Active ingredient
Calcium Gluconate
38 finished FDA listings contain Calcium Gluconate as their only active ingredient; 6 combination products also contain it.
FDA NDC Directory
- Ingredient names as written by FDA
- CALCIUM GLUCONATE, CALCIUM GLUCONATE MONOHYDRATE
- Dosage forms
- Injection, Solution
- Routes
- Intravenous
- Manufacturers / labelers
- 13
- Strengths listed
- 10 mg/ml · 100 mg/ml · 20 mg/ml · 98 mg/ml
- Brand names in FDA listings
- Calcium Gluconate In Sodium Chloride
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 1908
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 208418 | FRESENIUS KABI USA | 2017-06-15 | 10 |
| NDA 210906 | HQ SPCLT PHARMA | 2018-10-29 | 6 |
| ANDA 213071 | NIVAGEN | 2022-10-14 | 5 |
| ANDA 216541 | B BRAUN MEDICAL | 2023-08-21 | 1 |
| ANDA 217174 | AMNEAL | 2023-09-05 | 2 |
| ANDA 217689 | SOMERSET | 2023-10-19 | 2 |
| ANDA 216611 | AMNEAL | 2024-05-10 | 6 |
| ANDA 218840 | CAPLIN | 2026-05-04 | 6 |
Official labeling on DailyMed
- CALCIUM GLUCONATE INJECTION, SOLUTION [REMEDYREPACK INC.] · version 3 · 2026-09-10
- CALCIUM GLUCONATE INJECTION, SOLUTION [AMNEAL PHARMACEUTICALS PRIVATE LIMITED] · version 3 · 2026-06-24
- CALCIUM GLUCONATE INJECTION, SOLUTION [GLENMARK PHARMACEUTICALS INC., USA] · version 1 · 2026-06-12
- CALCIUM GLUCONATE (CALCIUM GLUCONATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC · version 7 · 2026-06-04
- CALCIUM GLUCONATE INJECTION, SOLUTION [AMNEAL PHARMACEUTICALS PRIVATE LIMITED] · version 4 · 2026-06-04
- CALCIUM GLUCONATE INJECTION, SOLUTION [CAPLIN STERILES LIMITED] · version 1 · 2026-05-14
- CALCIUM GLUCONATE INJECTION, SOLUTION [HENRY SCHEIN, INC.] · version 1 · 2025-12-25
- CALCIUM GLUCONATE INJECTION, SOLUTION [HENRY SCHEIN, INC.] · version 7 · 2025-11-17
- CALCIUM GLUCONATE INJECTION, SOLUTION [REMEDYREPACK INC.] · version 3 · 2025-10-01
- CALCIUM GLUCONATE IN SODIUM CHLORIDE (CALCIUM GLUCONATE) INJECTION, SOLUTION [WG CRITICAL CARE, LLC] · version 3 · 2025-09-22
- CALCIUM GLUCONATE INJECTION, SOLUTION [PROPHARMA DISTRIBUTION] · version 2 · 2025-07-21
- CALCIUM GLUCONATE INJECTION, SOLUTION [AMNEAL PHARMACEUTICALS PRIVATE LIMITED] · version 16 · 2025-05-22
Showing the 12 most recent of 22 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.