FDA.reportPublic FDA data

Dextrose

Manufacturer
IBA Inc. | Nova-Tech, Inc.
Effective date
2018-01-16
Label type
OTC ANIMAL DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:40:09

Label at a glance#

ProductDextrose
Active ingredientDEXTROSE MONOHYDRATE
Label structure11 sections

Dosage and administration

The usual dose is 50 mL per 100 lbs. of body weight. May be repeat- ed in 8 to 10 hours or on successive days. For intravenous use only.

Storage and handling

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

Label contents#

Full prescribing information#

INDICATIONS:

INDICATIONS & USAGE SECTION

As a treatment of uncomplicated pri-
mary ketosis in cattle.

DOSAGE and ADMINISTRATION:

DOSAGE & ADMINISTRATION SECTION

The usual dose is 50 mL per 100
lbs. of body weight. May be repeat-
ed in 8 to 10 hours or on successive
days. For intravenous use only.

VETERINARY INDICATIONS SECTION

FOR VETERINARY USE ONLY

STORAGE AND HANDLING SECTION

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

WARNINGS AND PRECAUTIONS SECTION

TAKE TIME OBSERVE LABEL DIRECTIONS

CONTAINS:

DOSAGE FORMS & STRENGTHS SECTION

Dextrose • H2O, 50% w/v
Water For Injection ....................... q.s.

WARNINGS SECTION

KEEP OUT OF REACH OF CHILDREN

NOTE:

INFORMATION FOR OWNERS/CAREGIVERS SECTION

If there is no noticeable
improvement in the condition being
treated after 3 of 4 days of treat-
ment, consult your veterinarian.
Aseptic precautions should be
observed such as using sterile nee-
dle and syringe. Disinfect the site of
injection.

CAUTION:

PRECAUTIONS SECTION

Solution should be
warmed to body temperature and
administered slowly. This product
contains no preservative. Entire con-
tents should be used upon entering.
Discard any unused portion.

INFORMATION FOR OWNERS/CAREGIVERS SECTION

IBA STOCK #494302

09NT6 

Rev. 05-09

18-801-50

RMS 92-554

STERILE

NET CONTENTS: 500 mL

MANUFACTURED FOR:
IBA INC.
ANIMAL HEALTH DIVISION
27 PROVIDENCE RD.
MILLBURY, MA 01527

LOT NO.:

EXP. DATE:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

500 PRODUCT LABEL500 PRODUCT 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
29983-2403-1Dextrose500 mL in 1 BOTTLE, PLASTICINJECTION, SOLUTION5001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
29983-2403DEXTROSE INJECTION, SOLUTION [IBA INC.]11 package rows20180119_fa7e0a20-3da9-40a8-b398-244eac650aec.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
29983-240329983-2403-1

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.