FDA Orange Book · active-ingredient family
Calcium gluconate
Calcium gluconate is approved as 2 brand and 7 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:CALCIUM GLUCONATE · NDA 210906
2
Brand (NDA)
7
Generics (ANDA)
2
Listed patents
0
Exclusivity periods
Brand (NDA) products · solution
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CALCIUM GLUCONATERLD×4 | HQ SPCLT PHARMA | NDA 210906 | — | Nov 18, 2025 | |
| CALCIUM GLUCONATERLD×5 | FRESENIUS KABI USA | NDA 208418 | AP | Jun 15, 2017 |
Generic (ANDA) products (7)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CALCIUM GLUCONATE×3 | CAPLIN | ANDA 218840 | AP | May 04, 2026 | |
| CALCIUM GLUCONATE IN SODIUM CHLORIDE×2 | SAGENT | ANDA 219619 | AP | Dec 30, 2025 | |
| CALCIUM GLUCONATE×3 | AMNEAL | ANDA 216611 | AP | May 10, 2024 | |
| CALCIUM GLUCONATE×2 | SOMERSET | ANDA 217689 | AP | Oct 19, 2023 | |
| CALCIUM GLUCONATE IN SODIUM CHLORIDE×2 | AMNEAL | ANDA 217174 | AP | Sep 05, 2023 | |
| CALCIUM GLUCONATE | B BRAUN MEDICAL | ANDA 216541 | AP | Aug 21, 2023 | |
| CALCIUM GLUCONATE×3 | NIVAGEN PHARMS INC | ANDA 213071 | AP | Oct 14, 2022 |
Listed patents (2)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10130646 | Jul 25, 2037 | in 11 yr 3 mo | Product |
| 10342813 | Jul 25, 2037 | in 11 yr 3 mo | Product |
Calcium gluconate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
