Prescription medicine
Potassium phosphate dibasic and potassium phosphate monobasic
Potassium phosphate dibasic and potassium phosphate monobasic is a prescription medicine with an FDA approval on record since 2019. FDA's NDC Directory lists it from 3 generic labelers.
- Generic listed
Check it at the source: the potassium phosphate dibasic and potassium phosphate monobasic FDA label on DailyMed (effective December 31, 2024, Amneal Pharmaceuticals Private Limited); the NDA 212121 record on Drugs@FDA; every potassium phosphate dibasic and potassium phosphate monobasic label on DailyMed.
Highlights of the record
FDA label of December 31, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usagePotassium phosphates injection is indicated as a source of phosphorus: in intravenous fluids to correct hypophosphatemia in adults and pediatric patients when oral or enteral replacement is not possible, insufficient or contraindicated.
Forms and strengths
- 4.48 mg/ml / 4.72 mg/ml
- 224 mg/ml / 236 mg/ml
Solution (concentrate); injection (solution); injection (solution) (concentrate); injection.
On the market
- Earliest approval on file
- September 19, 2019 Potassium Phosphates, Cmp Dev Llc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 6 first October 2, 2023; 6 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 4 of which 3 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- October 12, 2041 Potassium Phosphates injection; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 867 through July 30, 2026
What is potassium phosphate dibasic and potassium phosphate monobasic used for?
From the label: indications and usagePotassium phosphates injection is indicated as a source of phosphorus: in intravenous fluids to correct hypophosphatemia in adults and pediatric patients when oral or enteral replacement is not possible, insufficient or contraindicated. for parenteral nutrition in adults and pediatric patients when oral or enteral nutrition is not possible, insufficient or contraindicated. Potassium phosphates injection is a phosphorus replacement product indicated as a source of phosphorus: in intravenous fluids to correct hypophosphatemia in adults and pediatric patients when oral or enteral replacement is not possible, insufficient or contraindicated. […]
FDA pharmacologic class: Osmotic Laxative and Potassium Salt.
Source: FDA drug label (POTASSIUM PHOSPHATES), Amneal Pharmaceuticals Private Limited, effective December 31, 2024 (SPL set 89136c51-a60b-4269-bd05-9489f060a734), via openFDA; the full label on DailyMed
Is there a generic for potassium phosphate dibasic and potassium phosphate monobasic?
The FDA approved the first generic potassium phosphate dibasic and potassium phosphate monobasic on October 2, 2023. 6 generic applications are approved; 6 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists potassium phosphate dibasic and potassium phosphate monobasic from 3 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists 2 patents for Potassium Phosphates injection, the last expiring on October 12, 2041. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2019 earliest approval on file
- 2023 first generic approved
- 2041 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the potassium phosphate dibasic and potassium phosphate monobasic label say about other medicines?
The potassium phosphate dibasic and potassium phosphate monobasic label names 3 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Cyclosporine | drug interactions | … diuretics, ACE inhibitors, angiotensin II receptor antagonists, digoxin or the immunosuppressants tacrolimus and cyclosporine) increases the risk of severe and potentially fatal hyperkalemia, in particular in the presence of other risk factors for hyperkalemia [see Warnings and Precautions (5.3) ]. |
| Digoxin | drug interactions | Products that Increase Serum Potassium Administration of potassium phosphates injection to patients treated concurrently or recently with products that increase serum potassium (e.g., potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists, digoxin or the immunosuppressants tacrolimus and … |
| Tacrolimus | drug interactions | … potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists, digoxin or the immunosuppressants tacrolimus and cyclosporine) increases the risk of severe and potentially fatal hyperkalemia, in particular in the presence of other risk factors for hyperkalemia [see Warnings and Precautions (5.3) ]. |
Check potassium phosphate dibasic and potassium phosphate monobasic against other medicines
Source: FDA drug label (POTASSIUM PHOSPHATES), Amneal Pharmaceuticals Private Limited, effective December 31, 2024 (SPL set 89136c51-a60b-4269-bd05-9489f060a734), via openFDA; the full label on DailyMed
What do FAERS reports show for potassium phosphate dibasic and potassium phosphate monobasic?
The FDA Adverse Event Reporting System holds 867 reports that list potassium phosphate dibasic and potassium phosphate monobasic among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 170 are coded as a death and 511 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other osmotic laxatives
- the pharmacologic class, with prices and generics
- Potassium phosphate dibasic and potassium phosphate monobasic side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other