Sodium Phosphates

Product NDC
63323-881
11-digit product format
633230881
Labeler code
63323
Product ID
63323-881_3ae3c9a3-3503-4264-8c77-00089f50cc74
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sodium phosphate, monobasic, monohydrate and sodium phosphate, dibasic, anhydrous
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Fresenius Kabi USA, LLC
Application
ANDA209997
Marketing category
ANDA
Marketing start
2022-03-30
Substance
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE
Active strength
142; 276 mg/mL; mg/mL
Pharmacologic classes
Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]
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, 1872447

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
95250459-30e4-45c1-b08a-993044f49109Product name220250805
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
4b7700e3-6e0e-45e5-9d22-6f754d61386eProduct name220250304
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
a21a21e5-f36d-4c1f-8918-def921b8f7e3Product name320250124
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63323-881-01Sodium Phosphates15 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION155
63323-881-16Sodium Phosphates25 in 1 TRAYINJECTION, SOLUTION255

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-881-01ML - Milliliter63323-881d4e1d1d8-fd81-4b21-a297-c8c78baa0fba12022-08-04
63323-881-16ML - Milliliter63323-881099bb0e7-15e1-4ff0-a5f7-4e2d77a115be12022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-881SODIUM PHOSPHATES (SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE AND SODIUM PHOSPHATE, DIBASIC, ANHYDROUS) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]5Current NDC, Legacy NDC, 2 package rows20220405_5bf47be3-f3fe-452b-8113-941796498345.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1872443sodium phosphates (phosphorus 15 MMOL / sodium 20 MEQ) in 5 ML InjectionPSN5bf47be3-f3fe-452b-8113-9417964983455
1872447sodium phosphates (phosphorus 150 MMOL / sodium 200 MEQ) in 50 ML InjectionPSN5bf47be3-f3fe-452b-8113-9417964983455
1872384sodium phosphates (phosphorus 45 MMOL / sodium 60 MEQ) in 15 ML InjectionPSN5bf47be3-f3fe-452b-8113-9417964983455
187238415 ML sodium phosphate, dibasic 142 MG/ML / sodium phosphate, monobasic 276 MG/ML InjectionSCD5bf47be3-f3fe-452b-8113-9417964983455
18724435 ML sodium phosphate, dibasic 142 MG/ML / sodium phosphate, monobasic 276 MG/ML InjectionSCD5bf47be3-f3fe-452b-8113-9417964983455
187244750 ML sodium phosphate, dibasic 142 MG/ML / sodium phosphate, monobasic 276 MG/ML InjectionSCD5bf47be3-f3fe-452b-8113-9417964983455
1872384phosphorus 45 MMOL / sodium 60 MEQ per 15 ML InjectionSY5bf47be3-f3fe-452b-8113-9417964983455
1872384sodium phosphate, dibasic 2.13 GM / sodium phosphate, monobasic 4.14 GM per 15 ML InjectionSY5bf47be3-f3fe-452b-8113-9417964983455
1872443sodium phosphates (phosphorus 15 MMOL / sodium 20 MEQ) per 5 ML InjectionSY5bf47be3-f3fe-452b-8113-9417964983455
1872447sodium phosphates (phosphorus 150 MMOL / sodium 200 MEQ) per 50 ML InjectionSY5bf47be3-f3fe-452b-8113-9417964983455
1872384sodium phosphates (phosphorus 45 MMOL / sodium 60 MEQ) per 15 ML InjectionSY5bf47be3-f3fe-452b-8113-9417964983455

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63323-881-016332308810115 mL in 1 VIAL, SINGLE-DOSE15 mlHistorical
63323-881-166332308811625 VIAL, SINGLE-DOSE in 1 TRAY (63323-881-16) / 15 mL in 1 VIAL, SINGLE-DOSE (63323-881-01) 2022-03-300000-00-00NoNoCurrent