FDA.reportPublic FDA data

Dextrose

Manufacturer
Bimeda, Inc. | Bimeda-MTC Animal Health
Effective date
2021-12-22
Label type
OTC ANIMAL DRUG LABEL
Version
10
Source
full-release
Hydrated at
2026-06-01 02:41:14

Label at a glance#

ProductDextrose
Active ingredientDEXTROSE MONOHYDRATE
Label structure5 sections

Storage and handling

STORAGE: STORE BETWEEN 15°C-30°C (59°F-86°F).

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

INDICATIONS:

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

DOSAGE & ADMINISTRATION SECTION

DOSAGE AND ADMINISTRATION:

Cattle:  100 to 500 mL depending on size and condition of animal.  For intravenous use only.  Solution should be warmed to body temperature and administered slowly.  This product is sterile in unopened container.  Contains no preservative.  If entire contents are not used, discard unused portion.  Handle under strict aseptic conditions.

DESCRIPTION SECTION

COMPOSITION:

Each 100 mL contains:

Dextrose Monohydrate ...............50 g

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

May contain hydrochloric acid or sodium hydroxide for pH adjustment.

2525 m0smol/liter (Calculated)

Caloric Value per liter:  1700

Hypertonic                       pH 3.5-6.5

STORAGE AND HANDLING SECTION

STORAGE:

STORE BETWEEN 15°C-30°C (59°F-86°F).

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
237653dextrose 50 % Injectable SolutionPSN10
237653glucose 500 MG/ML Injectable SolutionSCD10
237653dextrose 50 % Injectable SolutionSY10
237653dextrose 500 MG/ML Injectable SolutionSY10

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
61133-0295-5Dextrose500 mL in 1 VIALINJECTION50010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61133-0295DEXTROSE (DEXTROSE MONOHYDRATE) INJECTION [BIMEDA, INC.]101 package rows20211223_fe922f5f-61be-4f1e-8995-601c068e2f82.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
61133-029561133-0295-5

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 · 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.