FDA.reportPublic FDA data

Dextrose Solution 50%

Manufacturer
Covetrus | Nova-Tech, Inc.
Effective date
2023-12-27
Label type
OTC ANIMAL DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 02:42:43

Label at a glance#

ProductDextrose
Active ingredientDEXTROSE MONOHYDRATE
Label structure10 sections

Dosage and administration

Administer 50 mL per 100 lbs of body weight intravenously only. Dosage may be repeated in 8 to 10 hours or on successive days as needed. 

Storage and handling

Store between 15°C and 30°C (59°F-86°F).

Label contents#

Full prescribing information#

Dosage And Administration:

DOSAGE & ADMINISTRATION SECTION

Administer 50 mL per 100 lbs of body weight intravenously only. Dosage may be repeated in 8 to 10 hours or on successive days as needed. 

Caution:

PRECAUTIONS SECTION

This product should be warmed to body temperature and administered slowly. This product contains no preservative. 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 Monohydrate ..........................50 % w/v

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

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

STORAGE AND HANDLING SECTION

Store between 15°C and 30°C (59°F-86°F).

GENERAL PRECAUTIONS SECTION

TAKE TIME OBSERVE LABEL DIRECTIONS

INFORMATION FOR OWNERS/CAREGIVERS SECTION

NDC: 11695-1597-3

18-801
RMS 92-1024

Volume: 16.907 (500 mL)

Questions? (855) 724-3461

Reorder #069168

Manufactured by:
Nova-Tech, Inc.
Grand Island, NE 68801

Distributed by:
Covetrus North America

400 Metro Place North

Dublin, OH 43017

covetrus.com

Made in the USA

AH-069168-L-02
Rev: 0523

Lot No.               Exp. Date

Indications:

INDICATIONS & USAGE SECTION

For use in cattle as an aid in the treatment of uncomplicated primary ketosis.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Dextrose 500 mL
Dextrose 500 mL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
237653dextrose 50 % Injectable SolutionPSN4
237653glucose 500 MG/ML Injectable SolutionSCD4
237653dextrose 50 % Injectable SolutionSY4
237653dextrose 500 MG/ML Injectable SolutionSY4

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
11695-1597-3Dextrose500 mL in 1 BOTTLE, PLASTICINJECTION, SOLUTION5004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11695-1597DEXTROSE INJECTION, SOLUTION [COVETRUS]41 package rows20231228_8955a87b-f159-4cda-95b6-e866f30567de.zip

Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11695-159711695-1597-3

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

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 · 39 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
brand name: Dextrose
generic name: DEXTROSE MONOHYDRATE
DextroseDEXTROSE MONOHYDRATEREMEDYREPACK INC.b8b77421-d687-45aa-82f6-d49bce644c102026-08-31Warnings, Adverse reactionsName fallback
brand name: Dextrose
generic name: DEXTROSE MONOHYDRATE
DextroseDEXTROSE MONOHYDRATEHospira, Inc.4ed365da-4e62-4329-c1b9-c197ab4fb6e12026-07-13Warnings, Adverse reactionsName fallback
brand name: Dextrose
generic name: DEXTROSE MONOHYDRATE
DextroseDEXTROSE MONOHYDRATEHospira, Inc.672264e3-9709-4bba-2a9d-12bf70c7396a2026-06-24Warnings, Adverse reactionsName fallback
brand name: Dextrose
generic name: DEXTROSE MONOHYDRATE
DEXTROSEDEXTROSE MONOHYDRATEBaxter Healthcare Corporation3bb406a9-f5cb-403a-b1bb-5c4facbea3d52026-06-11Warnings, Adverse reactionsName fallback
brand name: DEXTROSE
generic name: DEXTROSE MONOHYDRATE
DextroseDEXTROSE MONOHYDRATEHospira, Inc.10e98cb0-31a5-4ad1-3eaa-aa4af387a42d2026-06-02Warnings, Adverse reactionsName fallback
brand name: Dextrose
generic name: DEXTROSE MONOHYDRATE
DextroseDEXTROSEB. Braun Medical Inc.60b6d7c3-0164-46c9-aa38-b5aa1c31a5d52026-05-12Warnings, Adverse reactionsName fallback
brand name: Dextrose
DextroseDEXTROSE MONOHYDRATEHenry Schein, Inc.40fd1ac4-39bb-45fb-ba99-4fb65481f2312026-04-09Warnings, Adverse reactionsName fallback
brand name: Dextrose
generic name: DEXTROSE MONOHYDRATE
DextroseDEXTROSE MONOHYDRATEBecton Dickinson and Company8e7046f8-841e-465a-af69-af9fb3d6799d2026-03-17Warnings, Adverse reactionsName fallback
brand name: Dextrose
generic name: DEXTROSE MONOHYDRATE
DEXTROSEDEXTROSEHF Acquisition Co. LLC. DBA HealthFirst4d2d3d3d-d96e-4005-e063-6394a90afd9a2026-03-16Warnings, Adverse reactionsName fallback
brand name: DEXTROSE
DextroseDEXTROSE MONOHYDRATEFresenius Kabi USA, LLC3b8f2692-4371-4f1a-95af-b41842131fdd2026-03-13Warnings, Adverse reactionsName fallback
brand name: Dextrose
generic name: DEXTROSE MONOHYDRATE
DextroseDEXTROSE MONOHYDRATEBECTON DICKINSON AND COMPANY32132016-1870-481b-9816-e11beb03ca0b2026-01-08Warnings, Adverse reactionsName fallback
brand name: Dextrose
generic name: DEXTROSE MONOHYDRATE
DextroseDEXTROSE MONOHYDRATEFresenius Kabi USA, LLCbd250a46-d229-4e80-b5a1-b34169ccecc42025-12-17Warnings, Adverse reactionsName fallback
brand name: Dextrose
generic name: DEXTROSE MONOHYDRATE
DextroseDEXTROSE MONOHYDRATEICU Medical, Inc.8b25b7e0-703e-4b43-a4eb-52863511602d2025-11-02Warnings, Adverse reactionsName fallback
brand name: Dextrose
generic name: DEXTROSE MONOHYDRATE
DextroseDEXTROSEICU Medical Inc.b5cb7a5a-bbe8-4217-a82e-da818f7771c92025-11-02Warnings, Adverse reactionsName fallback
brand name: Dextrose
DextroseDEXTROSE MONOHYDRATEICU Medical, Inc.cb578dba-094c-4787-951d-763d12fd06e12025-11-01Warnings, Adverse reactionsName fallback
brand name: Dextrose
generic name: DEXTROSE MONOHYDRATE
DextroseDEXTROSE MONOHYDRATEICU Medical Inc.cdf35d11-fbc8-4f8e-85a8-33220312c0b42025-10-17Warnings, Adverse reactionsName fallback
brand name: Dextrose
generic name: DEXTROSE MONOHYDRATE
DextroseDEXTROSE MONOHYDRATEProPharma Distribution3eff8bcd-6a33-428f-e063-6394a90afa682025-09-17Warnings, Adverse reactionsName fallback
brand name: Dextrose
generic name: DEXTROSE MONOHYDRATE
DextroseDEXTROSE MONOHYDRATEBaxter Healthcare Companybfc4224a-2fc9-4137-b4c6-9d2d6d9484132025-07-30Warnings, Adverse reactionsName fallback
brand name: Dextrose
generic name: DEXTROSE MONOHYDRATE
DextroseDEXTROSE MONOHYDRATEProPharma Distribution3842a9c0-8b15-1c94-e063-6394a90ae1202025-07-18Warnings, Adverse reactionsName fallback
brand name: Dextrose
generic name: DEXTROSE MONOHYDRATE

Reported adverse events (FAERS/openFDA)#

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