FDA Orange Book · active-ingredient family
Zinc chloride
Zinc chloride is approved as 1 brand and 3 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:ZINC CHLORIDE IN PLASTIC CONTAINER · NDA 018959
1
Brand (NDA)
3
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ZINC CHLORIDE IN PLASTIC CONTAINERRLD | HOSPIRA | NDA 018959 | AP | Jun 26, 1986 |
Generic (ANDA) products (3)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ZINC CHLORIDE | STIRA | ANDA 217625 | AP | Apr 14, 2025 | |
| ZINC CHLORIDE | SOMERSET | ANDA 216152 | AP | Oct 16, 2024 | |
| ZINC CHLORIDE | EXELA PHARMA | ANDA 212007 | AP | May 21, 2021 |
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.
Zinc chloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

