FDA Orange Book · active-ingredient family
Sodium iodide i-131
Sodium iodide i-131 is approved as 6 brand and 2 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:SODIUM IODIDE I 131 · NDA 021305
6
Brand (NDA)
2
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, solution
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| SODIUM IODIDE I 131RLD×6 | JUBILANT | NDA 021305 | — | May 19, 2005 | |
| SODIUM IODIDE I 131RLD×2 | CURIUM | NDA 016515 | — | Approved Prior to Jan 1, 1982 | |
| SODIUM IODIDE I 131RLD×2 | CURIUM | NDA 016517 | — | Approved Prior to Jan 1, 1982 | |
| IODOTOPE×3 | BRACCO | NDA 010929 | — | Approved Prior to Jan 1, 1982 | |
| SODIUM IODIDE I 131×2 | CIS | NDA 017316 | — | Approved Prior to Jan 1, 1982 | |
| SODIUM IODIDE I 131 | SUN PHARM INDS INC | NDA 017315 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (2)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| SODIUM IODIDE I 131 | CARDINAL HLTH 414 | ANDA 213615 | — | Jun 12, 2025 | |
| SODIUM IODIDE I 131 | INTL ISOTOPES | ANDA 209166 | AA | Feb 05, 2020 |
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Sodium iodide i-131 — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
