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, DIBASIC, ANHYDROUS142 mg/mL
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE276 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii22ADO53M6F, 593YOG76RN
Rxcui1872384, 1872443

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

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