Pyrophosphate

Manufacturer
AnazaoHealth Corporation
Effective date
2012-05-23
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 20:16:07

Label at a glance#

ProductPyrophosphate
Active ingredientSODIUM PYROPHOSPHATE
Label structure5 sections

Indications and uses

Stannous Pyrophosphate is indicated as a blood pool imaging agent which may be used for gated pool imaging and for the detection of sites of gastrointestinal bleeding. When administered intravenously, 15-30 minutes prior to intravenous administration of sodium pertechnetate Tc99m for in vivo red blood cell labeling, approximately 75 percent of the injected activity remains in the blood pool. The modified in vivo/i...

Dosage and administration

The recommended adult dose of Tc99m Pyrophosphate Injection is: 5 to 15 mCi for skeletal imaging 10 to 15 mCi for cardiac imaging one-third (0.33) to the entire vial contents, followed 15 to 20 mCi of sodium pertechnetate Tc 99m, for blood pool imaging

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Dear Medical Professional,

Per your order, we have compounded Stannous-Pyrophosphate as a sterile lyophilized powder. The characteristics of this preparation are:

DESCRIPTION

DESCRIPTION SECTION

AnazaoHealth compounds Stannous-Pyrophosphate as a sterile lyophilized powder for the preparation of Tc99m Pyrophosphate. Each 10 ml reaction vial contains: 27.6 milligrams sodium pyrophosphate decahydrate, 3.5 milligrams stannous chloride, all lyophilized under an atmosphere of nitrogen. Prior to lyophilization the pH is adjusted with hydrochloric acid. The pH of the reconstituted drug is between 4.5 and 7.5. No bacteriostatic preservative is present

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

Stannous Pyrophosphate is indicated as a blood pool imaging agent which may be used for gated pool imaging and for the detection of sites of gastrointestinal bleeding. When administered intravenously, 15-30 minutes prior to intravenous administration of sodium pertechnetate Tc99m for in vivo red blood cell labeling, approximately 75 percent of the injected activity remains in the blood pool. The modified in vivo/in vitro red blood cell labeling method may also be used for blood pool imaging.

It is also indicated as a skeletal imaging agent used to demonstrate areas of altered osteogenesis, and a cardiac imaging agent used as an adjunct in the diagnosis of acute myocardial infarction.

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

The recommended adult dose of Tc99m Pyrophosphate Injection is:

  • 5 to 15 mCi for skeletal imaging
  • 10 to 15 mCi for cardiac imaging
  • one-third (0.33) to the entire vial contents, followed 15 to 20 mCi of sodium pertechnetate Tc 99m, for blood pool imaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Figure 1

e247d821-figure-01
e247d821-figure-01

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51808-218-012019-11-27C16284748780-19855d018-e180-cd31-e053-dbdaa90ab51aStannous Pyrophosphate

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51808-218-01Pyrophosphate1 in 1 KITINJECTION, POWDER, LYOPHILIZED,11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51808-218PYROPHOSPHATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ANAZAOHEALTH CORPORATION]1Legacy NDC, 1 package rows20121015_30046b6b-09ea-46b1-8e60-61c53e1e7282.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
SODIUM PYROPHOSPHATEACTIVE INGREDIENTO352864B8Z1
PYROPHOSPHORIC ACIDACTIVE MOIETY4E862E7GRQ1
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
51808-21851808-218-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM PYROPHOSPHATEO352864B8ZACTIB
STANNOUS CHLORIDE1BQV3749L5IACT

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 · 5 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
STANNOUS CHLORIDESTANNOUS CHLORIDE1BQV3749L5INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS0.42 mgExact identifier — unii candidate
5 equally ranked IID candidates
STANNOUS CHLORIDESTANNOUS CHLORIDE1BQV3749L5INJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS0.08 mgExact identifier — unii candidate
5 equally ranked IID candidates
STANNOUS CHLORIDESTANNOUS CHLORIDE1BQV3749L5INJECTION / INTRAVENOUS3.4 mgExact identifier — unii candidate
5 equally ranked IID candidates
STANNOUS CHLORIDESTANNOUS CHLORIDE1BQV3749L5INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS0.25 mgExact identifier — unii candidate
5 equally ranked IID candidates
STANNOUS CHLORIDESTANNOUS CHLORIDE1BQV3749L5INJECTION, POWDER, FOR SOLUTION / INTRADERMAL0.08 mgExact identifier — unii candidate
5 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
e247d821-b132-4a87-a71a-8bc13c71fcfc30046b6b-09ea-46b1-8e60-61c53e1e72822012-05-23Exact identifier
spl id: e247d821-b132-4a87-a71a-8bc13c71fcfc
spl set id: 30046b6b-09ea-46b1-8e60-61c53e1e7282

Reported adverse events (FAERS/openFDA)#

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