FDA.reportPublic FDA data

Sodium Phosphates

Product NDC
0517-7350
11-digit product format
005177350
Labeler code
0517
Product ID
0517-7350_4b71a79f-83da-45b0-a398-4833ecc17ba4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sodium phosphate, monobasic, monohydrate and sodium phosphate, dibasic anhydrous
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
American Regent, Inc.
Application
ANDA218314
Marketing category
ANDA
Marketing start
2024-06-21
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
Unii593YOG76RN, 22ADO53M6F
Rxcui1872384, 1872443, 1872447

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
0517-7350-01Sodium Phosphates50 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION502
0517-7350-25Sodium Phosphates25 in 1 TRAYINJECTION, SOLUTION252

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0517-7350-01ML - Milliliter0517-7350797aaa5b-d8bf-453f-ab3c-7b007f5c20b912024-07-12
0517-7350-25ML - Milliliter0517-735094c1ab95-3cca-4b93-b3d8-13d5d2981ec712024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0517-7350SODIUM PHOSPHATES (SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE AND SODIUM PHOSPHATE, DIBASIC ANHYDROUS) INJECTION, SOLUTION [AMERICAN REGENT, INC.]2Current NDC, 2 package rows20240625_dc0462ee-4486-418c-865f-e2a71bdb8e9e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1872443sodium phosphates (phosphorus 15 MMOL / sodium 20 MEQ) in 5 ML InjectionPSNdc0462ee-4486-418c-865f-e2a71bdb8e9e2
1872447sodium phosphates (phosphorus 150 MMOL / sodium 200 MEQ) in 50 ML InjectionPSNdc0462ee-4486-418c-865f-e2a71bdb8e9e2
1872384sodium phosphates (phosphorus 45 MMOL / sodium 60 MEQ) in 15 ML InjectionPSNdc0462ee-4486-418c-865f-e2a71bdb8e9e2
187238415 ML sodium phosphate, dibasic 142 MG/ML / sodium phosphate, monobasic 276 MG/ML InjectionSCDdc0462ee-4486-418c-865f-e2a71bdb8e9e2
18724435 ML sodium phosphate, dibasic 142 MG/ML / sodium phosphate, monobasic 276 MG/ML InjectionSCDdc0462ee-4486-418c-865f-e2a71bdb8e9e2
187244750 ML sodium phosphate, dibasic 142 MG/ML / sodium phosphate, monobasic 276 MG/ML InjectionSCDdc0462ee-4486-418c-865f-e2a71bdb8e9e2
1872384phosphorus 45 MMOL / sodium 60 MEQ per 15 ML InjectionSYdc0462ee-4486-418c-865f-e2a71bdb8e9e2
1872384sodium phosphate, dibasic 2.13 GM / sodium phosphate, monobasic 4.14 GM per 15 ML InjectionSYdc0462ee-4486-418c-865f-e2a71bdb8e9e2
1872443sodium phosphates (phosphorus 15 MMOL / sodium 20 MEQ) per 5 ML InjectionSYdc0462ee-4486-418c-865f-e2a71bdb8e9e2
1872447sodium phosphates (phosphorus 150 MMOL / sodium 200 MEQ) per 50 ML InjectionSYdc0462ee-4486-418c-865f-e2a71bdb8e9e2
1872384sodium phosphates (phosphorus 45 MMOL / sodium 60 MEQ) per 15 ML InjectionSYdc0462ee-4486-418c-865f-e2a71bdb8e9e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0517-7350-010051773500150 mL in 1 VIAL, SINGLE-DOSE50 mlHistorical
0517-7350-250051773502525 VIAL, SINGLE-DOSE in 1 TRAY (0517-7350-25) / 50 mL in 1 VIAL, SINGLE-DOSE (0517-7350-01) 2024-06-21NoNoCurrent