Quick answers
- What is Sodium phosphate, monobasic, monohydrate and sodium phosphate, dibasic anhydrous used for?
- The FDA-approved label (Sodium Phosphates, Hospira, Inc., May 11, 2026) says: “Sodium Phosphates Injection, USP, 3 mM P/mL is indicated as a source of phosphorus, for addition to large volume intravenous fluids, to prevent or correct hypophosphatemia in patients with restricted or no oral intake. It is also useful as an additive for preparing specific parenteral fluid formulas when the needs of the patient cannot be met by standard electrolyte or nutrient solutions. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Sodium phosphate, monobasic, monohydrate and sodium phosphate, dibasic anhydrous have a boxed warning?
- The label we quote has no boxed warning, but 1 of 5 FDA labels for this medicine do. Check the label of your own product.
- Is there a shortage of Sodium phosphate, monobasic, monohydrate and sodium phosphate, dibasic anhydrous?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Sodium phosphate, monobasic, monohydrate and sodium phosphate, dibasic anhydrous been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Sodium phosphate, monobasic, monohydrate and sodium phosphate, dibasic anhydrous?
- 5 companies list prescription products of Sodium phosphate, monobasic, monohydrate and sodium phosphate, dibasic anhydrous in the FDA NDC Directory, including American Regent, Inc., Fresenius Kabi USA, LLC and Civica, Inc..
What Sodium phosphate, monobasic, monohydrate and sodium phosphate, dibasic anhydrous is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Sodium Phosphates Injection, USP, 3 mM P/mL is indicated as a source of phosphorus, for addition to large volume intravenous fluids, to prevent or correct hypophosphatemia in patients with restricted or no oral intake. It is also useful as an additive for preparing specific parenteral fluid formulas when the needs of the patient cannot be met by standard electrolyte or nutrient solutions. …
— FDA label: Sodium Phosphates, Hospira, Inc., effective May 11, 2026. Read the full label on DailyMed →
The FDA has 5 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
1 of 5 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, solution · Tablet |
|---|---|
| Route | Intravenous · Oral |
| Prescription products | 9 in the FDA NDC Directory |
| Brand names | Sodium Phosphates |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- American Regent, Inc.3 products
- Fresenius Kabi USA, LLC3 products
- Civica, Inc.1 product
- Lupin Pharmaceuticals, Inc.1 product
- Hospira, Inc.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA018892 SODIUM PHOSPHATES IN PLASTIC CONTAINER | Hospira | May 10, 1983 | 22, latest November 30, 2023 2023: Manufacturing (CMC) · 2023: Manufacturing (CMC) · 2015: Manufacturing (CMC) |
Generic approvals (3)
- ANDA079247Novel Labs Inc · December 30, 2011
- ANDA209997Fresenius Kabi USA · March 30, 2022
- ANDA218314Am Regent · June 21, 2024
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 1872384, 1872443, 1872447 |
|---|---|
| SPL set ID of the quoted label | 6f044d16-295e-43ff-72a3-b045c387bc5c |
| FDA labels (SPL) | 5 |
| FDA applications | NDA018892, 3 ANDA |
| Active ingredients (FDA) | SODIUM PHOSPHATE, DIBASIC, ANHYDROUS / SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Sodium Phosphates, Hospira, Inc., effective May 11, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →