FDA.reportPublic FDA data

Dextran 75

Manufacturer
AnazaoHealth Corporation
Effective date
2012-07-01
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 20:16:20

Label at a glance#

ProductDextran 75
Active ingredientDEXTRAN 75
Label structure5 sections

Indications and uses

Technetium Tc99m Dextran by intravenous administration is indicated as a cardiac blood pool imaging agent and as an adjunct in the diagnosis of pericardial effusion, ventricular aneurysm, or GI Bleed

Dosage and administration

To prepare injection, up to 40 mCi of an oxidant-free sodium pertechnetate Tc 99m solution is aseptically injected into the vial, minimum volume 1ml, mix gently and let Dextran dissolve completely for 10 minutes Injection should be administered within 6 hours after preparation. Before and after reconstitution- Store at room temperature

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Dear Medical Professional,

Per your order, we have compounded Dextran 75 as a lyophilized powder for injection. The characteristics of this preparation are as follows:

DESCRIPTION

DESCRIPTION SECTION

AnazaoHealth supplies compounded Dextran 75 for the preparation of Tc-99m Dextran 75. Each reaction vial contains 10 mg of Dextran 75, 0.30mg of stannous chloride, 0.73 mg Sodium Citrate and 1 mg of dextrose (lyophilized mixture, under nitrogen atmosphere), per unit dose vial.

Mechanism of Action

Dextran, when labeled with technetium Tc99m and given intravenously, is distributed throughout the body in much the same way as the patient’s serum, and serves as a suitable tracer with which to transiently image the vascular compartment

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

Technetium Tc99m Dextran by intravenous administration is indicated as a cardiac blood pool imaging agent and as an adjunct in the diagnosis of pericardial effusion, ventricular aneurysm, or GI Bleed

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

To prepare injection, up to 40 mCi of an oxidant-free sodium pertechnetate Tc 99m solution is aseptically injected into the vial, minimum volume 1ml, mix gently and let Dextran dissolve completely for 10 minutes

Storage and Handling

Injection should be administered within 6 hours after preparation. Before and after reconstitution- Store at room temperature

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Figure 1

29c1fd45-figure-01
29c1fd45-figure-01

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTRAN 75 Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51808-210-012019-11-27C16284748780-19855d018-d3f4-cd31-e053-dbdaa90ab51aDextran 75

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51808-210-01Dextran 751 in 1 KITINJECTION, POWDER, LYOPHILIZED,11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51808-210DEXTRAN 75 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ANAZAOHEALTH CORPORATION]1Legacy NDC, 1 package rows20121203_a71129ae-8266-4064-a3f5-6f2897e62981.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
DEXTRAN 75ACTIVE INGREDIENTJY83SHX0531
DEXTRAN 75ACTIVE MOIETYJY83SHX0531
ANHYDROUS DEXTROSEINACTIVE INGREDIENT5SL0G7R0OK1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULR1
STANNOUS CHLORIDEINACTIVE INGREDIENT1BQV3749L51

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
51808-21051808-210-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
DEXTRAN 75JY83SHX053ACTIB
STANNOUS CHLORIDE1BQV3749L5IACT
ANHYDROUS DEXTROSE5SL0G7R0OKIACT
SODIUM CITRATE1Q73Q2JULRIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 19 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ANHYDROUS DEXTROSEANHYDROUS DEXTROSE5SL0G7R0OKINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS3.9 %w/vExact identifier — unii candidate
14 equally ranked IID candidates
ANHYDROUS DEXTROSEANHYDROUS DEXTROSE5SL0G7R0OKPOWDER / ORAL0.5 mgExact identifier — unii candidate
14 equally ranked IID candidates
ANHYDROUS DEXTROSEANHYDROUS DEXTROSE5SL0G7R0OKSUSPENSION / ORAL17406 mgExact identifier — unii candidate
14 equally ranked IID candidates
STANNOUS CHLORIDESTANNOUS CHLORIDE1BQV3749L5INJECTION / INTRAVENOUS3.4 mgExact identifier — unii candidate
5 equally ranked IID candidates
ANHYDROUS DEXTROSEANHYDROUS DEXTROSE5SL0G7R0OKINJECTION / INTRAVENOUS36000 mgExact identifier — unii candidate
14 equally ranked IID candidates
STANNOUS CHLORIDESTANNOUS CHLORIDE1BQV3749L5INJECTION, POWDER, FOR SOLUTION / INTRADERMAL0.08 mgExact identifier — unii candidate
5 equally ranked IID candidates
ANHYDROUS DEXTROSEANHYDROUS DEXTROSE5SL0G7R0OKSPRAY / NASAL36 mgExact identifier — unii candidate
14 equally ranked IID candidates
STANNOUS CHLORIDESTANNOUS CHLORIDE1BQV3749L5INJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS0.08 mgExact identifier — unii candidate
5 equally ranked IID candidates
ANHYDROUS DEXTROSEANHYDROUS DEXTROSE5SL0G7R0OKINJECTION / INTRASPINAL8.25 %w/vExact identifier — unii candidate
14 equally ranked IID candidates
ANHYDROUS DEXTROSEANHYDROUS DEXTROSE5SL0G7R0OKINJECTION, SOLUTION / INTRAVENOUS3187 mgExact identifier — unii candidate
14 equally ranked IID candidates
STANNOUS CHLORIDESTANNOUS CHLORIDE1BQV3749L5INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS0.25 mgExact identifier — unii candidate
5 equally ranked IID candidates
ANHYDROUS DEXTROSEANHYDROUS DEXTROSE5SL0G7R0OKSPRAY, METERED / NASAL40 mgExact identifier — unii candidate
14 equally ranked IID candidates
ANHYDROUS DEXTROSEANHYDROUS DEXTROSE5SL0G7R0OKTABLET, EXTENDED RELEASE / ORAL30 mgExact identifier — unii candidate
14 equally ranked IID candidates
ANHYDROUS DEXTROSEANHYDROUS DEXTROSE5SL0G7R0OKINJECTION / SUBCUTANEOUS7.5 %w/vExact identifier — unii candidate
14 equally ranked IID candidates
ANHYDROUS DEXTROSEANHYDROUS DEXTROSE5SL0G7R0OKINJECTION / INTRAMUSCULAR300 mgExact identifier — unii candidate
14 equally ranked IID candidates
ANHYDROUS DEXTROSEANHYDROUS DEXTROSE5SL0G7R0OKGRANULE, FOR SUSPENSION / ORAL16878 mgExact identifier — unii candidate
14 equally ranked IID candidates
ANHYDROUS DEXTROSEANHYDROUS DEXTROSE5SL0G7R0OKINJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR3.9 %w/vExact identifier — unii candidate
14 equally ranked IID candidates
STANNOUS CHLORIDESTANNOUS CHLORIDE1BQV3749L5INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS0.42 mgExact identifier — unii candidate
5 equally ranked IID candidates
ANHYDROUS DEXTROSEANHYDROUS DEXTROSE5SL0G7R0OKTABLET, CHEWABLE / ORAL1592 mgExact identifier — unii candidate
14 equally ranked IID candidates

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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
29c1fd45-7d77-4882-9e73-8a66742be742a71129ae-8266-4064-a3f5-6f2897e629812012-07-01Exact identifier
spl id: 29c1fd45-7d77-4882-9e73-8a66742be742
spl set id: a71129ae-8266-4064-a3f5-6f2897e62981

Reported adverse events (FAERS/openFDA)#

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