FDA.reportPublic FDA data

P32 Sodium Phosphate

Manufacturer
AnazaoHealth Corporation
Effective date
2012-06-19
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 20:16:07

Label at a glance#

ProductP32 Sodium Phosphate
Active ingredientPHOSPHORUS P-32
Label structure6 sections

Indications and uses

P32 sodium phosphate is indicated for the treatment of polycythemia vera and is effective for the treatment of chronic myelocytic leukemia and chronic lymphocytic leukemia. It may also be used in the palliative treatment of selected patients with multiple areas of skeletal metastases Radioactive phosphorous concentrates to a very high degree in rapidly proliferating tissues

Dosage and administration

For polycythemia vera, intravenous dosages from 1 to 8 mCi are usually given depending upon the stage of disease and the size of the patient. Repeat doses must be adjusted to individual needs. For chronic leukemia, the individual dose is 6 to 15 mCi, usually administered with concomitant hormone manipulation

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Dear Medical Professional,

Per your order, we have compounded P32 Sodium Phosphate as a sterile intravenous solution dispensed in a 10 mL plastic vial with a total volume of 4 mL. The characteristics of this preparation are described below.

DESCRIPTION

DESCRIPTION SECTION

AnazaoHealth’s compounded P32 sodium phosphate vial is a sterile, non-pyrogenic radiopharmaceutical. The intravenous solution contains 0.25 N sodium acetate buffer, which is made of 0.9% sodium chloride and 0.09% sodium phosphate dibasic, and is compounded to a total volume of 4 mL. The pH of the solution is between 5 and 6.

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

P32 sodium phosphate is indicated for the treatment of polycythemia vera and is effective for the treatment of chronic myelocytic leukemia and chronic lymphocytic leukemia. It may also be used in the palliative treatment of selected patients with multiple areas of skeletal metastases

Mechanism of Action

Radioactive phosphorous concentrates to a very high degree in rapidly proliferating tissues

CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

P32 sodium phosphate should not be used as part of a sequential treatment with a chemotherapeutic agent. It should not be administered when the leukocyte count is below 5,000/cu mm or a platelet count that is below 150,000/cu mm.

In chronic myelocytic leukemia, it should not be administered when the leukocyte count is below 20,000/cu mm.

For the treatment of bone metastases, it is usually not administered when the leukocyte count is below 5,000/ cu mm and platelet count is below 100,000/cu mm

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

For polycythemia vera, intravenous dosages from 1 to 8 mCi are usually given depending upon the stage of disease and the size of the patient. Repeat doses must be adjusted to individual needs. For chronic leukemia, the individual dose is 6 to 15 mCi, usually administered with concomitant hormone manipulation

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Figure 1

c099d1ae-figure-01
c099d1ae-figure-01

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51808-128-012019-11-27C16284748780-19855d018-d75d-cd31-e053-dbdaa90ab51aP32 Sodium Phosphate

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51808-128-01P32 Sodium Phosphate4 mL in 1 VIALSOLUTION42

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51808-128P32 SODIUM PHOSPHATE SOLUTION [ANAZAOHEALTH CORPORATION]2Legacy NDC, 1 package rows20121015_735f92e3-cc92-4d9b-afe8-f935a685ee78.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
PHOSPHORUS P-32ACTIVE INGREDIENT690284A4072
PHOSPHORUS P-32ACTIVE MOIETY690284A4072
SODIUM ACETATEINACTIVE INGREDIENT4550K0SC9B2

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
51808-12851808-128-01

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
PHOSPHORUS P-32690284A407ACTIB
SODIUM ACETATE4550K0SC9BIACT

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 · 32 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SODIUM ACETATESODIUM ACETATE4550K0SC9BINJECTION, SUSPENSION / INTRAVITREAL0.39 %w/vExact identifier — unii candidate
32 equally ranked IID candidates
SODIUM ACETATESODIUM ACETATE4550K0SC9BINJECTION / INTRAVENOUS4239 mgExact identifier — unii candidate
32 equally ranked IID candidates
SODIUM ACETATESODIUM ACETATE4550K0SC9BINJECTION / SOFT TISSUEADJ PHExact identifier — unii candidate
32 equally ranked IID candidates
SODIUM ACETATESODIUM ACETATE4550K0SC9BSYRUP / ORAL43 mgExact identifier — unii candidate
32 equally ranked IID candidates
SODIUM ACETATESODIUM ACETATE4550K0SC9BPOWDER, FOR SOLUTION / ORAL0.1 mgExact identifier — unii candidate
32 equally ranked IID candidates
SODIUM ACETATESODIUM ACETATE4550K0SC9BCREAM / TOPICALNAExact identifier — unii candidate
32 equally ranked IID candidates
SODIUM ACETATESODIUM ACETATE4550K0SC9BSOLUTION / INTRAVENOUS20 mgExact identifier — unii candidate
32 equally ranked IID candidates
SODIUM ACETATESODIUM ACETATE4550K0SC9BINJECTION, SOLUTION / SUBMUCOSAL0.08 %w/vExact identifier — unii candidate
32 equally ranked IID candidates
SODIUM ACETATESODIUM ACETATE4550K0SC9BSOLUTION/ DROPS / OPHTHALMIC1.24 %w/vExact identifier — unii candidate
32 equally ranked IID candidates
SODIUM ACETATESODIUM ACETATE4550K0SC9BEMULSION / OPHTHALMIC0.08 %w/vExact identifier — unii candidate
32 equally ranked IID candidates
SODIUM ACETATESODIUM ACETATE4550K0SC9BSOLUTION/ DROPS / AURICULAR (OTIC)0.03 %w/wExact identifier — unii candidate
32 equally ranked IID candidates
SODIUM ACETATESODIUM ACETATE4550K0SC9BINJECTION / INTRADERMAL1.6 mgExact identifier — unii candidate
32 equally ranked IID candidates
SODIUM ACETATESODIUM ACETATE4550K0SC9BSUSPENSION/ DROPS / AURICULAR (OTIC)0.03 %w/vExact identifier — unii candidate
32 equally ranked IID candidates
SODIUM ACETATESODIUM ACETATE4550K0SC9BINJECTION / INTRA-ARTICULARADJ PHExact identifier — unii candidate
32 equally ranked IID candidates
SODIUM ACETATESODIUM ACETATE4550K0SC9BSOLUTION / AURICULAR (OTIC)0.02 %w/vExact identifier — unii candidate
32 equally ranked IID candidates
SODIUM ACETATESODIUM ACETATE4550K0SC9BLIQUID / SUBCUTANEOUS0.2 %w/vExact identifier — unii candidate
32 equally ranked IID candidates
SODIUM ACETATESODIUM ACETATE4550K0SC9BLIQUID / INTRAVENOUS0.2 %w/vExact identifier — unii candidate
32 equally ranked IID candidates
SODIUM ACETATESODIUM ACETATE4550K0SC9BINJECTION, SOLUTION / INTRAVENOUS328 mgExact identifier — unii candidate
32 equally ranked IID candidates
SODIUM ACETATESODIUM ACETATE4550K0SC9BSOLUTION / TOPICALNAExact identifier — unii candidate
32 equally ranked IID candidates
SODIUM ACETATESODIUM ACETATE4550K0SC9BINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / PARENTERAL250 mgExact identifier — unii candidate
32 equally ranked IID candidates
SODIUM ACETATESODIUM ACETATE4550K0SC9BINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS141 mgExact identifier — unii candidate
32 equally ranked IID candidates
SODIUM ACETATESODIUM ACETATE4550K0SC9BINJECTION / INTRACAVITARY0.1 mlExact identifier — unii candidate
32 equally ranked IID candidates
SODIUM ACETATESODIUM ACETATE4550K0SC9BINJECTION, POWDER, FOR SOLUTION / PARENTERAL12.5 mgExact identifier — unii candidate
32 equally ranked IID candidates
SODIUM ACETATESODIUM ACETATE4550K0SC9BINJECTION, SOLUTION / SUBCUTANEOUS0.16 %w/vExact identifier — unii candidate
32 equally ranked IID candidates
SODIUM ACETATESODIUM ACETATE4550K0SC9BSOLUTION / OPHTHALMIC2 mgExact identifier — unii candidate
32 equally ranked IID candidates
SODIUM ACETATESODIUM ACETATE4550K0SC9BSUSPENSION / AURICULAR (OTIC)0.68 %w/vExact identifier — unii candidate
32 equally ranked IID candidates
SODIUM ACETATESODIUM ACETATE4550K0SC9BINJECTION / INTRAMUSCULAR19 mgExact identifier — unii candidate
32 equally ranked IID candidates
SODIUM ACETATESODIUM ACETATE4550K0SC9BINJECTION / INTRASYNOVIALADJ PHExact identifier — unii candidate
32 equally ranked IID candidates
SODIUM ACETATESODIUM ACETATE4550K0SC9BSOLUTION / ORAL44 mgExact identifier — unii candidate
32 equally ranked IID candidates
SODIUM ACETATESODIUM ACETATE4550K0SC9BSOLUTION / INTRAOCULAR195 mgExact identifier — unii candidate
32 equally ranked IID candidates
SODIUM ACETATESODIUM ACETATE4550K0SC9BINJECTION / INTRALESIONALADJ PHExact identifier — unii candidate
32 equally ranked IID candidates
SODIUM ACETATESODIUM ACETATE4550K0SC9BINJECTION / SUBCUTANEOUS19 mgExact identifier — unii candidate
32 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
c099d1ae-d9f6-4176-b55c-233ce52b2976735f92e3-cc92-4d9b-afe8-f935a685ee782012-06-19Exact identifier
spl id: c099d1ae-d9f6-4176-b55c-233ce52b2976
spl set id: 735f92e3-cc92-4d9b-afe8-f935a685ee78

Reported adverse events (FAERS/openFDA)#

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