Orange Book product · Brand (NDA)
CALCIUM GLUCONATE
CALCIUM GLUCONATE
At a glance
Nov 18, 2025
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 18, 2025
7 mo ago
Today
Pharmaceutical detail
Active ingredient
CALCIUM GLUCONATE
Strength
10GM/100ML (100MG/ML)
Dosage form
SOLUTION
Route
INTRAVENOUS
TE code
Not listed
Application
NDA 210906
Product number
004
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2017CALCIUM GLUCONATEBrand (NDA)
NDA 208418 · FRESENIUS KABI USA
- 2026CALCIUM GLUCONATEGeneric (ANDA)
ANDA 218840 · CAPLIN
- 2025CALCIUM GLUCONATE IN SODIUM CHLORIDEGeneric (ANDA)
ANDA 219619 · SAGENT
- 2024CALCIUM GLUCONATEGeneric (ANDA)
ANDA 216611 · AMNEAL
- 2023CALCIUM GLUCONATEGeneric (ANDA)
ANDA 217689 · SOMERSET
- 2023CALCIUM GLUCONATE IN SODIUM CHLORIDEGeneric (ANDA)
ANDA 217174 · AMNEAL
- 2023CALCIUM GLUCONATEGeneric (ANDA)
ANDA 216541 · B BRAUN MEDICAL
- 2022CALCIUM GLUCONATEGeneric (ANDA)
ANDA 213071 · NIVAGEN PHARMS INC
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.
