d2d6d9484132025-07-30Warnings, Adverse reactionsName fallback
generic name: DEXTROSE MONOHYDRATE
DextroseDEXTROSE MONOHYDRATEProPharma Distribution3842a9c0-8b15-1c94-e063-6394a90ae1202025-07-18Warnings, Adverse reactionsName fallback
generic name: DEXTROSE MONOHYDRATE
DEXTROSEDEXTROSE MONOHYDRATEBaxter Healthcare Corporation36e9478c-5df0-4b47-b97d-de3626d7cb292025-06-30Warnings, Adverse reactionsName fallback
generic name: DEXTROSE MONOHYDRATE
DextroseDEXTROSE MONOHYDRATEFRESENIUS KABI USA, LLC576a22d8-5f2f-497e-80ad-1842ca74bb532024-08-22Warnings, Adverse reactionsName fallback
generic name: DEXTROSE MONOHYDRATE
DextroseDEXTROSE MONOHYDRATEBecton Dickinson and Companyc1f72bce-4bef-49db-a8da-f26a703d67482024-08-15Warnings, Adverse reactionsName fallback
generic name: DEXTROSE MONOHYDRATE

Reported adverse events (FAERS/openFDA)#

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