POTASSIUM PHOSPHATES

Product NDC
80830-1693
11-digit product format
808301693
Labeler code
80830
Product ID
80830-1693_d20a884f-9cba-4621-91ee-6e0ba6e361ca
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
potassium phosphate, monobasic potassium phosphate, dibasic injection,
Dosage form
SOLUTION, CONCENTRATE
Route
INTRAVENOUS
Labeler
Amneal Pharmaceuticals Private Limited
Application
ANDA216344
Marketing category
ANDA
Marketing start
2023-10-23
Substance
POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC
Active strength
236; 224 mg/mL; mg/mL
Pharmacologic classes
Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Compounds [CS], Potassium Salt [EPC], Potassium Salt [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
POTASSIUM PHOSPHATES
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POTASSIUM PHOSPHATE, DIBASIC236 mg/mL
POTASSIUM PHOSPHATE, MONOBASIC224 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4J9FJ0HL51, CI71S98N1Z
Rxcui1928567, 1928569, 1928570

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9e37788c-b1bf-42ae-aac9-b60601606144Product name820260122
95250459-30e4-45c1-b08a-993044f49109Product name220250805
d9771140-739b-484b-ae64-b79528ff1211Product name320250801
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
4b7700e3-6e0e-45e5-9d22-6f754d61386eProduct name220250304
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
1527ac37-808d-43be-a63e-74e1258dbe46Product name920250219
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
9fcb7a91-de07-4f00-aabf-e4d6fda403d5Product name820230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
0ec3537a-6c9b-432a-896c-b9ea8723049aProduct name920200701
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
7916de40-e296-41f0-b811-6d0df1a33e2cProduct name920180627
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
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
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct 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
80830-1693-1POTASSIUM PHOSPHATES5 mL in 1 VIAL, SINGLE-DOSESOLUTION, CONCENTRATE59
80830-1693-3POTASSIUM PHOSPHATES5 in 1 CARTONSOLUTION, CONCENTRATE59
80830-1693-5POTASSIUM PHOSPHATES25 in 1 CARTONSOLUTION, CONCENTRATE259

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80830-1693-1ML - Milliliter80830-1693c16a31b6-fc57-4923-8058-e53b0718c57f12023-12-05
80830-1693-3ML - Milliliter80830-1693fffd2af2-67a8-4d96-9b49-fefb1133f9c412023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80830-1693POTASSIUM PHOSPHATES (POTASSIUM PHOSPHATE, MONOBASIC POTASSIUM PHOSPHATE, DIBASIC INJECTION,) SOLUTION, CONCENTRATE [AMNEAL PHARMACEUTICALS PRIVATE LIMITED]9Current NDC, 3 package rows20250108_89136c51-a60b-4269-bd05-9489f060a734.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1928567potassium phosphates (phosphorus 15 MMOL / potassium 22 MEQ) in 5 ML InjectionPSN89136c51-a60b-4269-bd05-9489f060a7349
1928570potassium phosphates (phosphorus 150 MMOL / potassium 220 MEQ) in 50 ML InjectionPSN89136c51-a60b-4269-bd05-9489f060a7349
1928569potassium phosphates (phosphorus 45 MMOL / potassium 66 MEQ) in 15 ML InjectionPSN89136c51-a60b-4269-bd05-9489f060a7349
192856915 ML dibasic potassium phosphate 236 MG/ML / monobasic potassium phosphate 224 MG/ML InjectionSCD89136c51-a60b-4269-bd05-9489f060a7349
19285675 ML dibasic potassium phosphate 236 MG/ML / monobasic potassium phosphate 224 MG/ML InjectionSCD89136c51-a60b-4269-bd05-9489f060a7349
192857050 ML dibasic potassium phosphate 236 MG/ML / monobasic potassium phosphate 224 MG/ML InjectionSCD89136c51-a60b-4269-bd05-9489f060a7349
192856915 ML Dibasic K+ phosphate 236 MG/ML / Monobasic K+ phosphate 224 MG/ML InjectionSY89136c51-a60b-4269-bd05-9489f060a7349
192856915 ML Dibasic Pot phosphate 236 MG/ML / Monobasic Pot phosphate 224 MG/ML InjectionSY89136c51-a60b-4269-bd05-9489f060a7349
19285675 ML Dibasic K+ phosphate 236 MG/ML / Monobasic K+ phosphate 224 MG/ML InjectionSY89136c51-a60b-4269-bd05-9489f060a7349
19285675 ML Dibasic Pot phosphate 236 MG/ML / Monobasic Pot phosphate 224 MG/ML InjectionSY89136c51-a60b-4269-bd05-9489f060a7349
192857050 ML Dibasic K+ phosphate 236 MG/ML / Monobasic K+ phosphate 224 MG/ML InjectionSY89136c51-a60b-4269-bd05-9489f060a7349
192857050 ML Dibasic Pot phosphate 236 MG/ML / Monobasic Pot phosphate 224 MG/ML InjectionSY89136c51-a60b-4269-bd05-9489f060a7349
1928567phosphorus 15 MMOL / potassium 22 MEQ per 5 ML InjectionSY89136c51-a60b-4269-bd05-9489f060a7349
1928570phosphorus 150 MMOL / potassium 220 MEQ per 50 ML InjectionSY89136c51-a60b-4269-bd05-9489f060a7349
1928569phosphorus 45 MMOL / potassium 66 MEQ per 15 ML InjectionSY89136c51-a60b-4269-bd05-9489f060a7349
1928567potassium phosphates (phosphorus 15 MMOL / potassium 22 MEQ) per 5 ML InjectionSY89136c51-a60b-4269-bd05-9489f060a7349
1928570potassium phosphates (phosphorus 150 MMOL / potassium 220 MEQ) per 50 ML InjectionSY89136c51-a60b-4269-bd05-9489f060a7349
1928569potassium phosphates (phosphorus 45 MMOL / potassium 66 MEQ) per 15 ML InjectionSY89136c51-a60b-4269-bd05-9489f060a7349

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80830-1693-1808301693015 mL in 1 VIAL, SINGLE-DOSE5 mlHistorical
80830-1693-3808301693035 VIAL, SINGLE-DOSE in 1 CARTON (80830-1693-3) / 5 mL in 1 VIAL, SINGLE-DOSE (80830-1693-1) 2023-10-23NoNoCurrent
80830-1693-58083016930525 VIAL, SINGLE-DOSE in 1 CARTON (80830-1693-5) / 5 mL in 1 VIAL, SINGLE-DOSE (80830-1693-1) 2023-10-23NoNoCurrent