FDA Orange Book
Generic for Hicon
Hicon contains sodium iodide i-131. 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
Yes. The generic name for Hicon is sodium iodide i-131. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA. Generics match 1 of the 4 Hicon products the Orange Book lists.
Run it in Rivvi
Map Hicon and your other top fills to their generics
Every strength in RxNorm, with brands that have no generic flagged.
Build the mapFree to start. Opens Rivvi, the AI workspace for healthcare teams.
Hicon products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, oral | 1-1000mCi/ML | Discontinued | None | 0 | None |
| solution, oral | 1-250mCi/0.25ML | Discontinued | None | 0 | None |
| solution, oral | 1-500mCi/0.5ML | Discontinued | None | 0 | None |
| solution, oral | 250-1000mCi | Marketed (Rx) | AA | 1 | AA |
NDA 021305, held by JUBILANT DRAXIMAGE INC DBA JUBILANT RADIOPHARMA. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic sodium iodide i-131
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| INTERNATIONAL ISOTOPES INC | 209166 | AA (A-rated, therapeutically equivalent) | February 5, 2020 | 250-1000mCi |
Hicon NDC codes
Questions
Is there a generic for Hicon?
Yes. The generic name for Hicon is sodium iodide i-131. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA. Generics match 1 of the 4 Hicon products the Orange Book lists.
What is the generic name for Hicon?
The active ingredient in Hicon is sodium iodide i-131, 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.