FDA Orange Book
Is there a generic for Tis-u-sol?
Tis-u-sol contains magnesium sulfate, potassium chloride, potassium phosphate monobasic, sodium chloride and sodium phosphate. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
No. The Orange Book lists no active FDA-approved generic (ANDA) for Tis-u-sol (magnesium sulfate, potassium chloride, potassium phosphate monobasic, sodium chloride and sodium phosphate).
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Tis-u-sol products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, irrigation | 20MG/100ML;40MG/100ML;6.25MG/100ML;800MG/100ML;8.75MG/100ML | Marketed (Rx) | AT | 0 | None |
NDA 018508, held by BAXTER HEALTHCARE CORP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Tis-u-sol NDC codes
Questions
Is there a generic for Tis-u-sol?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Tis-u-sol (magnesium sulfate, potassium chloride, potassium phosphate monobasic, sodium chloride and sodium phosphate).
What is the generic name for Tis-u-sol?
The active ingredient in Tis-u-sol is magnesium sulfate, potassium chloride, potassium phosphate monobasic, sodium chloride and sodium phosphate, per the FDA Orange Book.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.