FDA.reportPublic FDA data

Sodium Phosphates

Product NDC
63323-170
11-digit product format
633230170
Labeler code
63323
Product ID
63323-170_38669b97-6c71-410e-bccc-a991a25ff64f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Fresenius Kabi USA, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2000-09-06
Substance
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE
Active strength
142; 276 mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sodium Phosphates
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE142 mg/mL
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS276 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
593YOG76RNInternal UNII lookup
22ADO53M6FInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1872384Internal RxNorm lookup
1872443Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
e6169d3b-39d2-47f9-8d5b-b53ec069a722Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
4b7700e3-6e0e-45e5-9d22-6f754d61386eProduct name220250304
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63323-170-05Sodium Phosphates5 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION54
63323-170-05Sodium Phosphates25 in 1 TRAYINJECTION, SOLUTION254
63323-170-15Sodium Phosphates15 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION154
63323-170-15Sodium Phosphates25 in 1 TRAYINJECTION, SOLUTION254

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-170-05ML - Milliliter63323-1702fc7628a-815b-4ef1-8965-71aae092785112014-02-04
63323-170-15ML - Milliliter63323-1702eb3d5e5-8be2-4f3d-b837-b11ccea44d0312014-02-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSACTIVE INGREDIENT22ADO53M6FSODIUM PHOSPHATES (SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEACTIVE INGREDIENT593YOG76RNSODIUM PHOSPHATES (SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
PHOSPHATE IONACTIVE MOIETYNK08V8K8HRSODIUM PHOSPHATES (SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
PHOSPHORIC ACIDINACTIVE INGREDIENTE4GA8884NNSODIUM PHOSPHATES (SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ISODIUM PHOSPHATES (SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-170SODIUM PHOSPHATES (SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]4Current NDC, Legacy NDC, 4 package rows20210729_e6169d3b-39d2-47f9-8d5b-b53ec069a722.zip

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
Sodium PhosphatesSODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEFresenius Kabi USA, LLCe6169d3b-39d2-47f9-8d5b-b53ec069a7222021-07-23Warnings, Adverse reactionsExact identifier
ndc (product): 63323-170

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1872443sodium phosphates (phosphorus 15 MMOL / sodium 20 MEQ) in 5 ML InjectionPSNe6169d3b-39d2-47f9-8d5b-b53ec069a7224
1872384sodium phosphates (phosphorus 45 MMOL / sodium 60 MEQ) in 15 ML InjectionPSNe6169d3b-39d2-47f9-8d5b-b53ec069a7224
187238415 ML sodium phosphate, dibasic 142 MG/ML / sodium phosphate, monobasic 276 MG/ML InjectionSCDe6169d3b-39d2-47f9-8d5b-b53ec069a7224
18724435 ML sodium phosphate, dibasic 142 MG/ML / sodium phosphate, monobasic 276 MG/ML InjectionSCDe6169d3b-39d2-47f9-8d5b-b53ec069a7224
1872384phosphorus 45 MMOL / sodium 60 MEQ per 15 ML InjectionSYe6169d3b-39d2-47f9-8d5b-b53ec069a7224
1872384sodium phosphate, dibasic 2.13 GM / sodium phosphate, monobasic 4.14 GM per 15 ML InjectionSYe6169d3b-39d2-47f9-8d5b-b53ec069a7224
1872443sodium phosphates (phosphorus 15 MMOL / sodium 20 MEQ) per 5 ML InjectionSYe6169d3b-39d2-47f9-8d5b-b53ec069a7224
1872384sodium phosphates (phosphorus 45 MMOL / sodium 60 MEQ) per 15 ML InjectionSYe6169d3b-39d2-47f9-8d5b-b53ec069a7224

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63323-170-056332301700525 VIAL, SINGLE-DOSE in 1 TRAY (63323-170-05) / 5 mL in 1 VIAL, SINGLE-DOSE2000-09-060000-00-00NoNoCurrent
63323-170-156332301701525 VIAL, SINGLE-DOSE in 1 TRAY (63323-170-15) / 15 mL in 1 VIAL, SINGLE-DOSE2000-09-060000-00-00NoNoCurrent